Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure
This trial is active, not recruiting.
|Condition||chronic heart failure|
|Treatment||regular, pharmacy based intervention|
|Sponsor||Federal Union of German Associations of Pharmacists|
|Start date||October 2012|
|End date||December 2016|
|Trial size||254 participants|
|Trial identifier||NCT01692119, PHARM-CHF|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
|Primary purpose||supportive care|
time frame: 12 months
All-cause mortality or unplanned cardiovascular hospitalizations
time frame: Participants will be followed for an expected average of 21 months
Male or female participants at least 60 years old.
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)
|Official title||Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure (PHARM-CHF): A Randomized Controlled Trial|
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