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Deutsches Ärzteblatt International logoLink to Deutsches Ärzteblatt International
. 2016 Jun 24;113(25):423–430. doi: 10.3238/arztebl.2016.0423

Improving Treatment Adherence in Heart Failure

A Systematic Review and Meta-analysis of Pharmacological and Lifestyle Interventions

Susanne Unverzagt 1, Gabriele Meyer 2, Susanne Mittmann 3, Franziska-Antonia Samos 3, Malte Unverzagt 4, Roland Prondzinsky 5,*
PMCID: PMC4941608  PMID: 27397013

Abstract

Background

Despite improved treatment options, heart failure remains the third most common cause of death in Germany and the most common reason for hospitalization. The treatment recommendations contained in the relevant guidelines have been incompletely applied in practice. The goal of this systematic review is to study the efficacy of adherence-promoting interventions for patients with heart failure with respect to the taking of medications, the implementation of recommended lifestyle changes, and the improvement in clinical endpoints.

Methods

We performed a meta-analysis of pertinent publications retrieved by a systematic literature search.

Results

55 randomized controlled trials were identified, in which a wide variety of interventions were carried out on heterogeneous patient groups with varying definitions of adherence. These trials included a total of 15 016 patients with heart failure who were cared for as either inpatients or outpatients. The efficacy of interventions to promote adherence to drug treatment was studied in 24 trials; these trials documented improved adherence in 10% of the patients overall (95% confidence interval [CI]: [5; 15]). The efficacy of interventions to promote adherence to lifestyle recommendations was studied in 42 trials; improved adherence was found in 31 trials. Improved adherence to at least one recommendation yielded a long-term absolute reduction in mortality of 2% (95% CI: [0; 4]) and a 10% reduction in the likelihood of hospitalization within 12 months of the start of the intervention (95% CI: [3; 17]).

Conclusion

Many effective interventions are available that can lead to sustained improvement in patient adherence and in clinical endpoints. Long-term success depends on patients’ assuming responsibility for their own health and can be achieved with the aid of coordinated measures such as patient education and regular follow-up contacts.


In spite of improved treatment options, heart failure is the third most common cause of death in Germany and constitutes the most common cause for inpatient admission to hospital (1). This disease burden has remained unchanged at this high level for patients and the healthcare system in spite of falling cardiovascular death rates (25) and the successful development of medication treatments. The efficacy of these therapies has been shown in large multicenter studies across all stages and grades of severity of the disorder. This holds true for the introduction of angiotensin converting enzyme (ACE) inhibitors, beta receptor blockers, antiotensin-1 antagonists, and aldosterone antagonists (610).

The prognosis for patients can additionally be improved effectively by disorder-specific lifestyle modifications and optimized self-care. These measures include, among others:

  • Monitoring for fluid retention by means of regular control of body weight and checking for leg edema (11, 12)

  • Independent adjustment of the medication according to agreed schemes

  • Putting dietary recommendations into practice (13).

These therapeutic recommendations have found their way into the current guidelines regarding healthcare provision for patients with heart failure (1416), but they are realized in patients’ everyday lives to an unsatisfactory degree. In this setting, the term adherence describes the extent to which a patient’s behavior with regard to medication intake or lifestyle changes is consistent with therapeutic recommendations (17). In contrast to the term compliance, which was used in the past, adherence implies a therapeutic alliance between doctor and patient, with joint decision making and support for self-care.

In recent years it has been shown repeatedly that in evidence-based and prognosis-relevant treatment measures, a clear interaction exists between adherence and the subsequent prognosis. In a recent cohort study, non-adherent patients accounted for 22.1% of all hospital admissions for clinically manifest heart failure, and they had a markedly shorter time interval until readmission to hospital (hazard ratio [HR] 0.45; 95% confidence interval [CI]: [0.25; 0.52]) (18). It is well known that low adherence to antihypertensive treatment notably increases the risk for clinically manifest heart failure (19).

On the background of the great prognostic importance of limited adherence in chronic heart failure, this systematic review aims to answer the following questions:

  • Is it possible to support patients with heart failure and to improve their adherence to medication therapy and lifestyle modifications in a sustained fashion?

  • Is improved adherence on the patients’ part associated with improved clinical outcomes, such as lower mortality, fewer inpatient stays in hospital, and improved quality of life?

Methods

This systematic review aims to summarize all randomized intervention studies of the improvement of adherence in patients with heart failure. The Box shows the inclusion criteria.

Box. Inclusion criteria.

  • Population

    Patients with heart failure

  • Intervention

    Strategies to improve patients’ adherence to taking their medication and self care

    • Training/education for patients

    • Reminder systems for patients

    • Measures to improve self care

    • Doctor oriented strategies

    • Organizational changes

    • Technical solutions

  • Control group

    Standard care or other (less intensive) implementation strategy

  • Endpoint

    Patients’ adherence after a minimum of 3 months’ follow-up to

    • Regular medication intake (for example, of ACE inhibitors or AT1 antagonists, beta-blockers, diuretics)

    • Symptom and weight control to detect fluid retention early

    • Low-salt diet

    • Restricted fluid intake

    • Support for/promotion of moderate physical activity

    • Avoidance of risk factors (for example, smoking)

ACE, angiotensin converting enzyme; AT, angiotensin

Literature search

The study was conducted on the basis of the registered (reg No CRD42014009477) and published study protocol (20). The results were reported in accordance with the PRISMA guidelines (21). We searched the databases Medline (Ovid), EMBASE, CENTRAL, PsycInfo, and CINAHL in July 2014 for all suitable studies that had been published since 2000 in English or German. In addition, we manually searched the reference lists of the included studies and systematic reviews.

Study selection and data extraction

The authors SU, FS, or SM checked—independently from one another—titles, summaries/abstracts, and potentially relevant full-text versions on the basis of the inclusion criteria. Information on patients’ adherence was described by using frequency data or scores on medication intake (eTable 1) and implementation of lifestyle modifications (eTable 2). In order to ensure that patients stuck to the interventions, a follow-up period of at least 3 months was a prerequisite for inclusion. Disagreements on the inclusion of studies were discussed with RP. Subsequently, the information set out in the study protocol was extracted by FS and SM and checked by MU. In addition to process parameters on adherence, we also collected data on patient-relevant result parameters, such as quality of life, mortality, and frequency and duration of hospital inpatient stays. The methodological quality of the studies was assessed on the basis of the recommendations of the Cochrane Collaboration (22).

eTable 1. Measurement of adherence to medications.

Adherence to Studies with maximal follow-up period (method)
Measurement over frequencies
Prescribed medications 6-9 Months: e1 (MEMS), e2 (self-reporting), e3 (MEMS), e4 (self-reporting), e5 (MEMS)
12 Months: e6, e7-e12 (self-reporting), e13 (tablet accountability method), e14 (self-reporting), e15 (MEMS)
Beta-Blockers 3 Months: e3 (MEMS)
12 Months: e12, e14, e16, e17 (self-reporting)
ACE-inhibitors / ARB 3 Months : e3 (MEMS)
6-9 Months: e18 (self-reporting)
12 Months: e12, e14, e16, e19 (self-reporting)
Diuretica / spironolactone 3 Months: e3 (MEMS)
12 Months: e12 (self-reporting)
MRA 12 Months: e14 (self-reporting)
Furoseminide 12 Months: e12 (self-reporting)
Measurement over scores
Prescribed medications 3 Months: e20, e21 (self-reporting)
6-9 Months: e22 (MARS)
12 Months: e23 and e24, e25 (Morisky-Score), e26 (selfreporting)

MARS, medication adherence record scale; MEMS, medication event monitoring; MRA, mineralocorticoid receptor antagonist

eTable 2. Measurement of adherence to self-care management.

Measurement tool Studies with maximal follow-up period
Scores on multiple recommendations
EHFScBS (13) and modifications* 3 Months: e27*-e29*, e30*
6-9 Months: e31, e32, e33*, e34*
12 Months: e24, e35-e37, e38*, e39
SCHFI (e42) and modifications* 3 Months: e40*, e41, e42,, e43*, e44*
6-9 Months: e45*, e46*, e47
Further scores, developed for studies 3 Months: e6*e20, e28, e48
6-9 Months: e26, e47, e49
12 Months: e25, e50*
Self-efficacy 3 Months: e20, e30, e51
6-9 Months: e4
12 Months: e15, e52
Single recommendations
Daily weight and symptom control 3 Months: e21, e27, e53
6-9 Months: e54
12 Months: e10, e23; e52, e55
Restrictions to sodium intake 3 Months: e6, e20, e21, e56
6-9 Months: e2,e26, e57
12 Months: e10, e12, e15, e23
Restrictions to fluid intake 3 Months: e6, e21, e56
12 Months: e23
Exercise adherence 3 Months:e6, e20
12 Months: e10, e23
Smoking cessation adherence 3 Months:e20
12 Months: e23

EHFScBS, European Heart Failure Self Care Behaviour Scale; SCHFI, Self-Care of Heart Failure

Index

Effect sizes

We calculated the effect size by comparing the frequencies of adherent behavior in the intervention and control groups. Furthermore, we calculated risk differences (RD) and numbers needed to treat (NNT). For metrically captured adherence we determined standardized mean differences (SMD). Positive differences describe improved adherence in the intervention group. The SMD allows for comparability of adherence, which was quantified by using several scores (23) and also shows the extent of the standard deviations by which each score was improved by applying the strategies. The treatment effects in the individual studies were summarized by using the random effects model, and the risk of publication bias was investigated by using a funnel plot.

Results

The systematic search identified 5340 potentially relevant articles. After checking titles and abstracts and reading 211 full text articles, we included 55 studies in our review. Altogether 24 studies reported on adherence to medication therapy and 42 studies on lifestyle modifications; 11 studies reported on both subjects (Figure 1).

Figure 1.

Figure 1

How the literature search was undertaken

Description of included studies

The 55 studies that were included in this review had been conducted in 17 countries on four continents and investigated the efficacy of adherence-improving measures in a total of 15 016 patients with heart failure. All studies had used a randomized design; as a rule, randomization took place at the level of the patients and in two studies at the level of doctors’ practices.

Patients

Patients were recruited after an acute event in hospital in 39 studies; in 16 studies, they were recruited in a stable condition in the outpatient setting. 62% of study participants were men; three studies included men only. The mean age ranged between 51 years and 78 years. Patients were affected by different limitations in terms of physical resilience and comorbidities such as diabetes, hypertension, fat metabolism disorders, chronic renal failure, or depression. Individual studies excluded patients with severe psychological or cognitive impairments (15 studies), and others excluded patients with renal failure (11 studies).

Interventions

In most studies, several types of intervention were combined so as to improve adherence by various means—and thus a patient’s prognosis.

Training/education sessions for patients—All studies described training measures for patients on the following topics: disease course and how to deal with the disorder, necessary therapeutic steps, early detection of deteriorating symptoms, and necessary lifestyle modifications. The training sessions were provided on the basis of individual treatment plans by nursing staff or pharmacists and were complemented by lectures, discussion services, brochures, newsletters, computer programs, or other learning materials—interactive ones, in some cases.

Patient reminder systems (22 studies)—These were based on regular telephone calls or home visits by specialized nursing staff, doctors’ assistants, or pharmacists. Details of disease symptoms and adherence were recorded and discussed.

Support for self-care (32 studies)—This included all measures that enabled patients to better deal with their disorder, such as: independent use of measuring instruments, keeping a heart failure diary, schemes for diuretic adjustment, pill organizers, medication lists, or an advisory hotline.

Doctor-oriented interventions (11 studies)—In these, optimized or simplified therapeutic plans and suggestions for how to support patients were developed by pharmacists, nursing staff, or practice assistants; these were made available to treating physicians.

Organizational change (21 studies)—These concerned a restructuring of the tasks involved in caring for the patient during an inpatient stay and after discharge, between primary care physicians, cardiologists, psychologists, pharmacists, and nursing staff. Clinical investigations were undertaken—often by nursing staff—for the purpose of symptom monitoring and advice given on lifestyle modifications and diuretic adjustment.

Telemonitoring systems (13 studies)—These enabled measuring weight, blood pressure, heart rate, and automated prompting for adherence, symptoms, and awareness of medication therapy and lifestyle modifications, as well as direct control by nursing staff/specialized teams.

Potential biases

The greatest restriction to study quality was unblinded self-reported adherence with a potentially high risk of bias in the direction of “desired behavior” (36 studies). Problems in generating randomization or blinded allocation could not be excluded in 23 and 39 studies, respectively. Further limitations resulted from the high rates of dropouts and from per-protocol analyses, which may bias effect sizes (19 studies), deviations between planned and reported endpoints (9 studies), and relevant differences between the intervention groups at the start of the study (14 studies). Publication bias cannot be excluded because negative treatment effects on adherence were rarely reported (eFigure 1, eFigure 2).

eFigure 1.

eFigure 1

SE (RD)

Funnel plot for intervention effects on adherence to medication therapies.

SE, standard error; RD, risk difference

eFigure 2.

eFigure 2

Funnel plot for intervention effects on adherence to lifestyle recommendations.

EHFScBS, European Heart Failure Self-care Behaviour Scale; SCHFI, self care heart failure index; SE, standard error; SMD, standardized mean difference

Efficacy of the interventions

Adherence to medication treatment—This was tested in 24 studies (eTable 1). Combining the treatment effects from 18 studies shows improved adherence in 10% (95% CI [5; 15]) (Figure 2) of patients by means of the intervention under study (number needed to treat [NNT] 10; 95% CI [7; 20]). It was not possible to calculate risk differences for six studies (e2, e10, e20, e22, e25, e26). None of these studies found improved adherence to medication intake.

Figure 2.

Figure 2

Forest plot

of the efficacy of interventions on the frequency of patients’ adherence to medication therapy. I2, heterogeneity

CI, confidence interval

No, number of patients

RD, risk difference

Adherence to lifestyle recommendations—This was investigated in a total of 42 studies and improved in 31 studies (eTable 2). The pooled effects of 22 studies in which adherence was calculated by using different summative scores (24, 25), showed improved adherence in the intervention groups in 12 studies (Table). Improved adherence regarding individual recommendations was reported in 15 out of 18 further studies, with some studies reporting summative scores as well as adherence to individual recommendations. Five studies reported adherence by using different scores for which it was not possible to calculate any differences (e25, e28, e39, e44, e49). In four of these studies, adherence improved successfully.

Table. Studies of the efficacy of interventions on patients’ adherence to lifestyle modifications.

A) EHFscBS and modifications
Intervention Control
Study Mean SD No Mean SD No SMD [95% CI]
e36 0.6 8.2 57 1.3 6.9 63 −0.09 [−0.45 to 0.27]
e27 106 21 9 108 22 9 −0.09 [−1.01 to 0.84]
e35 49.2 6.3 156 49.2 6.6 109 0.00 [−0.24 to 0.24]
e33 10.4 3.1 84 10.1 2.9 95 0.10 [−0.19 to 0.39]
e34  52.2 10.1 29 48.5 9 26 0.38 [-0.15 to 0.91]
e37 −21.2 6.4 65 −24.8 6.7 78 0.55 [0.21 to 0.88]
e24 −17.4 4.5 149 −20.8 5.8 134 0.66 [0.42 to 0.90]
e29 2.9 1 14 1.9 1.3 11 0.85 [0.02 to 1.68]
e31 12.1 10.9 76 3.1 10 75 0.86 [0.52 to 1.19]
e30 −27.1 2.5 47 −30.1 1.7 46 1.39 [0.93 to 1.84]
I² = 83% Random effects model 686 646 0.41 [0.30 to 0.52]
B] SCHFI and modifications
e42 159.2 46.3 27 178.4 29.6 26 −0.48 [−1.03 to 0.06]
e47 65.1 22.7 30 70 19.2 34 −0.23 [−0.72 to 0.26]
e40 2.6 0.67 37 2.2 0.67 39 0.59 [0.13 to 1.05]
e43 19.6 2.1 34 18 2.9 29 0.63 [0.12 to 1.14]
e38 12.4 1 45 10.8 0.9 34 1.65 [1.14 to 2.17]
e50 51.8 5.8 233 39.9 7.9 117 1.81 [1.55 to 2.07]
I² = 95% Random effects model 406 279 1.03 [0.86 to 1.20]
C) Further scores
e59 5.9 2.4 56 6.2 2.5 36 −0.12 [−0.54 to 0.30]
e48 6.1 2.1 40 5.8 1.9 47 0.15 [−0.27 to 0.57]
e24 54.9 6.5 149 52.3 8.9 134 0.34 [0.10 to 0.57]
e34 52.2 10.1 29 48.5 9 26 0.38 [−0.15 to 0.91]
e20 50.6 4.7 18 46.5 4.5 17 0.87 [0.17 to 1.57]
e51 35.9 2.73 108 32.74 3.53 108 1.00 [0.71 to 1.28]
I² = 81% Random effects model 400 368 0.46 [0.31 to 0.60]

EHFScBS, European Heart Failure Self-care Behaviour Scale; I², heterogeneity; CI, confidence interval; No, number of patients per group; SCHFI, self care heart failure index; SD, standard deviation; SMD, standardized mean difference (positive differences describe an advantage for the intervention)

Association between adherence and clinical parameters—44 studies had collected data on the efficacy of the interventions on clinical parameters (mortality, admission to hospital or quality of life). Improved adherence to medication therapy or lifestyle recommendations resulted in 6 and 11 studies, respectively, in significant improvements of at least one clinical endpoint (eTable 3, eTable 4). Improved adherence to at least one of the studied recommendations resulted in the long term in an absolute reduction in mortality of 2 percentage points (95% CI [0; 4]) (17 studies including 6321 patients; eFigure 3) and a 10 percent reduction in the proportion of patients requiring inpatient stays (95% CI [3; 17]) (11 studies including 3368 patients; eFigure 4) within 12 months after the start of the intervention. Only one study investigated and confirmed an association between improved adherence to lifestyle interventions (keeping a heart failure diary) and lower mortality (e55). eTable 5 summarizes all studies that did not find any improvement in clinical endpoints.

eTabelle 3. Studies with improved adherence to medications and improved clinical outcomes in the intervention group.

Article Study type recruit ment Population number, age, male, NYHA (I/II/III/IV), comorbidities Comparison Intervention (IG) vs. control (CG) Risk of bias (I/II/III/IV /V/VI) Patient adherence (measurement, followup) IG vs. CG Conclusions on primary outcome, clinical outcomes and adherence
Antonicelli
2010
(e7)
RCT
Italy
16
months
57 hospitalized HF patients
78±7 years, 61% male NYHA: 0/58/37/5%
Exclusion of patients with severe dementia, debilitating psychiatric disorders or chronic renal failure requiring dialysis
IG (n=28):
  • Reassessment of therapeutic regime on the basis of telemonitoring and telephone contacts

  • Training course for patients and caregivers in the hospital to use equipment

CG (n=29):
  • similar course in the hospital on the importance of adherence

unclear/
unclear/
high/
low/ low/
low
Adherence to prescribed treatment: 12-months: 89.7 vs. 35.7% Intervention can improve the composite endpoint of mortality and hospitalization and medication adherence (RD 0.47; 95%CI 0.25 to 0.70), but not mortality and quality of life.
Brotons
2009
(e9)
RCT
Spain
01/2004
to
09/2005
283 hospitalized HF patients
76±8 years, 45% male
NYHA 49/45/5/1%
Diabetes: 42%
Hypertension: 76%

Exclusion of patients with a cognitive deficit
IG (n=144):
  • patient education in the hospital, booklet

  • monthly visits for one year (education, assessment of adherence to prescribed medications and lifestyle habits)

  • Nurses contacted the family physician or cardiologist when necessary

  • Contact per telephone every 15 days to evaluate clinical status by nurses

CG (n=139):
  • referral to family physician and/or cardiologist

low/ low/
high/
low/ low/
low
Adherence to pharmacological treatment (high scores are better)
12-months: 86.1 vs. 75.5%.
Intervention can reduce mortality and hospital readmissions, improve QoL and medication adherence (RD 0.11; 95%CI 0.01 to 0.21).
Galbreath
2004
(e11)
RCT
USA
1999 to
2003
1069 patients with HF symptoms identified through lists from partner institutions
71±10 years, 71%
male
NYHA: 19/57/21/3%
Diabetes: 28%
Hypertension: 72%
Hyperlipidemia: 50%
IG (n=710):
  • Assignment of a disease manager and a specialized cardiac nurses

  • Telephone administration of a DM program (first weekly, later monthly over 18 months)

  • Mailed educational material

  • smoking cessation instructions

  • For instable patients contact to a nurse

  • Fax with a call summary to the primary physician

  • toll-free telephone number

CG (n=359):
  • usual care by their physicians

unclear/
unclear/
unclear/
unclear/
low/ low
Adherence to
guideline-based
medications in systolic
HF patients
18-months: 54.4 vs.
43.3%
Intervention can decrease mortality, but not event-free survival and improve longtime medication adherence (RD 0.11; 95%CI 0.03 to 0.19). -
GESICA
2005
(e12)
RCT
Argentin
a
06/2000
to
11/2001
1518 ambulatory
stable HF patients
65±13 years, 71%
male
NYHA III-IV: 49%
Diabetes: 21%
Hypertension:59%
Exclusion of patients
with primary
pulmonary
hypertension
IG (n=760):
  • education booklet

  • telephone follow-up by trained HF nurses (14-day frequency, later according to the needs over 12 months) with monitoring and education

  • nurses could adjust doses of diuretic or recommend non-scheduled medical or emergency visits

CG (n=758):
  • followed by their attending cardiologist

low/ low/
unclear/
low/
high/
low
Adherence to
medication and diet (mean follow-up of 16 months):
beta-blocker: 59 vs. 52%
spironolactone: 27 vs. 23%
digoxin: 33 vs. 29%
furosemide: 77 vs. 70%
ACE-inhibitors: 78 vs.6%
Drug stop: 8 vs. 18%. dietary transgressions: 20 vs. 65%
Intervention can decrease mortality, readmissions and the probability of worsening HF and improve QoL and medication adherence (no drug stops of any drugs: RD 0.10; 95%CI 0.07 to 0.14 and diet: RD 0.45; 95%CI 0.40 to 0.49).
Sadik
2005
(e6)
RCT
United
Arab
Emirate
s
221 HF patients from general medical wards and from cardiology and medical outpatient clinics
59 years, 50% male NYHA: 30/50/16/4% Diabetes: 18% Hypertension: 23%
Exclusion of patients with low cognitive status
IG (n=109):
  • rationalization of therapy or simplification of dosage regimes by a research pharmacist and the physician

  • patient education, booklet

  • instructions on a self-monitoring program with a monitoring diary card

  • Discussion of the program by the research pharmacist and patient’s physician

CG (n=112):
  • usual care

low/
unclear/
high/
low/ low/
low
Compliance with the prescribed medicines: 12-months: 82 vs. 34%
Lifestyle advice:
baseline: 21 vs. 22%
12-months: 72 vs. 28%
Intervention can improve QoL and compliance to medications (RD 0.48; 95%CI 0.36 to 0.60) and lifestyle adjustments (RD 0.44; 95%CI 0.32 to 0.56) with no influence on mortality.
Wu
2012
(e5)
RCT
USA
82 HF ambulatory and hospitalized patients
60±13 years, 57%
male
NYHA I-II/III-IV:
51/49%
Charlson comorbidity
index: 3.1±1.9
Exclusion of patients with impaired cognition
IG (n=54):
  • education of major caregiver s and patients by a cardiovascular nurse expert (weekly, 4 dates)

  • intensive group (n=27): additional feedback to medication-taking behavior

CG (n=28):
  • usual care

unclear/
unclear/
low/
unclear/
low/
high
Medication taking
adherence:
baseline: 70 vs. 59 vs.
64%
9-months: 74 vs. 65
vs. 36%
Intervention improved eventfree survival, hospitalization, but not mortality and QoL. Intervention can improve adherence in both intervention groups (RD 0.38; 95%CI 0.14 to 0.63 and RD 0.29; 95%CI 0.03 to 0.54).

CG, Control group; CI, confidence interval; DM, disease management; HF, heart failure; IG, intervention group; n, number of randomized participants; NYHA, New York

Heart Association; QoL, Quality of life; RD, risk difference; RCT, randomized control trial;

RD>0 describe better adherence in IG

Risk of bias: I, random sequence generation; II, allocation concealment, III, blinding of outcome assessment; IV, incomplete outcome data; V: selective reporting; VI: otherbias

eTabelle 4. Studies with improved adherence to self-care management and improved clinical outcomes in the intervention group.

Article Study type recruit ment Population number, age, male, NYHA (I/II/III/IV), comorbidities Comparison Intervention (IG) vs. control (CG) Risk of bias (I/II/III/IV /V/VI) Patient adherence (measurement, follow-up) IG vs. CG Conclusions on primary outcome, clinical outcomes and patient’s adherence
Benatar
2003
(e51)
RCT
USA
04/1997
to
07/2000
216 hospitalized CHF
patients 63±13 years, 37% male NYHA III or IV Diabetes: 23% Hypertension: 94%
Exclusion of patients with renal failure or severe dementia or another debilitating psychiatric disorder
IG (n=108):
  • telephonic home monitoring devices to measured weight, blood pressure, heart rate, and oxygen saturation level with daily data transmission

  • an individual medical plan were developed by physicians and implemented by nurses

  • nurse evaluates patients’ data, titrates medication therapies and educated patients to achieve the goals


CG (n=108):
  • Home nurse visits

unclear/
unclear/
high/
low/ low/
low
Self-efficacy (higher scores are better):
baseline: 32.0±3.1 vs.
31.0±4.5
3-months: 35.9±2.7 vs.
32.7±3.5
Intervention can decrease HF readmissions, length of hospital stay, costs and improve QoL and self-efficacy (MD 3.16; 95%CI 2.32 to 4.00).
Bocchi

2008
(e50)
RCT
Brasilia
10/1999
to
01/2005
350 ambulatory CHF patients
51±17 years, 69% male NYHA 21/40/27/12% Diabetes: 17%
Exclusion of patients with severe renal diseae
IG (n=223):
  • DMP delivered by nurses, cardiologists, pharmacists, social workers, dietitians, dentists, psychologists)

  • Face-to-face individual/group communication

  • Educations for patients and caregivers (4x in the first 6 months, repetitive at 6-months intervals)

  • Telephone in-person communication by HF-nurses (14-day frequency)

CG (n=117):
  • usual care (standard follow-up by cardiologists)

low/ low/

low/ low/
low/ low
Adherence (higher scores are better):
baseline: 30.8 ±11 vs. 36.4 ±9.9
up to 6 (mean 2.5±1.7) years: 51.8 ±5.8 vs. 39.9 ±7.9
Intervention can reduce unplanned hospitalization, hospital days, emergency care, mortality and improve QoL and self-care-adherence (MD 11.9; 95%CI 10.3 to 13.5).
Brandon
2009
(e28)
RCT
USA
20 HF patients
60 (49 to 69) years, 45% male
NYHA 25/50/20/5%
IG (n=10):
  • 7 telephone appointments (every 2 weeks) with patient education by an advanced practice nurse

CG (n=10)
  • Usual care from the cardiologist clinic including education

unclear/
unclear/
unclear/
low/
unclear/
high
Self-care over the last 3 months (higher scores are better):
Baseline: 95.9 vs. 94 6-months (3-months after the intervention): 128 vs. 94 (p<0.001).
Intervention can decrease hospital admissions and improve QoL and self-care behavior (MD 34).
Dansky
2009
(e54)
RCT
USA
started
in
01/2006
108 CHF patients, discharged from Medicare-certified homehealth agencies
78 (22-98) years
Use of a telehealth-based disease management system in the hospital
IG (n=64):
  • use of the telehealth system under supervision of medicare-certified home health agencies over 6 months following discharge from formal health services

CG (n=44):
  • No further telehealth or home health services

unclear/
unclear/
high/
high/
unclear/

high
Self-management (weight control):
6-months: 86.7% vs. 50%
Intervention can decrease hospitalizations and emergency department visits and improve QoL. It can increase the frequency of patients who measured daily their weight (RD 0.37; 95% CI 0.17 to 0.57)
DeWalt
2006
(e52)
RCT
USA
11/2001
to
04/2003
127 HF patients from the General Internal Medicine and Cardiology Practices at a university hospital
62±10 years, 49% male NYHA: 0/50/46/4 Diabetes: 55% Hypertension: 88%
Exclusion of patients with dementia or on dialysis
IG (n=62):
  • Delivered in the General Internal Medicine Practice

  • Educational session (1-hour) with a clinical pharmacist or a health educator on the basis of an educational booklet for low literacy patients

  • Self-management of weight fluctuations and diuretic dosages

  • Scheduled follow-up telephone calls (days 3,7,14,21,28,56, monthly during months 3-6) with feedback to reinforce the educational session

CG (n=65):
  • General HF education pamphlet

low/ low/
high/
low/ low/
high
HF self-efficacy (higher scores are better):
12 months: MD 2 (95%CI 0.7 to 3.1)
Daily weighting: 79 vs. 29%.
Intervention can decrease hospitalization or deaths with no influence on mortality and QoL. It can improve selfefficacy and the frequency of daily weighting (RD 0.50; 95%CI 0.34 to 0.66).
Kasper
2002
(e2)
RCT
USA
12/1996
to
12/1998
200 hospitalized CHF patients at high risk of hospital readmission
62±14 years, 60% male NYHA II/III: 36/58% Diabetes: 40% Hypertension: 67%
Exclusion of patients with psychiatric disease or dementia
IG (n=102):
  • Telephone calls (within 72 h of hospital discharge, weekly, later monthly over 6 months)

  • Monthly follow-up visits with the CHF nurse: adjusted medication under the direction of CHF cardiologists, recommendation of a sodiumrestricted diet, exercise to walk

  • Individualized treatment plans

  • Weekly meeting of nurses and cardiologists

  • Financial support of patients on diet, transportation or telephone

  • Patients were supplied a pill sorter, a list of correct medications, a list of lifestyle recommendations, a contact number and educational material


CG (n=98):
  • Usual care by primary physicians

low/ low/
high/
low/ low
/low
Good or average compliance with dietary recommendations: 6-months: 69 vs. 45%, Medication compliance: no differences (not shown) Intervention might reduce readmissions and mortality. It can improve QoL and compliance to dietary recommendations RD 0.24; 95%CI 0.10 to 0.39), but did not influence medication compliance. -
Korajkic
2011
(e53)
RCT
Australia
02/2008
to
10/2008
70 HF patients presenting at a referral outpatient clinic
57±12 years, 77% male
NYHA: 0/72/27/1%
Diabetes: 16%
Hypertension: 44%
Hypercholesterinaemia: 51%
Exclusion of patients with baseline renal impairement (serum creatinine concentration > 200 μmol/L or on dialysis), severe psychiatric illness or moderate to severe dementia
IG (n=35):
  • Educational session during the clinic appointment with a pharmacist (30 min) to use instructions to daily assess symptoms of fluid retention, weight change and adjust frusemide dose

  • Self-adjustment of diuretic doses


CG (n=35):
  • No self-adjustment, patient called a HF nurse to discuss diuretic doses

low/
unclear/
low/ low/
low/ low
patients with appropriate weight-titrated furosemide dose adjustments:
3-months: 80% vs. 51%
The intervention can improve the ability of HF patients to self-adjust their diuretic dose by a flexible dosing regime (RD 0.29; 95% CI 0.07-0.50) and might reduce readmissions and QoL.
Shao
2013
(e30)
RCT
Taiwan
10/2006
to
01/2007
108 hospitalized CHF patients
72±6 years, 68% male NYHA: 7/66/27/0% number of co-morbidities: 3.8±0.8
Exclusion of patients with renal failure or debilitating psychiatric disorder
IG (n=54):
  • Designed to enhance selfmanagement by

  • Home visits within 3 days after enrolment

  • Telephone follow-ups at 1,3,7, and 11 weeks

  • Dairy of daily sodium and fluid intake and self-recording of weight

CG (n=54):
  • Usual care from clinical nurses during the patient’s hospital admission with education, differing telephone calls (at 3, 7 und 11 weeks) from the research assistant

low/ low/
high/
low/ low/
low
Self-efficacy for salt and fluid control (higher scores are better):
baseline: 41.6±10.2 vs.
43.6±10.3
3-months: 50.8±5.4 vs.
42.9±8.1
Self-care (modified EHFscBS):
baseline: 29.2±3.7 vs.
29.2±3.3
3-months: 27.1±2.5 vs.
30.1±1.7
Intervention can improve selfefficacy for salt and fluid control (MD 7.9; 95%CI 5.1 to 10.7), self-care (MD 3.0; 95%CI 2.1 to 3.9) and HFrelated symptoms.
Strömberg
2003
(e380)
RCT
Sweden
06/1997
to
12/1999
106 hospitalized HF patients
78±7 years, 61 % male
NYHA: 0/18/71/11%
Diabetes: 24%
Hypertension: 40%

Exclusion of patients with dementia or other psychiatric illness
IG (n=52):
  • Follow-up at a nurse-led HF clinic staffed by specially educated experienced cardiac nurses

  • First visit 2-3 weeks after discharge, visits lasted 1 h

  • Nurses evaluated status, individualized education about HF and self-care

  • social support to patients and their families

  • If treatment needed optimized, cardiologist was consulted and changed treatment

  • Patients could contact nurses during daily telephone hour

CG (n=54):
  • Conventional follow-up in primary health care

low/ low/
high/
high/
low/
high
Self-care change from baseline to 12 months follow-up (higher scores are better): 2.3 vs. 0.5 (p=0.01) - Follow-up in a nurseled HF clinic can improve survival, reduce hospital admissions and improve selfcare (MD 1.6; 95%CI 1.2 to 2.0).
Wierzcho
wiecki
2006
(e39)
RCT
Poland
160 hospitalized CHF patients
68±10 years, 59% male
NYHA: 0/14/47/39%
Diabetes: 28%
Hypertension: 48%
IG (n=80):
  • Multidisciplinary care on followup visits at the HF- clinic (after 14 days, 1,3,6, 12 months) by the cardiologist, the HF nurse, a physiotherapist and psychologist

  • Opportunity of telephone counselling by the HF nurse and cardiologist

CG (n=80):
  • Usual care by their primary care physicians

unclear/
unclear/
high/
unclear/
low/
high
Self-care (EHFscBS):
12-months (lower scores are better): 19.5 (IQR 16 to 24) vs. 42 (IQR 37 to 47) (p<0.001)
Intervention can decrease the frequency of readmissions, length of hospital stay, mortality, improve QoL and self-care (MD 22.2).
Wright
2003
(e55, e60)
RCT
New Zealand
1996 to
1997
197 hospitalized HF patients due to first diagnosis or exacerbation
73±11 years, 60% male
NYHA I-II/III : 93/7%
Diabetes: 29%
Treated hypertension: 52%
IG (n=100):
  • Out-patient clinical review (within 2 weeks of discharge followed by 6-weekly visits over 12 months) with

  • One-on-one patient counselling and education by specialized HF nurses

  • ptimization of medical therapy by a HF physician

  • Liaison with the patient’s family and the primary health care providers

  • HF diary to monitor and manage weight changes on the basis of an individualized action plan

  • Three group education sessions


CG (n=97):
  • Usual post-discharge care (mainly by as-needed primarycare consultations)

low/
unclear/
high/
low/ low/
low
Self-weighting:
12 months: 87 vs. 29%
Intervention had no influence on the combined endpoint of hospital readmission and death despite improved QoL and slightly lower mortality. It increased number of patients who used self-weighting (RD 0.29; 95%CI 0.03 to 0.54).

CG, Control group; CI, confidence interval; DM, disease management; EHFscBS, European Heart Failure Self-care behavior scale; HF, heart failure; IG, intervention group; IQR: inter-quartile-range; n, number of randomized participants; MD: mean difference; NYHA, New York Heart Association; QoL, Quality of life; RD, risk difference; RCT, randomized control trial;

MD, RD>0 describe better adherence in IG

Risk of bias: I, random sequence generation; II, allocation concealment, III, blinding of outcome assessment; IV, incomplete outcome data; V: selective reporting; VI: other bias

eFigure 3.

eFigure 3

Forest plot of the efficacy of interventions with improved adherence on mortality within 12 months.

I2, heterogeneity

CI, confidence interval

No, number of patients

RD, risk difference

eFigure 4.

eFigure 4

Forest plot of the efficacy of interventions with improved adherence on frequency of hospital inpatient admissions within 12 months.

I2, heterogeneity

CI, confidence

interval

No, number of

patients

RD, risk difference

eTabelle 5. Studies with no improvement of adherence and clinical outcomes in the intervention group.

Article Study type
recruit ment
Population number, age, male,
NYHA (I/II/III/IV), comorbidities
Comparison Intervention (IG) vs.
control (CG)
Risk of bias
(I/II/III/IV/
V/VI)
Patient adherence (measurement, follow-up) IG vs. CG Conclusions on primary outcome,
clinical outcomes and patient’s adherence
Agren
2010
(e36)
RCT
Sweden 01/2005
to
12/2008
155 recently discharged HF patients after a acute exacerbation
71±11 years, 75% male
NYHA: /32/53/15%
Diabetes: 12%
Hypertension: 34%
Exclusion of patients with dementia or severe psychiatric illnesses
IG (n=84):
  • Nurse-led face-to-face counseling,

  • Computer-based CD-ROM and other written teaching material

  • Education in the dyad’s home or in the HF-clinic (2, 6 and 12 weeks after discharge, duration >≥ 60 min)

CG (n=71):
  • Usual care without systematic involvement of the partner

low/ unclear/
high/
high/ low/
high
Self-care
(EHFscBS) change to baseline:
3-months: 3.1 ± 6.3
vs. 2.0 ± 6,9
12-months: 0.6 ±
8.2 vs. 1.3 ± 6.9
Intervention initially improved patients’ level of perceived control with no effect on long-term self-care (MD-0.70; 95%CI -2.03 to-3.43) and QoL.
Albert
2007
(e40)
RCT
USA
05/2000
to
07/2002
112 hospitalized HF patients after an acute
decompensation
60±14 years, 77% male Diabetes: 33%
Hypertension: 54%
Hyperlipidemia: 46%
Renal insufficiency:
34%
Exclusion of mentally not alert patients
IG (n=59):
  • Standard education and HF video on self-care behaviors and self-management (60 minutes)

CG (n=53):
  • Standard education by a variety of healthcare providers

high/ low/
high/ low/
unclear/
low
Self-care (SCHFI):
3-months: 2.6 vs.
2.2 (p=0.01)
Intervention did not influence healthcare utilization (including hospitalization) and the number of HFsymptoms, but it can improve self-care behavior (MD 0.4; 95%CI 0.1 to 0.7).
Arcand
2005
(e56)
RCT
Canada
47 stable HF patients from an ambulatory HF clinic
58±3 years, 74% male
Exclusion of patients with diabetes requiring insulin or severe renal dysfunction
IG (n=23):
  • Nutrition educational package

  • Nutrition education provided by dietitians at the hospital (two sessions over 30- 45 minutes)

CG (n=24):
  • Nutrition educational material

unclear/
unclear/
high/ low/
low/
unclear
Sodium intake
(g/d):
baseline: 2.80±1.47
vs. 3.00±1.52
3-months:
2.14±1.13 vs.

2.74±1.68
fluid intake
(1.88L/d):
baseline: 1.86±0.54 vs. 2.26±1.01
3-months:
1.88±0.64 vs.
2.02±0.72
Intervention might reduce sodium and fluid intake (MD 0.60; 95%CI -0.22 to 1.42 and 0.14; 95%CI -0.25 to 0.53).
Artinian
2003
(e27)
RCT
USA
18 scheduled HF patients
68±11 years, 94%
male
NYHA: 0/39/50/11%

Exclusion of patients with dementia, mental illnesses or hemodialysis
Educational booklet on HF self-care behavior
IG (n=9):
  • Usual care

  • Remind patients Med-eMonitor (retains a supply of up to 5 medications in individual compartments and uses an alarm to daily take the correct number of drugs)

  • Daily tailored reminders and questions about other medications and selfmanagement activities

  • Daily transmissions of patient’s information and changes of their regime to the MedeMonitor server

CG (n=9):
  • Usual care

  • Visits to the cardiologist in the HF clinic with assessment of medication-taking

low/
unclear/
high/ low/
high/
unclear
Self-Care (revised SCB):
baseline: 92±8 vs. 95±22
3-months: 106±21 vs. 108±22
compliance to daily weight monitoring:
3-months: 85 vs.
79%
blood pressure monitoring:
3-months: 81 vs.
51%
Intervention did not improve self-care behavior (MD -2; 95%CI -22 to 18) and might improve compliance to daily weighting (RD
0.08; 95%CI -0.30 to 0.45) and blood pressure monitoring with no influence on QoL.
Balk
2008
(e32)
RCT
Netherla nds
07/2005
to
08/2006
214 stable HF patients
66 (33-87) years,
70% male
NYHA 7 /41/50/2%
Diabetes: 31%
Hypertension 33%
IG (n=101):
  • Home TV-channel with education and reminders to medications in addition to follow-up by cardiologists

  • Patients with hospital admissions during the last year receive automatic devices for daily measurement of blood pressure and weight

  • Tele-guidance and monitoring of daily measurements by HFnurses on the basis of a personalized plan from the cardiologist

CG (n=113):
  • Follow-up by cardiologists and HF-nurses

unclear/
low/ high/
high/
high/ high
Self-Care
(EHFscBS):
no differences at the end of the study (mean follow-up 288 days, data not reported)
Intervention did not reduce mortality and the numbers of days in hospital and had no effect on QoL and selfcare behavior.
Barnason
2003
(e20)
RCT
USA
35 ischemic hospitalized HF CABG patients
73±5 years, 69%
male
NYHA I to II
IG (n=18):
  • Tele-medicine via the patient’s telephone for communication and assessment of symptoms, education and positive reinforcement and patient education

  • Patients had to respond to questions on their health status and CABG-recovery information (daily sessions for 6 weeks)

  • Research nurses reviewed responses to insure appropriate sessions

Control group (n=17):
  • Usual patient education and counselling prior to hospital discharge

unclear/
unclear/
high/
unclear/
unclear/
unclear
Cardiovascular
Risk Factor
Modification
Adherence (4=always adhere) at 3-months: exercise: 4.0±0.0 vs. 3.4±0.86 diet: 3.4±0.89 vs.
3.2±0.75 stress reduction:
4.0±0.0 vs. 3.3±0.77 medication use/ Tobacco cessation:
4.0±0.0 vs. 4.0±0.0 Summary score not reported
self-efficacy (higher scores are better): baseline: 43.2±9.5 vs. 43±6.4
3-months: 50.6±4.7 vs. 6.5±4.5
Intervention can improve self-efficacy (MD 4.10; 95%CI 3.37 to 4.83) and some components of QoL compared with usual care with no influence on lifestyle and medication adherence.
Bouvy
2003
(e1)
RCT
Netherla nds
07/1998
to
02/2000
152 HF patients in a hospital or attending a HF outpatient clinic
70±11 years, 66%
male
NYHA 10/42/44/4%
Diabetes: 28%
Hypertension: 40%
Renal Insufficiency:
13%
Exclusion of patients with dementia or severe psychiatric problems
IG (n=74):
  • Patient’s pharmacists received training for a structured interview on the patient’s first visit to the community pharmacy

  • Use of a computerized medication history for a discussion of drug use, reasons for non-compliance

  • General physician receives a summary of this interview

  • Monthly patient contact by the pharmacist (maximal 6 months)

CG (n= 78):
  • Usual care

low/
unclear/
low/ high/
low/ low
Medication compliance over the time (>95% compliance): up to 6 months: 87% vs. 63% Intervention can improve medication compliance (RD 0.25; 95%CI 0.07 to 0.42) with no influence on QoL, readmissions and mortality.
Bowles
2010
(e45)
RCT
USA
218 hospitalized HF patients
72±10 years, 36%
male
6.8±4 number of comorbidities
Exclusion of mentally not competent patients
IG:
  • Telehomecare in patients home (video phone, wireless peripheral devices)

  • Patients were allowed to measure alone, measurements readable for patients and transmitted directly to the home health nurse

  • Nurses and patients interacted via video phone (at least 4 visits were planned)

CG:
  • Usual care with skilled nursing visits per week (1-3 visits per week for up to 8 weeks depending on patient need)

unclear/
unclear/
low/ high/
high/
unclear
Self-care (SCHFI): 6-months:
maintenance: 57±4 to 72±19
management 48±26 to 64±24
Both groups improved self-care and reached adequate levels with no differences between groups. Intervention might reduce readmissions.
Boyne
2012 & 2014
e23, e24)
RCT
Netherla nds
10/2007
to
12/2008
382 scheduled HF patients
71±11 years, 59%
male
NYHA 0/57/40/3%
Exclusion of patients with hemodialysis or
(pre)dementia
IG (n=187):
  • telemonitoring with daily pre-set dialogues about symptoms, knowledge and behavior with automatic corrections between patients and nurses

  • responses were transferred into risk profiles (low, medium, high)

  • immediate response of the nurse on symptoms

  • after 3 months dialogues were adjusted to the current individual risk profile

CG (n=185):
  • nurse-led usual care including oral and written educational information and psychological support

low/
unclear/
high/
high/ low/
low
Self-care
(EHFscBS):
baseline: 18.9±5.3 vs. 20.9±6.1 12-months:
17.4±4.5 vs.
20.8±5.7
Self-efficacy: baseline: 53.2±7.1 vs. 51.1±9.6 12-months:
54.9±6.5 vs.
52.3±8.9
HF compliance scale at 12 months: medications: 93.5 vs. 89.8 weighting: 75.4 vs.
61.3 diet: 73.8 vs. 69.9 fluid: 76.5 vs.68.6 activities: 63.8 vs.
62.8 and appointments, smoking, alcohol
Intervention can increase mean time to first HF-related hospitalization and decrease number of hospitalization with no effect on mortality, can improve self-care (MD 3.4; 95%CI -4.6 to -2.2) and might improve selfefficacy (MD 1.18; p=0.192) and HF compliance.
Caldwell
2005
(e29)
RCT
USA
36 stable HF patients from a cardiology practice
71±15 years, 69%
male
NYHA I-IV
Exclusion of patients with a neurological disorder that impaired cognition
IG (n=20):
  • One-on-one education and counseling session by a noncardiac trained nurse

  • Phone-call at one month to reinforce education and symptom recognition

  • Written take-home information, weight dairy with a list of symptoms and actions

CG (n=16):
  • Usual care

  • Printed brochure on symptom recognition and selfmanagement

unclear/
unclear/
unclear/
low/
unclear/
high
Self-care
(abbreviated EHFscBS)
baseline: 1.6±0.9
vs. 1.5 ±0.8
3-months: 2.9±1.0
(better) vs. 1.9±1.3
Intervention can improve knowledge and self-care behavior (MD 1.0; 95%CI 0.05 to 1.93).
Copeland
2010
(e10)
RCT
USA 06/2005
to
12/2005
458 HF hospitalized or frequently treated ambulant patients from the Veterans
Health Administration
(VA)
70±11 years, 100%
male
Diabetes: 54%
Hypertension: 81%
Exclusion of patients with severe dementia or on dialysis
IG (n=220):
  • Creation of a patient-specific self-management plan using the primary care physician’s self-management plan

  • Scheduled telephone interactions including education and coaching by DM nurses to improve self-management (3040 min, frequency depending on risk profile)

  • Access to nurse advice line for symptoms and counselling (24 hours a day, 7 days a week)

  • Medication compliance and vaccination reminders, workbooks, post-assessment letters

  • Information of the patient’s physician about signs and symptoms of decompensation and non-adherence (fax, electronic medical record system)

Control group (n= 238):
Usual care
high/
unclear/
unclear/
high/
high/ low
Compliance to selfcare at 12 months: check weight daily:
OR 1.94; 95%CI 1.06 to 3.55
exercise: OR 1.94; 95%CI 1.08 to 3.49
recommended diet:
OR 1.29; 95%CI
0.72 to 2.29
medications: OR
0.59; 95%CI 0.20 to
1.73.
Intervention resulted in no differences in clinical outcomes (QoL, readmissions, mortality) with higher costs in the intervention group and improved compliance to
2 of 4 self-carerecommendations.
Domingues
2011
(e48)
RCT
Brasilia
01/2005
to
07/2008
120 hospitalized patients with
decompensated HF
63±13 years, 68%
male
Exclusion of patients with cognitive neurological sequelae
In-hospital nursing education (5 visits, 30-60 min) for patients and caregivers, weight chart
IG (n=57):
  • telephone monitoring after discharge over 3 months (8 calls) by a nurse to reinforce instructions and monitor symptoms

CG (n=63):
  • follow-up at the outpatient clinic

unclear/
unclear/
high/
high/ low/
low
HF awareness and self-care
knowledge score:
baseline: 4.6±1.9
vs. 4.5±1.9
3-months: 6.1±2.1
vs. 5.8±1.9
Intervention might improve awareness and self-care knowledge (MD 0.30; -0.55 to 1.15), but did not decrease mortality and hospitalizations.
Holland
2007
(e22)
RCT
United Kingdo m 12/2003
to
03/2005
339 hospitalized HF patients due to emergency issues
77±9 years, 63%
male
NYHA: 6/27/34/33%
IG (n=169):
  • Study pharmacists were provided with a copy of the patient’s discharge letter

  • Home visit of the pharmacist with the patient and any caregivers with education and advice (within 2 weeks and 6 to 8 weeks after discharge), booklet

  • Encouraged symptom monitoring diaries, removed discontinued drugs

  • Feedback to local pharmacist to the general practitioner and local pharmacist for a drug adherence aid

CG (n=170):
  • Usual care

low/ low/
high/
high/ low/
low
Drug adherence (MARS score):
baseline: 23.8 vs.
23.6
6-months: 23.7 vs.
23.6
Intervention had no effects on mortality, readmissions, QoL and medication adherence scores (MD 0.12; 95% CI -0.48 to 0.73).
Israel 2
013
(e16)
RCT
USA enrollme
nt
through
06/2012
732 CVD patients (108 with HF) admitted to the internal medicine, family medicine, cardiology or orthopedics service
≥18 years, 38% male
Hypertension: 75%
Hyperlipidemia: 61%
Exclusion of patients with dementia, cognitive impairment or severe psychiatric or psychosocial disorders
IG (n=486, 142 with HF):
  • Comprehensive medication reconciliations, identification of drug problems (within 24 hours of admission) by a pharmacy case managers

  • Recommendations to the inpatient care team and outpatient primary care physician to optimize therapy

  • Patient education (every one or two days during admission, on discharge)

  • Enhanced intervention group: discharge care plan was faxed to the patient’s primary care physician

  • Follow-up telephone call from the pharmacist to the patient (3 to 5 days after hospital discharge)

CG (n= 246, 66 with HF):
  • Usual care with discharge medication list and oral information from a hospital unit nurse

low/
unclear/
low/
unclear/
low/ high
Underutilization of
HF drugs
3-months:
ACEI or ARB: 17.1 vs. 29.7 vs. 30.6% β -blockers: 20.0 vs.
21.6 vs. 19.4%
Intervention had no effect on the underutilization of ACEI or ARB (enhanced IG vs. CG: RD 0.13; 95%CI -0.06 to 0.33, minimal IG vs. CG: RD 0.01; 95%CI -0.20 to 0.22) and β blockers (enhanced IG vs. CG: RD -0.01; 95%CI -0.19 to 0.18, minimal IG vs. CG: RD 0.02; 95%CI -0.21 to
0.16).
Jaarsma
2000
(e33)
RCT
Netherla nds
05/1994
to
03/1997
186 hospitalized HF patients
72±9 years, 60%
male
NYHA III/III-IV/IV:
17/22/61%
Diabetes: 32%
Hypertension:25%
Exclusion of patients with a psychiatric diagnosis
IG (n=89):
  • Intensive structured individualized education by a study nurse (approximately 4 visits in the hospital, 1 telephone call, 1 home visit)

  • Information of the home care nurse about specific needs

Control group (n=97):
  • Standard care and education

unclear/
unclear/
high/ low/
low/
unclear
Self-care (modified SCB scale):
baseline: 8.9±3.0 vs. 9.5±3.0
3-months: 11.6±3.1
vs. 10.2±3.3
9- months:
10.4±3.1 vs.
10.1±2.9.
Intervention can improve self-care behavior over a short time, but not over a longer follow-up (MD0.3; 95%CI -0.058 to -1.18), might be successful in improving QoL, but did not reduce mortality.
Jurgens
2013
(e41(e)
RCT
USA
105 HF patients admitted to the hospital, referred from community health care providers or recruited with advertisements
68±12 years, 68% male
NYHA I-II/III/IV: 15/48/37%
Exclusion of patients with major diagnosed psychiatric illness
Weight-scales, HF-self-care booklet written at the 6th to 8th grade level
IG (n=53):
  • Additional education on how to recognize and response to symptoms (4 times)

  • Home visit (7 to 10 days after discharge) to review symptom training

CG (n=52):
  • Usual care

low/
unclear/
unclear/
low/ low/
low
Self-Care (SCHFI) Maintenance: baseline 56.8±22.0 vs.57.5±24.0
3months:76.9±18.4 vs. 70.8±21.2
Management:
baseline: 48.2±19.3
vs. 43.8±21.1
3-months:
60.4±27.2
vs.61.1±22.5
Intervention had no influence on mortality, readmissions and selfcare management (MD 0.7; 95%CI -0.7; -10.6 to 9.1) and might improve self-care maintenance (MD 6.1; 95%CI -1.7 to 13.9).
LaPointe
2006
(e17)
c-RCT USA
01/2001
to
09/2001
45 medical practices with 2717 HF patients
69 years, 67% male
NYHA: 5/12/13/8%
Patients receive a 1-page summary of the evidence for beta-blocker use and a patient-oriented brochure for distribution
IG (n=23 practices with 1701 patients):
Additional patient education videotapes
Feedback on beta-blocker use
of their patients with HF
Provider internet education
Access to telephone communication with a HF expert
Control group (n=22 practices with 930 participants):
No further intervention
unclear/ unclear/ low/ high/ low/ high Mean proportion of patients taking β blocker within practices:
12-months: 66 vs.
63%
Intervention did not change the use of β blocker (RD 0.03;
95%CI -0.01 to 0.07).
Laramee 2003
(e21)
RCT
USA 07/1999
to
02/2001
287 hospitalized HF patients
71±12 years, 54%
male
NYHA: 16/43/33/2%
Diabetes: 43%
Hypertension: 74%
Hyperlipidemia: 57%
Exclusion of patients with cognitive impairment or longterm hemodialysis
IG (n= 141):
  • Intervention performed by the chronic HF case manager

  • Early discharge planning and coordination of care

  • Individualized and comprehensive patient and family education including a 15page HF booklet

  • Telephone follow-up and surveillance (1-3 days after discharge and at weeks 2,3,4,6,8,10,12)

  • Promotion of optimal HF medication and medication doses

CG (n=146):
  • Standard care in the hospital and follow-up by the patient’s own local physician

unclear/
unclear/
high/
high/ low/
low
Adherence scores: 3-months (higher better): daily weighting: 4.6 vs. 3.1, p<.001 check for edema:
4.8 vs. 4.6, p=.02 low salt diet: 4.8 vs. 4.4, p<0.001 fluid restrictions:
5.0 vs. 4.6, p=.003 medications: 5.0 vs. 4.9, p=.04 ACEIs or ARBs: 84 vs.
80% β -blocker: 70 vs.
62%
Intervention did not change readmission rates but may have improved adherence to some lifestyle recommendations and medications. -
López-
Cabezas
2006
(e13)
RCT
Spain
09/2000
to
08/2002
134 hospitalized HF patients
76±9 years, 44%
male
NYHA I-II/II-IV:
86/14%
Diabetes: 34%
Hypertension: 61%
Renal Failure: 32%
Exclusion of patients with any type of dementia or disabling psychiatric disease
IG (n=70):
  • Active information by a pharmacist

  • At hospital discharge: personal education of the patient and his caregiver

  • Telephone monitoring (monthly during 6 months, later every 2 months)

  • Contact telephone number of the pharmacist

CG (n=64):
Standard care
low/ low/
high/
high/
low/
unclear
Treatment compliance, reliable patients:
6-months: 91.1 vs.
69%
12-months: 85 vs.
73.9%
Intervention might reduce the number of new admissions and deaths and improve QoL. It can improve medication compliance with potential long-term differences (RD 0.11;
95%CI -0.01 to 0.32).
Luttik
2012
(e14)
RCT
(non-
inferiorit y trial)
Netherla nds
189 HF patients
visiting an outpatient HF clinic
73±11 years, 64%
male
NYHA III/III-IV/IV:
17/22/61%
Diabetes: 34%
Exclusion of patients with current psychiatric disorder
Optimal treatment and patient education in a outpatient HF clinic
IG (n=97):
Follow-up in primary care with no scheduled visits in the HF clinic over 12 months
CG (n=92):
Follow-up at a specialized HF clinic and care as usual over 12 months
unclear/
unclear/
low/ low/
high/ low
Patient adherence
over 12 months:
total score: 92.3 vs.
94.4%
ACE inhibitor/ARB: 93.5 vs.
95.2%
β -Blocker: 93.5 vs.
94.9%
MRA: 87.1 vs.
93.3%
Intervention shows non-inferiority in maintenance to guideline adherence and patient’s medication adherence (RD -0.02; 95%CI -0.11 to 0.07) and no differences in the number of deaths and readmissions.
Mejhert
2004
(e19)
RCT
Sweden 01/1996
to
12/1999
208 hospitalized HF patients
76±7 years, 58%
male
NYHA: 10/62/37/1%
Diabetes: 22%
Hypertension: 31%
Exclusion of patients with dementia
- IG (n=103):
  • Follow-up within a nursemonitored intervention program with

  • Nurse checks symptoms, changes doses of medications

  • Patient education on symptom monitoring, changes of diuretics, dietary advices

  • Repetition in booklets and computerized education programs

  • Written information to the general practitioner

Control group (n=105):
  • Follow-up by their general practitioners

unclear/
unclear/
unclear/
high/
high/ low
Goal doses of ACE:
18-months: 88 vs.
74%
Intervention had no favorable effect on QoL, mortality or readmission rate but can optimize medication adherence (RD 0.14; 95%CI 0.04 to 0.24).
-
Murray
2007
(e3)
RCT
USA
02/2001
to
06/2004
314 HF stable
ambulatory patients
62±8 years, 33%
male
NYHA: 19/41/35/5%
Diabetes: 65%
Hypertension: 96%
Exclusion of patients with dementia
- IG (n=122):
  • Pharmacy intervention on the basis of a baseline medication history

  • Patient education about medication (verbal and written) aimed at patients with low literacy

  • monitoring od patients’ medication use, health care encounters and body weight in a study database

  • as-needed communication with clinical nurses and primary care physicians

  • interdisciplinary team (pharmacist, geriatrician, cardiologist, behavioral scientist, psychologist)

CG (n=192):
  • prescription service from rotating pharmacists

low/ high/
low/ low/
low/ low
Adherence to medication:
intervention period:
78.8 vs. 67.9%
3-months postintervention period:
70.6 vs. 66.7%
Intervention can improve medication adherence during intervention period (MD 10.9; 95%CI 5.0 to 16.7). The benefit probably requires constant intervention because the effect dissipated in the postintervention period (MD 3.9; 95%CI -2.8 to 10.7). The intervention can reduce the number of all-cause readmission to the hospital or emergency department and slightly reduces mortality.
Mussi
2013
(e31)
RCT
Brazil
10/2009
to
11/2012
200 hospitalized HF patients due to decompensation
63±13 years, 63%
male
NYHA: 7/41/41/11%
Diabetes: 36%
Hypertension: 69%
Depression: 22%
- IG (n=101):
  • Systematic follow-up by HF nurses with home visits (10, 30, 60, 120 days after discharge) with physical examination and education

  • Four telephone contacts to reinforce education

CG (n=99):
  • Conventional follow-up

low/
unclear/
low/ high/
high/ low
Self-care
(EHFScBS):
baseline: 34.4±7.7
vs. 34.0±7.7
6-months: 22.4±6.5
(better) vs.
30.9±7.3
Correct answers to treatment adherence:
baseline: 46.3±16.2
vs. 45.2±16.4%
6-months:
71.2±13.8 vs.
55.0±15.0%
Intervention can improve knowledge on HF, selfcare (MD 8.5; 95%CI 6.3 to 10.8) and knowledge on treatment adherence (MD 14.8; MD 95%Ci 10.0 to 19.7) with no influence on mortality.
PetersKlimm
2010
(e37)
RCT German
y
06/2006
to
01/2007
199 ambulatory HF patients with former hospitalization from 31 physicians
70±10 years, 73%
male
NYHA: 3/66/30/1%
Diabetes: 34%
Hypertension: 79%
Depression: 20%
Dyslipidemia: 70%
- IG (n=99):
  • Case management by a trained doctor’s assistant with telephone monitoring (NYHA III-IV: 3-weekly, NYHA I-II: 6weekly) and three home visits for one year

  • Feedback from the assistants to the general physician

  • Patient leaflet, booklets and tailored diaries

Control group (n=100):
  • Usual care

low/ low/
high/
high/ low/
low
Self-care
(EHFscBS):
Baseline: 25.4±8.4
vs. 25.0±7.1
12-months:
21.2±6.4 vs.
24.8±6.7
Intervention had only small influence on QoL, mortality and readmissions, but can improve self-care (MD 3.6; 95%CI 1.6 to 5.7).
Powell
2010
(e15)
RCT
USA
10/2001
to
19/2004
902 ambulatory and hospitalized HF patients
64±14 years, 53%
male
NYHA II/ III: 68/32%
Diabetes: 40%
Hypertension: 75%
Major depressive symptoms: 29%
Exclusion of patients with psychiatric comorbid conditions
IG (n=451):
  • 18 group-base HF education by advanced trained health professionals (18x2h) over 12 months


CG (n=451):
Education by 18 HF tip sheets on the same schedule but delivered by mail and telephone contact to
answer questions
unclear/
low/ high/
low/ low/
low
Adherence to ACEI or BB therapy decreased over 12 months in both groups from 61.6 vs. 63.6% by 7 percent points
Self-efficacy improved in both groups by 0.2 points
Salt intake (≤2400 mg/d):
12-months: 28 vs.
18%.
The intervention did not reduce death or HF hospitalization, improve QoL, self-efficacy and drug adherence (OR 0.84; 95%CI 0.6 to 1.18) and can slightly reduce salt intake (RD 0.10; 95%CI 0.05 to 0.15).
Riegel
2004
(e42)
RCT
USA
1999
to
2001
88 hospitalized HF patients
73±13 years, 42%
male
NYHA: 5/32/44/19%
Diabetes: 46%
Hypertension: 82%
Exclusion of patients with cognitive impairment
- IG (n=45)
  • Training of 9 patients as mentors (5 classes taught over 2 weeks by specialized nurses) on self-care, monthly meetings of mentors and nurses

  • Each mentor was assigned to at least 1 mentee

  • Telephone calls, home visits, joint outings, demonstrations and modelling of mentors and mentees (after discharge from hospital, at least weekly in the 1rst month, monthly in months 2-3)

CG (n=43):
  • Usual care including in-patient education

low/
unclear/
high/
high/ low/
high
Self-care (SCHFI):
baseline:
147.4±38.7 vs.
175.3±36.1
3-months:
159.2±46.3 vs.
178.4±29.6
Maintenance:
baseline: 63.0±19.4
vs. 64.3±18.6
3-months:
74.5±18.3 vs.
68.9±15.6
Management:
baseline: 34.7±16.8
vs. 44.9±14.9
3-months:
38.0±18.2 vs.
46.4±17.7
Intervention increased readmissions and might improve self-care maintenance (MD 5.6; 95%CI -5.2 to 16.4). It was not able to improve final total self-care scores (MD -19.2: -40 to 1.6) and self-care management (MD -8.4; 95%CI -19.7 to 2.9) due to high baseline differences.
Rodriguez-
Gázquez
2012
(e34)
RCT
Columbi
a
2010
63 HF patients attending a CV health program at a hospital institution
68±11 years, 49%
male
NYHA I-III
(mean±SD): 2.2±0.7
Diabetes: 33%
Hypertension: 81%
Renal failure: 16%
Dyslipidemia: 16%
Depression: 3%
- IG (n=33):
  • Educational meeting for patients and their families (during the first month) Workshop on healthy cooking Telephone monitoring (monthly in months 2-7) or home visits (months 1,8) Educative folder during the first meeting

CG (n=30):
  • Standard care

  • Educational meeting and folder at the end of the study

low/ high/
high/ low/
low/ low
Adherence to pharmacological and nonpharmacological treatment (SCB): baseline: 40.0±6.2 vs. 43.4±5.7
9-months:
52.2±10.1 vs.
48.5±9.0
Intervention might improve self-care in patients with HF (MD 3.7; 95%CI -1.35 to 8.75) with no influence on mortality and hospitalization.
Ross
2004
(e25)

RCT
USA
09/2001
to
12/2001
107 HF patients
followed in a
specialty HF clinic
56 years, 77% male
- IG (n=54):
  • patients receive a user code and password to a web interface to three components: the medical record, an educational guide and a messaging system over 12 months

  • messaging system allows to exchange secure messages with the nursing staff

CG (n=53):
  • Standard care in the HF clinic

low/
unclear/
high/ low/
low/ low
General Adherence
at 12 months:
85 vs. 78, p=0.01
Medication
Adherence:
3.6 vs. 3.4, p=0.15
Intervention can improve general adherence (MD 6.4; 95%CI 1.8 to 10.9) and medication adherence (MD 0.2; 95%CI -0.1 to 0.6) with more emergency department visits in the IG and no influence on mortality and QoL.
Seto
2012
(e46)
RCT
Canada
09/2009
to
02/2010
100 ambulatory HF
patients at a HF
clinic
54±14 years, 79%
male
NYHA II/II-III/III/IV:
43/11/42/4%
- IG (n=50):
  • tele-monitoring with daily weight and blood pressure measurements and weekly single-led ECGs over 6 months

  • daily answers to symptom questions on a mobile phone

CG (n=50):
  • Usual care at the clinic with visits at the clinic depending on the severity of HF

low/
unclear/
high/
high/ low/
low
Self-care (SCHFI):
Maintenance:
baseline: 65.5±18.6
vs. 58.9±18.7
6months:73.3±11.6
vs. 65.5±15.8
Management:
baseline: 58.1±24.5
vs. 57.9±22.4
6-months:
68.6±16.0 vs.
69.3±18.3
Intervention can improve self-care maintenance (MD 7.8; 95%CI 1.8 to 13.8), but not self-care management (MD -0.7; 95%CI -11.5 to 10.1). It improved Qol, but not hospitalization, mortality and emergency care visits. .
Shearer
2007
(e43)
RCT
USA
winter
2001 to
fall 2003
90 hospitalized HF patients
76±8 years, 64%
male
NYHA:0/43/49/8%
- IG (n=45):
  • Telephone-delivered education by specialized nurses (1-3 days, 2,4,6,8,12 weeks after discharge)

CG (n=45):
  • Usual education on HF from a nurse in the hospital

unclear/
unclear/
high/ low/
low/ low
Self-Management
of HF: baseline:
16.4±2.5 vs. 17.0±
2.6
3-months: 19.6±2.2
vs. 18.0±3.0
Intervention had no influence on purposeful participation or QoL, but can improve selfmanagement of HF (MD 1.6; 95%CI 0.3 to 2.8).
Shively
2013
(e47)
RCT
USA
84 HF patients, hospitalized or emergency
department visit within the previous 12 months
66±11 years, 83%
male
NYHA (I /II/III):
4/33/52%
≥3 comorbid conditions: 71%
Exclusion of patients with psychiatric problems
- IG (n=43):
  • individualized intervention depending on the baseline activation level by advanced nurses with self-selected goals

  • 6 sessions with nurses by telephone or I person in 6 months

  • Self-management toolkit (blood pressure cuff, weight scale, pedometer, HF selfmanagement DVD, educational booklet)

CG (n=41):
  • Usual care at a primary care provider (physician, nurse practitioner or physician assistant)

low/
unclear/
high/
high/ low/
low
Self-care (SCHFI):
baseline: 56.7±17.5
vs. 64.7±20.7
6-months:
65.1±22.7 vs.
70.0±19.2
Intervention can improve patient activation selfmanagement selfconcept and adherence and may improve patients’ self-care. Hospitalization were improved in patients with low or high baseline activation level-
Smeulders
2009 & 2010 (e35, 58)
RCT
Netherla nds
10/2004
to
01/2006
317 HF patients with a limitation of physical activity
67±11 years, 73%
male
NYHA: 0/67/33/0%
- IG (n=186):
  • 6-week self-management group program by a HF-nurse (6 weekly sessions over 2.5 hours)

  • Telephone calls with coparticipants

  • HF reference book

CG (n=131):
  • Follow-up with the cardiologist and a HF-nurse

low/ low/
high/ low/
unclear/
high
Self-care
(EHFscBS):
baseline: 47.7±6.0
vs. 48.3±6.7
direct follow-up:
49.8±5.8 vs.
48.7±6.5
12-months:
49.2±6.3 vs.
49.2±6.6
Program can improve self-care behavior directly after the program (MD 1.5; 95%CI 0.4 to 2.5), but they did not achieved over 12 months (MD 0.9; 95%CI -2.2 to 0.35) with no influence on mortality and hospital admissions.
Strömberg
2006
(e49)
RCT
Sweden
154 HF patients visiting a nurse-led HF clinic
70±10 years, 71 %
male
Individualized patient education from a HF-nurse during a follow-up visit in a nurse-led HF-clinic (1 hour)
IG (n=82):
  • additional interactive multimedia program with selftest (30-45 min)

CG (n=72):
  • no additional computer-based education

low/
unclear/
low/ low/
low/ high
Compliance with treatment and selfcare:
baseline: 11.88 vs.
11.89
mean change over
6 months: -0.21 vs.
0.09 (p=0.09)
Intervention can improve knowledge, but not compliance, QoL and mortality.
Thompson
2005
(e26)
c-RCT
UK
106 hospitalized HF patients
73±13 years, 73 %
male
NYHA III: 75%
Charlson comorbidity
index: 2.5±1.4
Diabetes: 20%
IG (n=58):
  • Primarily applied by two experienced HF nurses

  • Patient education in the hospital

  • Home visit with education and clinical examination (within 10 weeks after discharge)

  • Contact number

  • Visits in a nurse-led outpatient HF clinic (monthly) with education and examinations and recommendation of new therapeutic agents

CG (n=48):
  • Standard care with short explanations by the ward nurse and outpatient appointment 6-8 weeks after discharge

low/
unclear/
high/
unclear/
low/ low
Treatment adherence: few differences at 6 months (not reported).
Na restricted diet:
8.9±2.3 vs. 7.3±1.9
(better in IG)
Intervention slightly decreased risk of death or readmissions and QoL with slight difference in general adherence and Na restricted diet (MD 1.6; 95%CI 0.75 to 2.34).
Tsuyuki
2004
(e18)
RCT
Canada
09/1999
to
04/2000
276 hospitalized HF patients
72±12 years, 58 %
male
NYHA: 13/50/33/4%
IG (n=140):
  • Before discharge: one-to-one education on the basis of a written educational package

  • Adherence aids (medication organizer, administration schedule, daily weight log)

  • Telephone contact (2, 4 weeks after discharge, later monthly over 6 months) to reinforce education

  • Monthly newsletter

CG (n=136):
  • General HF pamphlet. usual care

low/ low/
low/ low/
low/ low
ACE inhibitor adherence: over 6 months: 83.5±29 vs. 86.2±29%. Intervention did not improve ACE inhibitor use (MD -2.7; 95%CI 9.5 to 4.1), but might reduce CVD-related emergency room visits.
Wakefield
2008 & 2009
(e4, e59)
RCT
USA
07/2002
to
09/2005
148 hospitalized HF patients due to exacerbation
69±10 years, 99 %
male
NYHA: 0/28/65/7%
IG (n=99):
  • Telephone contact by nurses (three times in the first week after discharge, weekly for 11 weeks) to assess symptoms

  • Patients received a symptom review checklist, a scale, blood pressure cuff, tape measure,

  • Patient education

  • Nurses reinforced the plan for care, made referrals or contacted physicians and employed strategies to improve compliance to treatment plans and encouraged selfmanagement

CG (n= 49):
  • Contact to primary care nurse if needed

unclear/
low/ high/
low/ high/
low
Compliance scores: 3-months: 88 (both intervention groups) vs. 91%
6-months: 86 vs.
91%
Self-efficacy to manage disease: 6-months: 6.2±2.0 vs. 7.1±2.2 vs. 7.2±2.0
to manage symptoms: 6-months: 6.0±2.3 vs. 5.8±2.4 vs.
6.2±2.5
Intervention can decrease readmission in both intervention groups with no differences between these groups, higher mortality in the videophone group and no differences in QoL. It shows no long-term differences in
compliance (RD -0.05; 0.18 to 0.08), selfefficacy to manage disease (MD -0.5; 95%CI -1.4 to 0.4) and symptoms (MD -0.3; 95%CI -1.3 to 0.7).
Welsh
2013
(e57)
RCT
USA
52 HF patients from a cardiologic clinic, community and university hospital
62±10 years, 54 %
male
NYHA II/III-IV: 48 /
52%
Exclusion of patients with cognitive disorders or the presence of a major psychiatric disorder other than depression
- IG (n=27):
  • Dietary individualized education on low-sodium adherence by home visits or phone calls (weekly over 6 weeks)

CG (n=25):
  • Usual care

low/
unclear/
high/ low/
low/ low
Self-care management of a low sodium diet: dietary sodium intake:
6-months: 2262
±925 vs. 3164 ±886
(p=0.011)
Intervention can decrease dietary sodium intake (MD 901; 95%CI 410 to 1390).
Zamanzadeh
2013
(e44)
RCT
Iran
07/2011
to
09/2011
80 hospitalized HF patients
64±11 years, 54%
male
NYHA III/IV : 48/52%
Hypertension: 36%
Exclusion of patients with mental illness
IG (n=40):
  • Customized education (onehour) in the hospital by a nurse with a booklet for the patient and family members

  • Post-discharge telephone follow-up (every two weeks over 3 months) by a nurse

  • Contact number of the nurse

CG (n=40):
  • Usual care provided by the hospital and the attending physician

low/
unclear/
high/ low/
low/ low
Self-care (SCHFI):
Maintenance:
baseline: 18.5±12
vs. 21.9±14.6
3-months:
75.1±20.7 vs.
31.9±15.5
Management:
baseline: 11.9
±11.9 vs. 16.7±16.7
3-months:
66.5±15.3 vs.
30.3±17.6
Intervention can improve self-care behavior in self-care maintenance (MD 43.2; 95%CI 35.1 to 51.3) and management (MD 36.2; 95%CI 28.9 to 43.5).

CG, Control group; CI, confidence interval; c-RCT, cluster randomized control trial; CVD, cardiovascular disease; DMP, disease management program; EHFscBS, European Heart Failure Self-care behavior scale; HF, heart failure; IG, intervention group; n, number of randomized participants; NYHA, New York Heart Association; MD, mean difference; OR, Odds Ratio; QoL, Quality of life; RD, risk difference; RCT, randomized control trial; SCB, self-care behavior; SCHFI, Self-Care of Heart failure index;

MD, OR, RD>0 describe better adherence in IG

Risk of bias: I, random sequence generation; II, allocation concealment, III, blinding of outcome assessment; IV, incomplete outcome data; V: selective reporting; VI: other bias

Discussion

Adherence to medication treatment as well as adherence to accompanying lifestyle recommendations can be improved by means of appropriate interventions. The effect sizes we found were lower than assumed, not least because of the pronounced heterogeneity of the included studies. Sustained effects can be expected especially for multimodal approaches that are provided with interactive feedback options for longer time periods.

Improved adherence to medication treatment

Approaches that entailed, among others, maintaining contact with patients for a lengthy period of time in order to practice adherent behaviors and check these were particularly effective (eTable 3). Notably, such sustained effects were usually achieved independently of medical doctors—for example, by specially trained nursing staff, doctors’ assistants (2630), or pharmacists (29).

Moderately positive, but long-term, effects on quality of life, adherence to medication therapy, and self-care were shown as a result of complex bundles of measures (simplified dosing regimen, education for patients, brochures, keeping a heart failure diary with discussion of the documented entries) (29). Similarly, bundled interventions (telephone monitoring, smoking cessation courses, home visits in instability, advisory hotline) (27) had a positive effect on adherence to medication treatments and on mortality. The large GESICA study (which included 1518 patients) (28) showed that combined interventions had a sustained moderate success (telephone monitoring, information brochure, patient education provided by nursing staff, and recommendations on adjusting medications and emergency admissions).

By contrast, no sustained effects were seen for approaches whose main focus was on educational/training measures in hospital and included only very few contacts with patients for the extended observation period (for example, e3, e16, e49).

Our results therefore confirm the results of other review articles on the adherence to medication treatment: the long-term use of complex patient centered interventions is required for the intervention to be successful. However, this does not reach all patients, with the result that altogether the effects on adherence and clinically important endpoints are rather small (31, 32).

Improved adherence to lifestyle modifications

We estimated the efficacy of interventions to improve adherence to lifestyle modifications in studies with very heterogeneous endpoints; summarizing the results is therefore difficult. What seems promising, however, is multidisciplinary cooperation with a combination of inpatient and outpatient care (eTable 4). This should include primarily patient education/training with individual treatment planning in hospital and subsequent regular outpatient contact, with repeated training sessions, medical histories, and examinations provided by non-doctor medical professionals (3335). The efficacy of such measures can be supported by further interventions, such as:

  • Care provided in a special clinic run by nursing staff (35)

  • Structured telephone contact

  • Medication adjustment by nursing staff after discussion with cardiologists

  • Psychosocial care

  • Help provided in a patient’s domestic environment

  • Creating a therapeutic bond that is based on trust.

Some studies (e33, e36) showed improved self-care at first follow-up, but they did now show any sustained improvements in results beyond the duration of the intervention. The therapeutic bond with a trusted professional—whether by telephone contact or home visit, or in the setting of a training/educational measure—obviously has a crucial role in improving adherence. A merely technically based solution without human interaction seems neither immediately effective nor able to provide a sustained effect (e23). In another study (e42) patients in the intervention groups were trained up as mentors, who were available to a particular assigned patient personally or by telephone whenever required. Although the implementation was linked to a person, self-care did not notably improve. The possible reason may be in the lack of competence that is perceived in a patient mentor—by contrast to medical personnel, encounters with whom a priori inspire a greater amount of confidence.

The efficacy of the collaboration of acute hospitals and rehabilitation facilities, and the formation of multidisciplinary networks in tertiary prevention of cardiovascular disorders was also emphasized by Labrunée et al (36).

Effect on clinical outcomes

The present review found that improved adherence was associated with additional positive effects on clinically relevant outcomes, which range from improved quality of life to reduced hospital stays to lower mortality. Further review articles have shown the lack of efficacy of patient training alone on clinical outcomes (37) and have shown the need for further patient centered measures in a patient’s domestic environment, such as structured telephone contacts and telemonitoring (38), or multidisciplinary care (39).

Limitations

One of the limitations of this study is the fact that on the one hand, certain groups—such as patients with depression or dementia syndromes—in whom the risk for lower adherence is particularly great, were excluded from many studies. On the other hand, the studies are probably representative for the group of patients requiring treatment with regard to age and disease severity.

This review includes exclusively strategies for the implementation of measures recommended these days, as the literature search was restricted to the time period starting after the year 2000. A bias to the observed treatment effects by selective publication of positive effects of the intervention on adherence cannot be excluded, especially in studies with primary clinical endpoints. The extensive heterogeneity of the described studies and the lack of objectivity in capturing adherence with the resulting heterogeneous treatment effects should be seen as a critical issue, so that the main result of this review is not the pooled treatment effects but the presentation and discussion of effective interventions.

Conclusion

In the practical implementation of adherence-promoting packages of measures, specialized nursing staff in hospitals, and specially trained doctors’ assistants working in doctors’ private practices are likely to have a crucial part in establishing such measures in a patient-centered way in future. Active participation of patients in the context of shared decision making (40) should form the basis for deciding on individual measures aiming to improve adherence. To this end, patients should be enabled—on the basis of comprehensible, evidence-based information tailored to them—to develop realistic expectations of their own disease course, and to be active and adopt individual responsibility in terms of dealing with their disease and treatment measures.

Key Messages.

  • This systematic review investigates the efficacy of interventions on adherence to medication therapies and implementation of lifestyle recommendations in patients with heart failure, and how clinical endpoints improve as a result

  • Adherence to medication therapies improved in 14 of 24 studies; the proportion of non-adherent patients was lowered by 10 percentage points (95% confidence interval [5; 15]).

  • Adherence to lifestyle recommendations improved in 31 of 42 studies.

  • Improved adherence in at least one guideline recommendation reduced in the long term the risk of death or inpatient stays in hospital by 2 and 10 percentage points, respectively.

  • Improved adherence requires patients’ activity and responsibility in dealing with their disorder and treatment measures. Especially patients with cognitive impairments benefit from additional support provided by specialized nursing staff or doctors’ assistants.

Acknowledgments

Translated from the original German by Birte Twisselmann, PhD.

The authors thank Professor Dr. med. Andreas Klement for his commitment to supervising the entire project.

Footnotes

Conflict of interest statement

The authors declare that no conflict of interest exists.

References

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