Heart Failure Clinical Trial

Values-Affirmation + Education Intervention Targeting Medication Adherence in Older Adults With Heart Failure

Summary

The goals of this study are to determine the (1) feasibility and (2) acceptability of the study procedures through a pilot randomized controlled trial of a values affirmation intervention targeting medication adherence in adults with heart failure enrolled in cardiac rehabilitation relative to usual care.

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Full Description

Heart failure (HF) represents a significant public health concern. Medication non-adherence is a modifiable contributor to costly hospital readmissions in older adults with HF. Educational interventions improve, but do not eliminate, non-adherence. Values affirmation interventions which invite individuals to reflect on core values may encourage better engagement in health behaviors by increasing the personal relevance of targeted behaviors. This study tests a values-affirmation intervention targeting medication adherence in older adults with HF enrolled in cardiac rehabilitation.

The objective of this study is to examine the feasibility and acceptability of study procedures and the values-affirmation intervention in a pilot randomized controlled trial. Participants will complete a baseline assessment including 30 days of medication monitoring using electronic medication monitoring devices. After the baseline medication monitoring period, participants will be randomly assigned to either the intervention or control condition. Intervention participants will be asked to complete a brief intervention with tailored education relevant to medication information, motivation, and behavioral skills in additional to their usual cardiac rehabilitation care. Control participants will continue with their usual care. Participants will be asked to continue using the medication monitoring devices and to complete a final assessment 30 days later.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Heart failure
Enrolled in cardiac rehabilitation
Read and understand English

Exclusion Criteria:

Current participation in another medication-monitoring clinical or research protocol
New York Heart Association class IV heart failure
Diagnosis of Alzheimer's, dementia, or severe cognitive impairment indicated on screening
Current suicidality or psychosis

Study is for people with:

Heart Failure

Estimated Enrollment:

50

Study ID:

NCT05575375

Recruitment Status:

Recruiting

Sponsor:

The Miriam Hospital

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There is 1 Location for this study

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The Miriam Hospital
Providence Rhode Island, 02906, United States More Info
Emily C Gathright, PhD
Contact
401-793-8271
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

50

Study ID:

NCT05575375

Recruitment Status:

Recruiting

Sponsor:


The Miriam Hospital

How clear is this clinincal trial information?

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