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

NCT05057364 | Completed

• 1 other identifier: 849646
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart failure; telehealth; occupational therapy; self-management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)

  At first and final sessions (weeks 1 and 6)

• Change in Atlanta Heart Failure Knowledge Test V3 (AHFKT)

  At first and final sessions (weeks 1 and 6)

Other Outcomes (4)

• Attendance

  At each weekly session for 6 weeks

• Minutes of training

  This will be recorded in the first session at week 1.

• Participant Satisfaction

  At the final session on week 6

Study Arms (1)

Heart Smart Group

EXPERIMENTAL

Receives Heart Smart Intervention

Other: Heart Smart Virtual Self-Management Group

Interventions

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.

Heart Smart Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine at Home

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Related 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.

  PMID: 32239794 BACKGROUND

• 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.

  PMID: 28481824 BACKGROUND

• 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.

  PMID: 10758967 BACKGROUND

• 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.

  PMID: 12867348 BACKGROUND

• 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.

  PMID: 11769298 BACKGROUND

• 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.

  PMID: 25091546 BACKGROUND

• 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.

  PMID: 18165909 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sara Frye, MS OTR/L ATP

  Penn Medicine at Home Professional Development Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Therapy Professional Development Specialist

Model Details: Pilot study, single group, no control. pre-post data collection

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 27, 2021
• Study Start: September 28, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)