Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Values-Affirmation
Sponsored by

About this trial
This is an interventional other trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- The Miriam Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Values-affirmation
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of Recruitment Procedures
Proportion of eligible participants who enroll in the study
Feasibility of Intervention Procedures
Proportion of enrolled participants who complete the study
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
Secondary Outcome Measures
Self-reported Medication Adherence
Timeline follow-back interview
Full Information
NCT ID
NCT05310877
First Posted
March 22, 2022
Last Updated
May 30, 2023
Sponsor
The Miriam Hospital
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05310877
Brief Title
Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure
Official Title
Feasibility and Acceptability of a Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
August 11, 2022 (Actual)
Study Completion Date
August 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Values-affirmation
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Values-Affirmation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of Recruitment Procedures
Description
Proportion of eligible participants who enroll in the study
Time Frame
Baseline
Title
Feasibility of Intervention Procedures
Description
Proportion of enrolled participants who complete the study
Time Frame
Week 4
Title
Acceptability Assessed Via Qualitative Exit Interview- Number of Participants Who Completed Interview
Description
Qualitative exit interview to assess patient reported satisfaction with intervention content, intervention delivery, and study procedures
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Self-reported Medication Adherence
Description
Timeline follow-back interview
Time Frame
Baseline, 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure
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