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

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Regular, pharmacy based intervention
Sponsored by
Federal Union of German Associations of Pharmacists
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Heart Failure focused on measuring chronic heart failure, medication adherence, pharmacy, interdisciplinary care, randomized controlled trial, mortality, hospitalization

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Saarland University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

regular, pharmacy-based intervention

usual care

Arm Description

providing medication in weekly dosing aids and regular contacts with the local pharmacy

usual care

Outcomes

Primary Outcome Measures

Medication Adherence
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
Days lost due to unplanned cardiovascular hospitalizations or death of any cause

Secondary Outcome Measures

Full Information

First Posted
September 17, 2012
Last Updated
March 25, 2021
Sponsor
Federal Union of German Associations of Pharmacists
Collaborators
Universität des Saarlandes
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1. Study Identification

Unique Protocol Identification Number
NCT01692119
Brief Title
Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure
Acronym
PHARM-CHF
Official Title
Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure (PHARM-CHF): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Union of German Associations of Pharmacists
Collaborators
Universität des Saarlandes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
chronic heart failure, medication adherence, pharmacy, interdisciplinary care, randomized controlled trial, mortality, hospitalization

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
regular, pharmacy-based intervention
Arm Type
Experimental
Arm Description
providing medication in weekly dosing aids and regular contacts with the local pharmacy
Arm Title
usual care
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
Regular, pharmacy based intervention
Intervention Description
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 Outcome Measure Information:
Title
Medication Adherence
Description
Percentage of days covered (PDC) by prescribed medication and according to claims data
Time Frame
12 months
Title
Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause
Description
Days lost due to unplanned cardiovascular hospitalizations or death of any cause
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Schulz, Prof. PhD
Organizational Affiliation
Federal Union of German Associations of Pharmacists
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ulrich Laufs, Prof. MD
Organizational Affiliation
Universitätsklinikum Leipzig
Official's Role
Study Chair
Facility Information:
Facility Name
Saarland University
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
29846031
Citation
Laufs U, Griese-Mammen N, Krueger K, Wachter A, Anker SD, Koehler F, Rettig-Ewen V, Botermann L, Strauch D, Trenk D, Bohm M, Schulz M. PHARMacy-based interdisciplinary program for patients with Chronic Heart Failure (PHARM-CHF): rationale and design of a randomized controlled trial, and results of the pilot study. Eur J Heart Fail. 2018 Sep;20(9):1350-1359. doi: 10.1002/ejhf.1213. Epub 2018 May 30.
Results Reference
derived
Links:
URL
http://www.pharm-chf.de
Description
PHARM-CHF study home page

Learn more about this trial

Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure

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