This trial is active, not recruiting.

Condition chronic heart failure
Treatment regular, pharmacy based intervention
Sponsor Federal Union of German Associations of Pharmacists
Collaborator Saarland University
Start date October 2012
End date December 2016
Trial size 254 participants
Trial identifier NCT01692119, PHARM-CHF


The aim of the study is to investigate whether a continuous interdisciplinary intervention improves medication adherence and leads to a reduction of hospitalizations and mortality 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
providing medication in weekly dosing aids and regular contacts with the local pharmacy
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.
(No Intervention)
usual care

Primary Outcomes

Medication adherence
time frame: 12 months
All-cause mortality or unplanned cardiovascular hospitalizations
time frame: Participants will be followed for an expected average of 21 months

Eligibility Criteria

Male or female participants at least 60 years old.

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 3 months)

Additional Information

Official title Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure (PHARM-CHF): A Randomized Controlled Trial
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Federal Union of German Associations of Pharmacists.