Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure (PHARM-CHF): A Randomized Controlled Trial

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Behavioral: Regular, pharmacy based intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: regular, pharmacy-based intervention<br>providing medication in weekly dosing aids and regular contacts with the local pharmacy | Behavioral: Regular, pharmacy based intervention<br>* Regular, pharmacy-based intervention conducted in cooperation with the treating physician: Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan. Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician.<br>|
| No Intervention: usual care<br>usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence | Percentage of days covered (PDC) by prescribed medication and according to claims data | 12 months | 
| Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause | Days lost due to unplanned cardiovascular hospitalizations or death of any cause | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic heart failure, medication adherence, pharmacy, interdisciplinary care, randomized controlled trial, mortality, hospitalization