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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
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
March 22, 2022
Last Updated
May 30, 2023
Sponsor
The Miriam Hospital
Collaborators
National Institute on Aging (NIA)
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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

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

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