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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575375
• Other study ID #: K23AG061214
• Secondary ID: K23AG061214
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Values Affirmation + Usual Care
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.

Other:
• Usual Care
Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Information, Motivation, and -Behavioral Skills related to HF medication management	A self-report questionnaire adapted for use in HF to assess HF medication knowledge, related motivation, and behavioral skills	Baseline, post-test (2-months)
Other	Change in Positive and Negative Affect	Positive and Negative Affect Scale-Short Form	Baseline, post-test (2-months)
Other	Change in Depressive symptoms	Patient Health Questionnaire--9	Baseline, post-test (2-months)
Other	Change in Perceived Stress	Perceived Stress Scale- Short Form	Baseline, post-test (2-months)
Other	Change in Medication Self-Efficacy	Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions- Managing Medications and Treatment-Short Form 4a	Baseline, post-test (2-months)
Other	Change in Disease-related Quality of Life	Minnesota Living with Heart Failure Questionnaire	Baseline, post-test (2-months)
Other	Change in General Quality of Life	EuroQual-5 Dimension (EQ-5D)	Baseline, post-test (2-months)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	Change in Medication Adherence (Pill count)	Pill counts will be conducted on one medication	Baseline, post-test (2-months)