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

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