Pilot Randomized Controlled Trial of a Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- The Miriam Hospital
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Acceptability of Intervention and Study Procedures
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Acceptability of Intervention and Study Procedures
Time Frame: Post-test (2-months)
Participant self-reported satisfaction with intervention content and delivery \[intervention group only\] and study procedures
Retention
Time Frame: 2 months
Proportion of enrolled participants who completed the final assessment
Secondary Outcomes
- 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))