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

Study Overview
=================
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.

Official Title
-----------------
Feasibility and Acceptability of a Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Behavioral: Values-Affirmation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Values-affirmation<br> | Behavioral: Values-Affirmation<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. 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Recruitment Procedures | Proportion of eligible participants who enroll in the study | Baseline | 
| Feasibility of Intervention Procedures | Proportion of enrolled participants who complete the study | Week 4 | 
| Acceptability Assessed Via Qualitative Exit Interview- Number of Participants Who Completed Interview | Qualitative exit interview to assess patient reported satisfaction with intervention content, intervention delivery, and study procedures | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Medication Adherence | Timeline follow-back interview | Baseline, 4 weeks |