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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Values Affirmation + Usual Care
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Values Affirmation + Usual Care<br> | Behavioral: Values Affirmation + Usual Care<br>* 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.<br>|
| Other: Usual Care<br> | Other: Usual Care<br>* Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment and retention | Proportion of eligible participants who enroll in the study, Proportion of enrolled participants who complete the study. | Post-test (2-months) | 
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Medication Adherence (electronically monitored) | Medication adherence will be electronically monitored. Adherence will be calculated as the overall percentage of prescribed doses taken during the monitoring period (30 days for baseline, 30 days once the intervention is initiated) | Baseline (30 days of monitoring), post-test (30 days of monitoring) | 
| Change in Medication Adherence (self-report) | Self-reported medication adherence will be assessed using a 7-day timeline follow-back procedure. | Baseline, post-test (2-months) | 
| Change in Medication Adherence (Pill count) | Pill counts will be conducted on one medication | Baseline, post-test (2-months) |