Values-Affirmation + Education Intervention Targeting Medication Adherence in Older Adults With Heart Failure
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Values Affirmation + Usual Care
Usual Care
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
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
Sites / Locations
- The Miriam HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Values Affirmation + Usual Care
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of recruitment and retention
Proportion of eligible participants who enroll in the study, Proportion of enrolled participants who complete the study.
Acceptability of intervention and study procedures
Participant self-reported satisfaction with intervention content and delivery [intervention group only] and study procedures
Secondary Outcome Measures
Change in Medication Adherence (electronically monitored)
Medication adherence will be electronically monitored. Adherence will be calculated as the overall percentage of prescribed doses taken during the monitoring period (30 days for baseline, 30 days once the intervention is initiated)
Change in Medication Adherence (self-report)
Self-reported medication adherence will be assessed using a 7-day timeline follow-back procedure.
Change in Medication Adherence (Pill count)
Pill counts will be conducted on one medication
Full Information
NCT ID
NCT05575375
First Posted
October 3, 2022
Last Updated
October 10, 2022
Sponsor
The Miriam Hospital
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05575375
Brief Title
Values-Affirmation + Education Intervention Targeting Medication Adherence in Older Adults With Heart Failure
Official Title
Pilot Randomized Controlled Trial 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
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)
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
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.
Detailed 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.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Values Affirmation + Usual Care
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Values Affirmation + Usual Care
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. The participant's study medication monitoring devices will be labeled with the participants' most important core value(s). Participants will also continue with their usual care.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)
Primary Outcome Measure Information:
Title
Feasibility of recruitment and retention
Description
Proportion of eligible participants who enroll in the study, Proportion of enrolled participants who complete the study.
Time Frame
Post-test (2-months)
Title
Acceptability of intervention and study procedures
Description
Participant self-reported satisfaction with intervention content and delivery [intervention group only] and study procedures
Time Frame
Post-test (2-months)
Secondary Outcome Measure Information:
Title
Change in Medication Adherence (electronically monitored)
Description
Medication adherence will be electronically monitored. Adherence will be calculated as the overall percentage of prescribed doses taken during the monitoring period (30 days for baseline, 30 days once the intervention is initiated)
Time Frame
Baseline (30 days of monitoring), post-test (30 days of monitoring)
Title
Change in Medication Adherence (self-report)
Description
Self-reported medication adherence will be assessed using a 7-day timeline follow-back procedure.
Time Frame
Baseline, post-test (2-months)
Title
Change in Medication Adherence (Pill count)
Description
Pill counts will be conducted on one medication
Time Frame
Baseline, post-test (2-months)
Other Pre-specified Outcome Measures:
Title
Change in Information, Motivation, and -Behavioral Skills related to HF medication management
Description
A self-report questionnaire adapted for use in HF to assess HF medication knowledge, related motivation, and behavioral skills
Time Frame
Baseline, post-test (2-months)
Title
Change in Positive and Negative Affect
Description
Positive and Negative Affect Scale-Short Form
Time Frame
Baseline, post-test (2-months)
Title
Change in Depressive symptoms
Description
Patient Health Questionnaire--9
Time Frame
Baseline, post-test (2-months)
Title
Change in Perceived Stress
Description
Perceived Stress Scale- Short Form
Time Frame
Baseline, post-test (2-months)
Title
Change in Medication Self-Efficacy
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions- Managing Medications and Treatment-Short Form 4a
Time Frame
Baseline, post-test (2-months)
Title
Change in Disease-related Quality of Life
Description
Minnesota Living with Heart Failure Questionnaire
Time Frame
Baseline, post-test (2-months)
Title
Change in General Quality of Life
Description
EuroQual-5 Dimension (EQ-5D)
Time Frame
Baseline, post-test (2-months)
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
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
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily C Gathright, PhD
Phone
401-793-8271
Email
Emily.Gathright@Lifespan.org
12. IPD Sharing Statement
Learn more about this trial
Values-Affirmation + Education Intervention Targeting Medication Adherence in Older Adults With Heart Failure
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