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

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