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

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Lifespan

Status

Completed

Conditions

Heart Failure

Treatments

Behavioral: Values-Affirmation

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05310877
5K23AG061214 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

Values-affirmation
Experimental group
Treatment:
Behavioral: Values-Affirmation

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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