Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure (PHARM-CHF): A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 258
- Locations
- 2
- Primary Endpoint
- Medication Adherence
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Medication Adherence
Time Frame: 12 months
Percentage of days covered (PDC) by prescribed medication and according to claims data
Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause
Time Frame: 12 months
Days lost due to unplanned cardiovascular hospitalizations or death of any cause
Secondary Outcomes
No secondary outcomes reported