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

Not Applicable
Completed
Conditions
Heart Failure
Interventions
Behavioral: Values-Affirmation
Registration Number
NCT05310877
Lead Sponsor
The Miriam Hospital
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
7
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Values-affirmationValues-Affirmation-
Primary Outcome Measures
NameTimeMethod
Feasibility of Intervention ProceduresWeek 4

Proportion of enrolled participants who complete the study

Feasibility of Recruitment ProceduresBaseline

Proportion of eligible participants who enroll in the study

Acceptability Assessed Via Qualitative Exit Interview- Number of Participants Who Completed InterviewWeek 4

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

Secondary Outcome Measures
NameTimeMethod
Self-reported Medication AdherenceBaseline, 4 weeks

Timeline follow-back interview

Trial Locations

Locations (1)

The Miriam Hospital

🇺🇸

Providence, Rhode Island, United States

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