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Heart Smart: A Virtual Self-Management Program for Homebound People With Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart Smart Virtual Self-Management Group
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, telehealth, occupational therapy, self-management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of heart failure
  • Receiving home health care from Penn Medicine at Home at time of screening.
  • Technology capabilities to participate in the program (laptop or tablet with a camera, internet access).
  • Able to read and write in English.
  • Cognitive ability to participate in the program if the participant is able to score12/15 on the Montreal Cognitive Assessment (MoCA) 5 Minute Phone Test.

Exclusion Criteria:

  • Hearing impairment that impacts communication.
  • Previous experience receiving occupational therapy services from the principal investigator.

Sites / Locations

  • Penn Medicine at Home

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heart Smart Group

Arm Description

Receives Heart Smart Intervention

Outcomes

Primary Outcome Measures

Change in Self-Efficacy Measure for Chronic Disease (SEMCD)
This self-report scale has 6 items which are each rated on a scale of 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the scores for the six items. Possible scores are 1-10 with higher scores indicating higher self-efficacy. This scale is an appropriate outcome measure for a heart failure self-management group because it was designed to measure self-efficacy in people with chronic conditions such as heart failure and has undergone psychometric evaluation. This scale is free to use without permission. Administration takes less than 10 minutes.

Secondary Outcome Measures

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
This 23-item, Likert scale, self-report heart failure specific outcome measure. The instrument measures six domains: physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. This instrument is appropriate because it is designed for use for people with heart failure, will give an indication of participant heart failure severity for demographic purposes, and has a validated self-efficacy component. This scale requires a license which has been obtained for this pilot project. Administration takes less than 10 minutes. Scores range from 0 to 100 with higher scores indicating higher cardiac health status.
Change in Atlanta Heart Failure Knowledge Test V3 (AHFKT)
This 30 item multiple choice measure of heart failure self-management knowledge yields scores 0-30 which are commonly reported as a percentage (higher scores indicate more knowledge). Content validity was established through a panel of expert heart failure nurses.

Full Information

First Posted
August 31, 2021
Last Updated
March 7, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05057364
Brief Title
Heart Smart: A Virtual Self-Management Program for Homebound People With Heart Failure
Official Title
Heart Smart: A Virtual Self-Management Program for Homebound People With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this capstone project is to pilot Heart Smart, a virtual group program to improve self-efficacy for self-management skills for homebound people with heart failure.
Detailed Description
The purpose of this capstone project is to pilot Heart Smart, a virtual group program to improve self-efficacy for self-management skills for homebound people with heart failure. Heart Smart will provide synchronous virtual group education to homebound people with heart failure receiving services from Penn Medicine at Home. The primary clinical goal is to improve self-efficacy for heart failure self-management and improve their knowledge of heart failure self-management strategies. Secondary outcomes will explore the feasibility of the program by exploring technology, adherence and satisfaction with the program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, telehealth, occupational therapy, self-management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study, single group, no control. pre-post data collection
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heart Smart Group
Arm Type
Experimental
Arm Description
Receives Heart Smart Intervention
Intervention Type
Other
Intervention Name(s)
Heart Smart Virtual Self-Management Group
Intervention Description
The Heart Smart Intervention is a 6 week virtual program consisting of one individual technology training session followed by 5 one hour group education sessions.
Primary Outcome Measure Information:
Title
Change in Self-Efficacy Measure for Chronic Disease (SEMCD)
Description
This self-report scale has 6 items which are each rated on a scale of 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the scores for the six items. Possible scores are 1-10 with higher scores indicating higher self-efficacy. This scale is an appropriate outcome measure for a heart failure self-management group because it was designed to measure self-efficacy in people with chronic conditions such as heart failure and has undergone psychometric evaluation. This scale is free to use without permission. Administration takes less than 10 minutes.
Time Frame
At first and final sessions (weeks 1 and 6)
Secondary Outcome Measure Information:
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
This 23-item, Likert scale, self-report heart failure specific outcome measure. The instrument measures six domains: physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. This instrument is appropriate because it is designed for use for people with heart failure, will give an indication of participant heart failure severity for demographic purposes, and has a validated self-efficacy component. This scale requires a license which has been obtained for this pilot project. Administration takes less than 10 minutes. Scores range from 0 to 100 with higher scores indicating higher cardiac health status.
Time Frame
At first and final sessions (weeks 1 and 6)
Title
Change in Atlanta Heart Failure Knowledge Test V3 (AHFKT)
Description
This 30 item multiple choice measure of heart failure self-management knowledge yields scores 0-30 which are commonly reported as a percentage (higher scores indicate more knowledge). Content validity was established through a panel of expert heart failure nurses.
Time Frame
At first and final sessions (weeks 1 and 6)
Other Pre-specified Outcome Measures:
Title
Attendance
Description
The number of participants at each meeting will be recorded.
Time Frame
At each weekly session for 6 weeks
Title
Minutes of training
Description
The number of minutes spent in the pre-training session will be recorded.
Time Frame
This will be recorded in the first session at week 1.
Title
Participant Satisfaction
Description
Participants will answer three likert scale questions.
Time Frame
At the final session on week 6
Title
Technology failures
Description
Total number of minutes missed per participant per session.
Time Frame
At each weekly session for 6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of heart failure Receiving home health care from Penn Medicine at Home at time of screening. Technology capabilities to participate in the program (laptop or tablet with a camera, internet access). Able to read and write in English. Cognitive ability to participate in the program if the participant is able to score12/15 on the Montreal Cognitive Assessment (MoCA) 5 Minute Phone Test. Exclusion Criteria: Hearing impairment that impacts communication. Previous experience receiving occupational therapy services from the principal investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Frye, MS OTR/L ATP
Organizational Affiliation
Penn Medicine at Home Professional Development Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Medicine at Home
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32239794
Citation
Butler J, Khan MS, Mori C, Filippatos GS, Ponikowski P, Comin-Colet J, Roubert B, Spertus JA, Anker SD. Minimal clinically important difference in quality of life scores for patients with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Jun;22(6):999-1005. doi: 10.1002/ejhf.1810. Epub 2020 Apr 2.
Results Reference
background
PubMed Identifier
28481824
Citation
Butts B, Higgins M, Dunbar S, Reilly C. The Third Time's a Charm: Psychometric Testing and Update of the Atlanta Heart Failure Knowledge Test. J Cardiovasc Nurs. 2018 Jan/Feb;33(1):13-21. doi: 10.1097/JCN.0000000000000413.
Results Reference
background
PubMed Identifier
10758967
Citation
Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.
Results Reference
background
PubMed Identifier
12867348
Citation
Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
Results Reference
background
PubMed Identifier
11769298
Citation
Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.
Results Reference
background
PubMed Identifier
25091546
Citation
Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014 Nov;67(11):1265-73. doi: 10.1016/j.jclinepi.2014.06.009. Epub 2014 Aug 3.
Results Reference
background
PubMed Identifier
18165909
Citation
Spertus JA, Jones PG, Kim J, Globe D. Validity, reliability, and responsiveness of the Kansas City Cardiomyopathy Questionnaire in anemic heart failure patients. Qual Life Res. 2008 Mar;17(2):291-8. doi: 10.1007/s11136-007-9302-5. Epub 2007 Dec 29.
Results Reference
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Heart Smart: A Virtual Self-Management Program for Homebound People With Heart Failure

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