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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05310877
• Other study ID #: 5K23AG061214
• Secondary ID: 5K23AG061214
• Status: Completed
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: August 11, 2022

Study information

• Verified date: September 2022
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 11, 2022
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Recruitment Procedures	Proportion of eligible participants who enroll in the study	Baseline
Primary	Feasibility of Intervention Procedures	Proportion of enrolled participants who complete the study	Week 4
Primary	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	Self-reported Medication Adherence	Timeline follow-back interview	Baseline, 4 weeks