Clinical trial NCT05057364: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
telehealth
occupational therapy
self-management
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study, single group, no control. pre-post data collection
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Self-Efficacy Measure for Chronic Disease (SEMCD)
timeFrame: At first and final sessions (weeks 1 and 6)
Secondary outcomes:
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: At first and final sessions (weeks 1 and 6)
measure: Change in Atlanta Heart Failure Knowledge Test V3 (AHFKT)
timeFrame: At first and final sessions (weeks 1 and 6)
Other outcomes:
measure: Attendance
timeFrame: At each weekly session for 6 weeks
measure: Minutes of training
timeFrame: This will be recorded in the first session at week 1.
measure: Participant Satisfaction
timeFrame: At the final session on week 6
measure: Technology failures
timeFrame: At each weekly session for 6 weeks.
Locations:
city: Bala-Cynwyd
country: United States
facility: Penn Medicine at Home
state: Pennsylvania
Study officials:
affiliation: Penn Medicine at Home Professional Development Department
name: Sara Frye, MS OTR/L ATP
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.