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Completed

NCT Number: NCT01692119

Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure

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.

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Key information

Conditions

Chronic Heart Failure Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saarland University

Homburg/Saar, 66421, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Regular, pharmacy based intervention

Behavioral

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.

Primary outcomes

  1. Medication Adherence

    Time frame: 12 months

    Percentage of days covered (PDC) by prescribed medication and according to claims data

  2. 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

Sponsors and collaborators

Lead sponsor

Federal Union of German Associations of Pharmacists

Other

Collaborators

  • Universität des Saarlandes

Registry information

Official study title

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

Acronym: PHARM-CHF

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Sep 25, 2012
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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