Values-Affirmation + Education Intervention Targeting Medication Adherence in Older Adults With Heart Failure
- Conditions
- Heart Failure
- Interventions
- Other: Usual CareBehavioral: Values Affirmation + Usual Care
- Registration Number
- NCT05575375
- Lead Sponsor
- The Miriam Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- Heart failure
- Enrolled in cardiac rehabilitation
- Read and understand English
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Usual Care - Values Affirmation + Usual Care Values Affirmation + Usual Care -
- Primary Outcome Measures
Name Time Method Feasibility of recruitment and retention Post-test (2-months) Proportion of eligible participants who enroll in the study, Proportion of enrolled participants who complete the study.
Acceptability of intervention and study procedures Post-test (2-months) Participant self-reported satisfaction with intervention content and delivery \[intervention group only\] and study procedures
- Secondary Outcome Measures
Name Time Method Change in Medication Adherence (electronically monitored) Baseline (30 days of monitoring), post-test (30 days of monitoring) 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)
Change in Medication Adherence (self-report) Baseline, post-test (2-months) Self-reported medication adherence will be assessed using a 7-day timeline follow-back procedure.
Change in Medication Adherence (Pill count) Baseline, post-test (2-months) Pill counts will be conducted on one medication
Trial Locations
- Locations (1)
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States