Clinical trial NCT05575375: Values-Affirmation + Education Intervention Targeting Medication Adherence in Older Adults With Heart Failure
Official title: Pilot Randomized Controlled Trial of a Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-10-12
Enrollment: 43
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Feasibility of recruitment and retention
timeFrame: Post-test (2-months)
measure: Acceptability of intervention and study procedures
timeFrame: Post-test (2-months)
Secondary outcomes:
measure: Change in Medication Adherence (electronically monitored)
timeFrame: Baseline (30 days of monitoring), post-test (30 days of monitoring)
measure: Change in Medication Adherence (self-report)
timeFrame: Baseline, post-test (2-months)
measure: Change in Medication Adherence (Pill count)
timeFrame: Baseline, post-test (2-months)
Other outcomes:
measure: Change in Information, Motivation, and -Behavioral Skills related to HF medication management
timeFrame: Baseline, post-test (2-months)
measure: Change in Positive and Negative Affect
timeFrame: Baseline, post-test (2-months)
measure: Change in Depressive symptoms
timeFrame: Baseline, post-test (2-months)
measure: Change in Perceived Stress
timeFrame: Baseline, post-test (2-months)
measure: Change in Medication Self-Efficacy
timeFrame: Baseline, post-test (2-months)
measure: Change in Disease-related Quality of Life
timeFrame: Baseline, post-test (2-months)
measure: Change in General Quality of Life
timeFrame: Baseline, post-test (2-months)
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
References: