Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure

Chronic Heart Failure Clinical Trial

— PHARM-CHF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692119
• Other study ID #: PHARM-CHF
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: March 2019

Study information

• Verified date: March 2021
• Source: Federal Union of German Associations of Pharmacists
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: March 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Germany	Saarland University	Homburg/Saar

Sponsors (2)

Lead Sponsor	Collaborator
Federal Union of German Associations of Pharmacists	Universität des Saarlandes

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence	Percentage of days covered (PDC) by prescribed medication and according to claims data	12 months
Primary	Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause	Days lost due to unplanned cardiovascular hospitalizations or death of any cause	12 months

External Links

•   PHARM-CHF study home page