N/A N=258 Randomized Single-blind Supportive Care

Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure

Chronic Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT01692119 ↗

Enrolled (actual)

258

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Medication Adherence — 91.2; 85.5 percentage of days covered

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Regular, pharmacy based intervention (Behavioral)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Federal Union of German Associations of Pharmacists
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Medication Adherence	91.2; 85.5	—
PRIMARY Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause	24.8; 16.5	—

Summary

The aim of the study is to investigate whether a continuous interdisciplinary intervention improves medication adherence (primary efficacy endpoint) and leads to a reduction of hospitalizations and mortality (primary safety endpoint) in elderly patients with chronic heart failure. The intervention, consisting of regular contacts with the local pharmacy and weekly dosing aids, aims to improve medication adherence and management.

Eligibility Criteria

Inclusion Criteria

Age: 60 years and older
Chronic heart failure (CHF)
Stable CHF medication including a diuretic
Hospitalization for decompensated heart failure within past 12 months OR a value of ≥ 350 pg/mL for BNP or ≥ 1,400 pg/mL for NT-proBNP
Written informed consent

Exclusion Criteria

Use of a weekly dosing aid
Unwillingness or inability to visit a participating pharmacy once a week
Planned cardiac surgery
Life-expectancy < 6 months
Unwillingness or inability to comply with the study protocol (including drug abuse or alcohol dependency)
Participation in other studies (currently or in the last 4 weeks)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01692119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.