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

• Sponsor: Federal Union of German Associations of Pharmacists (Other)
• Overall Status: Completed
• CT.gov ID: NCT01692119
• Collaborator: Universität des Saarlandes (Other)
• Enrollment: 258
• Location: 1
• Arms: 2
• Actual Duration (Months): 76.9
• Patients Per Site Per Month: 3.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure	Behavioral: Regular, pharmacy based intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 258 participants
• 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
• Actual Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Medication Adherence [12 months]

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

2. Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saarland University	Homburg/Saar		Germany	66421

Sponsors and Collaborators

• Federal Union of German Associations of Pharmacists
• Universität des Saarlandes

Investigators

• Study Chair: Martin Schulz, Prof. PhD, Federal Union of German Associations of Pharmacists
• Study Chair: Ulrich Laufs, Prof. MD, Universitätsklinikum Leipzig

Study Documents (Full-Text)

• Statistical Analysis Plan - Feb 10, 2019
• Study Protocol - Jul 17, 2018

More Information

Additional Information:

• PHARM-CHF study home page

Publications

None provided.

• Responsible Party: Federal Union of German Associations of Pharmacists
• ClinicalTrials.gov Identifier: NCT01692119
• Other Study ID Numbers: PHARM-CHF
• First Posted: Sep 25, 2012
• Last Update Posted: Apr 22, 2021
• Last Verified: Mar 1, 2021

• 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

Study Results

Participant Flow

Arm/Group Title	Regular, Pharmacy-based Intervention	Usual Care
Arm/Group Description	providing medication in weekly dosing aids and regular contacts with the local pharmacy 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.	usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.
Period Title: Overall Study
STARTED	130	128
COMPLETED	110	127
NOT COMPLETED	20	1

Baseline Characteristics

Arm/Group Title	Regular, Pharmacy-based Intervention	Usual Care	Total
Arm/Group Description	providing medication in weekly dosing aids and regular contacts with the local pharmacy 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.	usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.	Total of all reporting groups
Overall Participants	110	127	237
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.1 (6.8)	74.1 (7.2)	74.1 (7.0)
Sex: Female, Male (Count of Participants)
Female	42 38.2%	49 38.6%	91 38.4%
Male	68 61.8%	78 61.4%	146 61.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Medication Adherence
Description	Percentage of days covered (PDC) by prescribed medication and according to claims data
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Patients for whom we were able to calculate a PDC.

Arm/Group Title	Regular, Pharmacy-based Intervention	Usual Care
Arm/Group Description	providing medication in weekly dosing aids and regular contacts with the local pharmacy 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.	usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.
Measure Participants	90	112
Mean (Standard Deviation) [percentage of days covered]	91.2 (11.9)	85.5 (16.6)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Regular, Pharmacy-based Intervention	Usual Care
Arm/Group Description	providing medication in weekly dosing aids and regular contacts with the local pharmacy 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.	usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.
Measure Participants	110	127
Mean (95% Confidence Interval) [days lost]	24.8	16.5

Adverse Events

Time Frame	365 days and until end of the study
Arm/Group Title	Regular, Pharmacy-based Intervention		Usual Care
Arm/Group Description	providing medication in weekly dosing aids and regular contacts with the local pharmacy 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.		usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.
All Cause Mortality
	Regular, Pharmacy-based Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/110 (7.3%)		8/127 (6.3%)
Serious Adverse Events
	Regular, Pharmacy-based Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/110 (0%)		0/127 (0%)
Other (Not Including Serious) Adverse Events
	Regular, Pharmacy-based Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/110 (0%)		0/127 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.