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

March 7, 2022 updated by: Sara Frye, MS OTR/L ATP, University of Pennsylvania
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Penn Medicine at Home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heart Smart Group
Receives Heart Smart Intervention
Other: Heart Smart Virtual Self-Management Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self-Efficacy Measure for Chronic Disease (SEMCD)
Time Frame: At first and final sessions (weeks 1 and 6)
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.
At first and final sessions (weeks 1 and 6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: At first and final sessions (weeks 1 and 6)
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.
At first and final sessions (weeks 1 and 6)
Change in Atlanta Heart Failure Knowledge Test V3 (AHFKT)
Time Frame: At first and final sessions (weeks 1 and 6)
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.
At first and final sessions (weeks 1 and 6)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance
Time Frame: At each weekly session for 6 weeks
The number of participants at each meeting will be recorded.
At each weekly session for 6 weeks
Minutes of training
Time Frame: This will be recorded in the first session at week 1.
The number of minutes spent in the pre-training session will be recorded.
This will be recorded in the first session at week 1.
Participant Satisfaction
Time Frame: At the final session on week 6
Participants will answer three likert scale questions.
At the final session on week 6
Technology failures
Time Frame: At each weekly session for 6 weeks.
Total number of minutes missed per participant per session.
At each weekly session for 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Sara Frye, MS OTR/L ATP, Penn Medicine at Home Professional Development Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 849646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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