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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05057364
• Other study ID #: 849646
• Status: Completed
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

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.

Locations

Country	Name	City	State
United States	Penn Medicine at Home	Bala-Cynwyd	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View Citation

Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Attendance	The number of participants at each meeting will be recorded.	At each weekly session for 6 weeks
Other	Minutes of training	The number of minutes spent in the pre-training session will be recorded.	This will be recorded in the first session at week 1.
Other	Participant Satisfaction	Participants will answer three likert scale questions.	At the final session on week 6
Other	Technology failures	Total number of minutes missed per participant per session.	At each weekly session for 6 weeks.
Primary	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.	At first and final sessions (weeks 1 and 6)
Secondary	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.	At first and final sessions (weeks 1 and 6)
Secondary	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.	At first and final sessions (weeks 1 and 6)