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

Sponsor

The Miriam Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05310877

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arm

4.2

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Behavioral: Values-Affirmation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 23, 2022

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Values-affirmation	Behavioral: Values-Affirmation 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.

Arm

Intervention/Treatment

Experimental: Values-affirmation

Behavioral: Values-Affirmation

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.

Outcome Measures

Primary Outcome Measures

Feasibility of recruitment procedures [Baseline]
Proportion of eligible participants who enroll in the study
Feasibility of intervention procedures [Week 4]
Proportion of enrolled participants who complete the study
Acceptability assessed via qualitative exit interview [Week 4]
Qualitative exit interview to assess patient reported satisfaction with intervention content, intervention delivery, and study procedures

Secondary Outcome Measures

Self-reported medication adherence [Baseline, Week 4]
Timeline follow-back interview

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Miriam Hospital	Providence	Rhode Island	United States	02906

Sponsors and Collaborators

The Miriam Hospital
National Institute on Aging (NIA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Miriam Hospital

ClinicalTrials.gov Identifier:

NCT05310877

Other Study ID Numbers:

5K23AG061214
5K23AG061214

First Posted:

Apr 5, 2022

Last Update Posted:

Apr 5, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Apr 5, 2022