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Completed

NCT Number: NCT05057364

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine at Home

Bala-Cynwyd, Pennsylvania, 19004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heart Smart Virtual Self-Management Group

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Attendance

    Time frame: At each weekly session for 6 weeks

    The number of participants at each meeting will be recorded.

  2. 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.

  3. Participant Satisfaction

    Time frame: At the final session on week 6

    Participants will answer three likert scale questions.

  4. Technology failures

    Time frame: At each weekly session for 6 weeks.

    Total number of minutes missed per participant per session.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2021
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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