NCT01692119

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

March 26, 2021

Completed
Last Updated

April 22, 2021

Status Verified

March 1, 2021

Enrollment Period

5.7 years

First QC Date

September 17, 2012

Results QC Date

March 2, 2021

Last Update Submit

March 25, 2021

Conditions

Chronic Heart Failure

Keywords

chronic heart failuremedication adherencepharmacyinterdisciplinary carerandomized controlled trialmortalityhospitalization

Outcome Measures

Primary Outcomes (2)

  • Medication Adherence

    Percentage of days covered (PDC) by prescribed medication and according to claims data

    12 months

  • 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

Study Arms (2)

regular, pharmacy-based intervention

EXPERIMENTAL

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

Behavioral: Regular, pharmacy based intervention

usual care

NO INTERVENTION

usual care

Interventions

Regular, pharmacy based interventionBEHAVIORAL

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.

regular, pharmacy-based intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saarland University

Homburg/Saar, 66421, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29846031DERIVED

Related Links

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dr. Martin Schulz
Organization
ABDA, Department of Medicine
arzneimittel@abda.de
+49 30 40004-514

Study Officials

  • Martin Schulz, Prof. PhD

    Federal Union of German Associations of Pharmacists

    STUDY CHAIR

  • Ulrich Laufs, Prof. MD

    Universitätsklinikum Leipzig

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 25, 2012

Study Start

October 1, 2012

Primary Completion

June 1, 2018

Study Completion

March 1, 2019

Last Updated

April 22, 2021

Results First Posted

March 26, 2021

Record last verified: 2021-03

Locations

DE(1)