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. 2016 Jun 24;113(25):423–430. doi: 10.3238/arztebl.2016.0423

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