Skip to main content
OpenTrials
Completed

NCT Number: NCT05310877

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

Heart failure (HF) represents a significant public health concern. Medication non-adherence represents 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. Similar interventions have promoted weight loss, increased adherence and physical activity, and more frequent fruit and vegetable consumption in a variety of contexts and populations. This study seeks to test a recently developed values-affirmation intervention targeting medication adherence in older adults with HF enrolled in cardiac rehabilitation (CR). The purpose of this feasibility study is to test methodology to aid development of a subsequent randomized controlled pilot trial to examine preliminary efficacy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

55 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

The objective of this study is to examine the preliminary feasibility and acceptability of study procedures and the values-affirmation intervention in a single-arm trial. Participants will be asked to complete a brief intervention with tailored education relevant to medication information, motivation, and behavioral skills. Participants will complete a baseline assessment and a follow-up assessment at one month post-intervention. The investigators hypothesize that the developed study and intervention procedures will be feasible and acceptable to participants. The investigators will also examine changes in self-reported and electronically monitored medication adherence from the baseline assessment to follow-up.

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
  • At risk for medication non-adherence based on self-report screening or number of prescribed medications

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
  • Terminal illness with an expected lifespan of less than 6 months

Treatment and study plan

Values-Affirmation

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. Following the intervention session, participants will receive electronic pill box(es) that are labeled with the participants' most important core value(s) and will be asked to use these pill box(es) to take their HF medications for 4 weeks.

Primary outcomes

  1. Feasibility of Recruitment Procedures

    Time frame: Baseline

    Proportion of eligible participants who enroll in the study

  2. Feasibility of Intervention Procedures

    Time frame: Week 4

    Proportion of enrolled participants who complete the study

  3. Acceptability Assessed Via Qualitative Exit Interview- Number of Participants Who Completed Interview

    Time frame: Week 4

    Qualitative exit interview to assess patient reported satisfaction with intervention content, intervention delivery, and study procedures

Secondary outcomes

  1. Self-reported Medication Adherence

    Time frame: Baseline, 4 weeks

    Timeline follow-back interview

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Feasibility and Acceptability of a Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
Jun 22, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.