NCT05575375

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

Pilot Randomized Controlled Trial of a Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: The Miriam Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
OTHER	Usual Care	Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)

Timeline

• Start date: 2022-09-15
• Primary completion: 2025-01-15
• Completion: 2025-01-15
• First posted: 2022-10-12
• Last updated: 2025-11-24
• Results posted: 2025-11-24

Locations

1 site across 1 country: United States