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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Federal Union of German Associations of Pharmacists
Sponsor:
Collaborator:
Saarland University
Information provided by (Responsible Party):
Federal Union of German Associations of Pharmacists
ClinicalTrials.gov Identifier:
NCT01692119
First received: September 17, 2012
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

The aim of the study is to investigate, whether a continuous interdisciplinary intervention 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.


Condition Intervention
Chronic Heart Failure
Behavioral: Regular, pharmacy based intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure (PHARM-CHF): A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Federal Union of German Associations of Pharmacists:

Primary Outcome Measures:
  • All-cause mortality or unplanned cardiovascular hospitalizations [ Time Frame: Participants will be followed for an expected average of 21 months ] [ Designated as safety issue: No ]
    composite, recurrent event, number


Estimated Enrollment: 2060
Study Start Date: October 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: usual care
usual care

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 3 months)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692119

Contacts
Contact: Martin Schulz, Prof. PhD +49 (0) 30 40004 ext 511 arzneimittel@abda.aponet.de
Contact: Ulrich Laufs, Prof. MD +49 (0) 6841 162 ext 3412 pharm.chf@uks.eu

Locations
Germany
Saarland University Recruiting
Homburg/Saar, Germany, 66421
Contact: Ulrich Laufs, Prof. MD    +49 (0)6841-162 ext 3412    pharm.chf@uks.eu   
Principal Investigator: Ulrich Laufs, Prof. MD         
Sponsors and Collaborators
Federal Union of German Associations of Pharmacists
Saarland University
Investigators
Study Chair: Martin Schulz, Prof. PhD Federal Union of German Associations of Pharmacists
Study Chair: Ulrich Laufs, Prof. MD Saarland University
  More Information

Additional Information:
No publications provided

Responsible Party: Federal Union of German Associations of Pharmacists
ClinicalTrials.gov Identifier: NCT01692119     History of Changes
Other Study ID Numbers: PHARM-CHF
Study First Received: September 17, 2012
Last Updated: October 14, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Federal Union of German Associations of Pharmacists:
chronic heart failure
medication adherence
pharmacy
interdisciplinary care
randomized controlled trial
mortality
hospitalization

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 29, 2014