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Clinical Trials/NCT01692119
NCT01692119
Completed
Not Applicable

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

Federal Union of German Associations of Pharmacists1 site in 1 country258 target enrollmentOctober 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Heart Failure
Sponsor
Federal Union of German Associations of Pharmacists
Enrollment
258
Locations
1
Primary Endpoint
Medication Adherence
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
March 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal Union of German Associations of Pharmacists
Responsible Party
Sponsor

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)

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

Study Sites (1)

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