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

NCT05575375 | Completed Results

• 1 other identifier: K23AG061214
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Acceptability of Intervention and Study Procedures

  Participant self-reported satisfaction with intervention content and delivery \[intervention group only\] and study procedures

  Post-test (2-months)

• Retention

  Proportion of enrolled participants who completed the final assessment

  2 months

Secondary Outcomes (3)

• Medication Adherence (Electronically Monitored)

  1 month; calculated as the difference between Baseline and post-test

• Change in Medication Adherence (Self-report)

  Baseline, post-test (2-months)

• Medication Adherence (Pill Count)

  Baseline, post-test (2-months)

Other Outcomes (5)

• Positive and Negative Affect

  Baseline, post-test (2-months)

• Perceived Stress-4

  Baseline, post-test (2-months)

• Medication Self-Efficacy

  Baseline, post-test (2-months)

Study Arms (2)

Values Affirmation + Usual Care

EXPERIMENTAL

Behavioral: Values Affirmation + Usual Care

Usual Care

OTHER

Other: Usual Care

Interventions

Values Affirmation + Usual Care 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.

Values Affirmation + Usual Care

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart failure
• Enrolled in cardiac rehabilitation
• Read and understand English

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Emily Gathright
• Organization: The Miriam Hospital

emily.gathright@brownhealth.org

4017938271

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 12, 2022
• Study Start: September 15, 2022
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: November 24, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-01

Locations

US (1)