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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Values Affirmation + Usual Care; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Retention	Proportion of enrolled participants who completed the final assessment	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence (Electronically Monitored)	Medication adherence will be electronically monitored. Adherence will be calculated as the overall percentage of days in which participants took their medications as prescribed during the monitoring period (30 days for baseline, 30 days post-intervention initiation)	1 month; calculated as the difference between Baseline and post-test
Change in Medication Adherence (Self-report)	Self-reported medication adherence assessed with the Medication Adherence Scale (MAS; Wu et al., 2008). The MAS is a 32-item scale with three subscales - knowledge, attitudes, and barriers-- in addition to items assessing medication-taking behaviors. The 3 subscales are scored by summing items relevant to each subscale. Knowledge subscale scores range from 0 to 30; higher scores indicate greater medication knowledge. Attitudes subscale scores range from 0 to 40, with higher scores indicated report of a more positive attitude towards medication taking. The Barriers subscale scores range from 0 to 110, with higher scores indicated report of more barriers to taking medications as prescribed.	Baseline, post-test (2-months)
Medication Adherence (Pill Count)	Pill counts will be conducted on one medication	Baseline, post-test (2-months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in General Quality of Life	EuroQual-5 Dimension (EQ-5D)	Baseline, post-test (2-months)
Positive and Negative Affect	Positive and Negative Affect Scale-Short Form (I-PANAS-SF). Two subscales are computed-- the positive affect score and the negative affect score. On both subscales, scores can range from 5 - 25 with higher scores indicating higher positive or negative affect, respectively.	Baseline, post-test (2-months)
Perceived Stress-4	Perceived Stress Scale- 4; total scores range from 0 to 16 with higher scores indicating greater perceived stress over the past month.	Baseline, post-test (2-months)
Medication Self-Efficacy	Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions- Managing Medications and Treatment-Short Form 4a Raw scores range from 4 to 20; raw scores were transformed to T-scores with a mean of 50 and a standard deviation of 10. Higher scores reflect higher self-efficacy.	Baseline, post-test (2-months)
Disease-related Quality of Life	Minnesota Living with Heart Failure Questionnaire; Total scores range from 0 to 105. Higher scores indicate worse health status.	Baseline, post-test (2-months)

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: K23AG061214 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No