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Virtual Care Strategies to Improve Participation in Cardiac Rehabilitation Among Veterans (IMPACT)

Primary Purpose

Cardiovascular Diseases

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
d-Coaching
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Cardiovascular Diseases, Cardiac Rehabilitation, Telemedicine, Telerehabilitation, Veterans

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 50 years of age
  2. History of cardiovascular disease that qualified participant for CR (MI, percutaneous coronary intervention, coronary artery bypass grafting, heart failure, valve surgery)
  3. Referral to participate in home-based Phase II CR.

Exclusion Criteria:

  1. Participation in center-based Phase II CR.
  2. Cognitive impairment (per Mini-Cog)
  3. Lack of English proficiency/literacy (Digital coaching will be conducted in English. Participants will need to speak/read English to receive intervention.)
  4. Unstable clinical conditions (e.g., unstable arrhythmias or heart block, active infection, uncontrolled hypertension, decompensated heart failure, unstable angina, etc.)

Sites / Locations

  • San Francisco VA Medical Center, San Francisco, CARecruiting
  • Atlanta VA Medical and Rehab Center, Decatur, GA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

d-Coaching

Usual Care

Arm Description

Will receive home-based cardiac rehabilitation (HBCR) with digital coaching (d-Coaching) intervention

Will receive home-based cardiac rehabilitation (HBCR) alone

Outcomes

Primary Outcome Measures

HBCR sessions
Number of completed home-based cardiac rehabilitation sessions

Secondary Outcome Measures

Step count
Measured by Fitbit
Functional capacity
6-minute walk test
Sedentary time
Measured by Fitbit

Full Information

First Posted
June 14, 2022
Last Updated
March 17, 2023
Sponsor
VA Office of Research and Development
Collaborators
Atlanta VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05423158
Brief Title
Virtual Care Strategies to Improve Participation in Cardiac Rehabilitation Among Veterans
Acronym
IMPACT
Official Title
Virtual Care Strategies to Improve Participation in Cardiac Rehabilitation Among Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Atlanta VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Home-based CR (HBCR) is an alternative to traditional CR programs that has comparable efficacy in improving morbidity/mortality and increases access to critical services. There is major potential to improve Veteran engagement in CR by combining digital coaching (d-Coaching) with existing VA-supported technologies. The investigator's theory-based intervention targets a critical component of successful CR engagement that is not available through traditional programs: virtual social support through a social network. In addition, the investigators propose to improve self-efficacy and self-regulation through interactive digital multi-media education, personalized feedback, and motivation so that Veterans can complete the prescribed HBCR program and maintain physical activity long-term. This RCT will evaluate the effects of HBCR alone (usual care) versus HBCR + d-Coaching, including a private social media group (Movn), optimized Annie text messaging, VA Video Connect, and connected devices (Fitbits). The investigators will randomly assign 150 Veterans from 2 HBCR programs to a 3-month intervention. The addition of d- Coaching to existing digital technologies will be operationalized by using a private social media group to provide social support, education, personalized feedback, and motivation. The investigators aim to determine the effect of the d-Coaching intervention on: a) the number of completed HBCR sessions over 3 months, b) functional capacity, c) physical activity, c) psychosocial outcomes, d) clinical outcomes, and e) social cognitive factors of self-efficacy, self-regulation, and perceived social support over 12 months. The investigators will also evaluate the extent to which self-efficacy, self-regulation, and perceived social support mediate the effect of the intervention on function and physical activity.
Detailed Description
Underutilization of cardiac rehabilitation (CR). Cardiovascular disease (CVD) is the leading cause of mortality for adults in developed countries, including Veterans. Despite the guideline recommendations for cardiac rehabilitation (CR) for patients with qualifying cardiovascular conditions, participation rates have been dismal over the decades without significant improvement, both within VA and non-VA programs. Only 16.3% of Medicare patients and 10.3% of Veterans participated in center-based CR (CBCR) between 2007 and 2011 after hospitalization for MI, percutaneous coronary intervention, or coronary artery bypass graft surgery. Participation in CR is especially low for older adults (Medicare beneficiaries), Veterans, women, and individuals from underserved populations. Completion of CR programs is also a major problem as 24% and 50% of participants drop-out from CR programs. Barriers for CBCR participation and adherence include considerable travel burden, co-pay for non-VHA programs, time away from work, or being the primary caregiver for children or older adults. Home-based CR (HBCR) and hybrid CR programs (combination of CBCR and HBCR) are alternative approaches to promote exercise and provide education that have been traditionally provided in CBCR. HBCR programs have been studied in depth showing equivalency to CBCR without increased adverse events. However, although the provision of HBCR has alleviated some of the barriers related to CBCR participation, barriers to participation in HBCR include: lack of peer social support, safety concerns for patients at higher risk, lack of face-to-face monitoring and communication, and less patient accountability. While completion rates are marginally higher for HBCR programs than center-based programs, less than half (48%) of Veterans participating in the investigator's SFVAMC HBCR program completed at least nine sessions, well above the VA average of 13%. Home-based CR in the VA system. Across the VA, only 28% of VAMCs (35/124) have a CBCR program, and low participation is a significant problem with only 8.4% of Veterans participating in at least one session of CBCR at a VA or non-VA contracted site. A growing number of alternative HBCR and hybrid programs now exist in the VA health system after a recent initiative by the Office of Rural health (ORH) to sponsor the expansion of 30 alternative programs nationally. In addition, there have been accelerated efforts by VA CBCR programs to improve access to CR services remotely (equivalent to HBCR) due to the limits on in-person care from the COVID-19 pandemic. VA program evaluations have shown Veterans preferred HBCR compared to CBCR, and Veterans hospitalized at a facility with a HBCR program were 3 to 4 times more likely to participate in HBCR compared to any CBCR program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases
Keywords
Cardiovascular Diseases, Cardiac Rehabilitation, Telemedicine, Telerehabilitation, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
The investigators propose a randomized clinical trial evaluating the effects of HBCR alone (usual care) versus HBCR + d-Coaching. d-Coaching includes a private social media group, optimized Annie text messaging, VA Video Connect, and a wearable device.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
d-Coaching
Arm Type
Experimental
Arm Description
Will receive home-based cardiac rehabilitation (HBCR) with digital coaching (d-Coaching) intervention
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Will receive home-based cardiac rehabilitation (HBCR) alone
Intervention Type
Behavioral
Intervention Name(s)
d-Coaching
Other Intervention Name(s)
Digital Coaching
Intervention Description
MOVN mobile app: Each participant will be assigned a secure login account that does not include personal information for research only. Participants will be trained on how to access and use the MOVN private social network group. Annie text messaging: Participants will be registered in the Annie VA text messaging program to receive tailored, interactive "push" messages with a combination of 1 and 2-way tailored messages on goals, barriers, self-management, etc. (based on data collected in real-time from the Fitbit and barriers identified at baseline). Fitbit wearable device & mobile app: The intervention group will be instructed to use the Fitbit for step counts and maximizing the Fitbit mobile app/desktop platform to track all PA, sharing one's Fitbit profile with others (optional leaderboard), and use of all available features.
Primary Outcome Measure Information:
Title
HBCR sessions
Description
Number of completed home-based cardiac rehabilitation sessions
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Step count
Description
Measured by Fitbit
Time Frame
3 months
Title
Functional capacity
Description
6-minute walk test
Time Frame
3 months
Title
Sedentary time
Description
Measured by Fitbit
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 50 years of age History of cardiovascular disease that qualified participant for CR (MI, percutaneous coronary intervention, coronary artery bypass grafting, heart failure, valve surgery) Referral to participate in home-based Phase II CR. Exclusion Criteria: Participation in center-based Phase II CR. Cognitive impairment (per Mini-Cog) Lack of English proficiency/literacy (Digital coaching will be conducted in English. Participants will need to speak/read English to receive intervention.) Unstable clinical conditions (e.g., unstable arrhythmias or heart block, active infection, uncontrolled hypertension, decompensated heart failure, unstable angina, etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda G Park, PhD MS NP
Phone
(925) 348-2174
Email
Linda.Park@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Julia von Oppenfeld, BA
Phone
(415) 676-1153
Email
Julia.vonoppenfeld@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Grace Park, PhD MS NP
Organizational Affiliation
San Francisco VA Medical Center, San Francisco, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joe R. Nocera, PhD
Organizational Affiliation
Atlanta VA Medical and Rehab Center, Decatur, GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco VA Medical Center, San Francisco, CA
City
San Francisco
State/Province
California
ZIP/Postal Code
94121-1563
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda G Park, PhD MS NP
Phone
(925) 348-2174
Email
Linda.Park@va.gov
First Name & Middle Initial & Last Name & Degree
Linda Grace Park, PhD MS NP
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033-4004
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joe R Nocera, PhD
Phone
404-321-6111
Ext
6354
Email
joe.nocera2@va.gov
First Name & Middle Initial & Last Name & Degree
Joe R. Nocera, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Care Strategies to Improve Participation in Cardiac Rehabilitation Among Veterans

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