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Completed

NCT Number: NCT05575375

Values-Affirmation + Education 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Values Affirmation + Usual Care

Behavioral

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.

Usual Care

Other

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

Primary outcomes

  1. Acceptability of Intervention and Study Procedures

    Time frame: Post-test (2-months)

    Participant self-reported satisfaction with intervention content and delivery [intervention group only] and study procedures

  2. Retention

    Time frame: 2 months

    Proportion of enrolled participants who completed the final assessment

Secondary outcomes

  1. Medication Adherence (Electronically Monitored)

    Time frame: 1 month; calculated as the difference between Baseline and post-test

    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)

  2. Change in Medication Adherence (Self-report)

    Time frame: Baseline, post-test (2-months)

    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.

  3. Medication Adherence (Pill Count)

    Time frame: Baseline, post-test (2-months)

    Pill counts will be conducted on one medication

Other outcomes

  1. Positive and Negative Affect

    Time frame: Baseline, post-test (2-months)

    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.

  2. Perceived Stress-4

    Time frame: Baseline, post-test (2-months)

    Perceived Stress Scale- 4; total scores range from 0 to 16 with higher scores indicating greater perceived stress over the past month.

  3. Medication Self-Efficacy

    Time frame: Baseline, post-test (2-months)

    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.

  4. Disease-related Quality of Life

    Time frame: Baseline, post-test (2-months)

    Minnesota Living with Heart Failure Questionnaire; Total scores range from 0 to 105. Higher scores indicate worse health status.

  5. Change in General Quality of Life

    Time frame: Baseline, post-test (2-months)

    EuroQual-5 Dimension (EQ-5D)

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 12, 2022
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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