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

NCT ID: NCT05310877

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2022-08-11

Brief 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.

Detailed 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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Values-affirmation

Group Type: EXPERIMENTAL

Values-Affirmation

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. Following the intervention session, participants will receive electronic pill box(es) that are labeled with the participants' most important core value(s) and will be asked to use these pill box(es) to take their HF medications for 4 weeks.

Interventions

Values-Affirmation

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. Following the intervention session, participants will receive electronic pill box(es) that are labeled with the participants' most important core value(s) and will be asked to use these pill box(es) to take their HF medications for 4 weeks.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 55 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

5K23AG061214

Identifier Type: NIH

Identifier Source: secondary_id

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5K23AG061214

Identifier Type: NIH

Identifier Source: org_study_id

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