Heart Failure Clinical Trial

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

Summary

Heart failure (HF) represents a significant public health concern. Medication non-adherence represents 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. Similar interventions have promoted weight loss, increased adherence and physical activity, and more frequent fruit and vegetable consumption in a variety of contexts and populations. This study seeks to test a recently developed values-affirmation intervention targeting medication adherence in older adults with HF enrolled in cardiac rehabilitation (CR). The purpose of this feasibility study is to test methodology to aid development of a subsequent randomized controlled pilot trial to examine preliminary efficacy.

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Full Description

The objective of this study is to examine the preliminary feasibility and acceptability of study procedures and the values-affirmation intervention in a single-arm trial. Participants will be asked to complete a brief intervention with tailored education relevant to medication information, motivation, and behavioral skills. Participants will complete a baseline assessment and a follow-up assessment at one month post-intervention. The investigators hypothesize that the developed study and intervention procedures will be feasible and acceptable to participants. The investigators will also examine changes in self-reported and electronically monitored medication adherence from the baseline assessment to follow-up.

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Eligibility Criteria

Inclusion Criteria:

Heart failure
Enrolled in cardiac rehabilitation
Read and understand English
At risk for medication non-adherence based on self-report screening or number of prescribed medications

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
Terminal illness with an expected lifespan of less than 6 months

Study is for people with:

Heart Failure

Estimated Enrollment:

7

Study ID:

NCT05310877

Recruitment Status:

Completed

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

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Study is for people with:

Heart Failure

Estimated Enrollment:

7

Study ID:

NCT05310877

Recruitment Status:

Completed

Sponsor:


The Miriam Hospital

How clear is this clinincal trial information?

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