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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01692119
First Posted: September 25, 2012
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Saarland University
Information provided by (Responsible Party):
Federal Union of German Associations of Pharmacists
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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:
  • 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 ]
    composite, recurrent event, number


Enrollment: 258
Actual Study Start Date: October 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: February 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692119


Locations
Germany
Saarland University
Homburg/Saar, Germany, 66421
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:
Responsible Party: Federal Union of German Associations of Pharmacists
ClinicalTrials.gov Identifier: NCT01692119     History of Changes
Other Study ID Numbers: PHARM-CHF
First Submitted: September 17, 2012
First Posted: September 25, 2012
Last Update Posted: January 30, 2017
Last Verified: January 2017

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
Heart Diseases
Cardiovascular Diseases