Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure (PHARM-CHF)

March 25, 2021 updated by: Federal Union of German Associations of Pharmacists

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Homburg/Saar, Germany, 66421
        • Saarland University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: usual care
EXPERIMENTAL: regular, pharmacy-based intervention
providing medication in weekly dosing aids and regular contacts with the local pharmacy
Behavioral: Regular, pharmacy based intervention

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Adherence
Time Frame: 12 months
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
Time Frame: 12 months
Days lost due to unplanned cardiovascular hospitalizations or death of any cause
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal Union of German Associations of Pharmacists

Collaborators

Universität des Saarlandes

Investigators

  • Study Chair: Martin Schulz, Prof. PhD, Federal Union of German Associations of Pharmacists
  • Study Chair: Ulrich Laufs, Prof. MD, Universitatsklinikum Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2012

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (ESTIMATE)

September 25, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2021

Last Update Submitted That Met QC Criteria

March 25, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHARM-CHF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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