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

NCT05310877 | Completed Results

• 1 other identifier: 5K23AG061214
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• Feasibility of Recruitment Procedures

  Proportion of eligible participants who enroll in the study

  Baseline

• Feasibility of Intervention Procedures

  Proportion of enrolled participants who complete the study

  Week 4

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

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

  Week 4

Secondary Outcomes (1)

• Self-reported Medication Adherence

  Baseline, 4 weeks

Study Arms (1)

Values-affirmation

EXPERIMENTAL

Behavioral: Values-Affirmation

Interventions

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.

Values-affirmation

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Emily Gathright, PhD
• Organization: The Miriam Hospital

Emily.Gathright@lifespan.org

401-793-8271

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 5, 2022
• Study Start: February 23, 2022
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2022-09

Locations

US (1)