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

NCT ID: NCT05575375

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2025-01-15

Brief 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.

Detailed 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Values Affirmation + Usual Care

Group Type: EXPERIMENTAL

Values Affirmation + Usual Care

Intervention Type: BEHAVIORAL

Participants will engage in a brief values-affirmation exercise to target personal motivation and openness to medication adherence. The interventionist will then review tailored medication education and individual skills training recommendations. The participant's study medication monitoring devices will be labeled with the participants' most important core value(s). Participants will also continue with their usual care.

Usual Care

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)

Interventions

Values Affirmation + Usual Care

Participants will engage in a brief values-affirmation exercise to target personal motivation and openness to medication adherence. The interventionist will then review tailored medication education and individual skills training recommendations. The participant's study medication monitoring devices will be labeled with the participants' most important core value(s). Participants will also continue with their usual care.

Intervention Type: BEHAVIORAL

Usual Care

Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

K23AG061214

Identifier Type: NIH

Identifier Source: secondary_id

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K23AG061214

Identifier Type: NIH

Identifier Source: org_study_id

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