Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure

Not Applicable

Completed

• Conditions: Chronic Heart Failure
• Interventions: Behavioral: Regular, pharmacy based intervention

• Registration Number: NCT01692119
• Lead Sponsor: Federal Union of German Associations of Pharmacists

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-25
• Study Start: 2012-10
• Primary Completion: 2018-06
• Study Completion: 2019-03
• Status Verified: 2021-03
• Results First Submitted: 2021-03-02
• Results First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-25
• Results First Posted: 2021-03-26
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
regular, pharmacy-based intervention	Regular, pharmacy based intervention	providing medication in weekly dosing aids and regular contacts with the local pharmacy

Primary Outcome Measures

Name	Time	Method
Medication Adherence	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	12 months	Days lost due to unplanned cardiovascular hospitalizations or death of any cause

Trial Locations

Locations (1)

Saarland University; 🇩🇪 Homburg/Saar, Germany