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

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Lifespan

Status

Completed

Conditions

Heart Failure

Treatments

Behavioral: Values Affirmation + Usual Care
Other: Usual Care

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05575375
K23AG061214 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

43 participants in 2 patient groups

Values Affirmation + Usual Care
Experimental group
Treatment:
Behavioral: Values Affirmation + Usual Care
Usual Care
Other group
Treatment:
Other: Usual Care

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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