d-Coaching for Cardiovascular Diseases

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
San Francisco VA Medical Center, San Francisco, CA, San Francisco, CA
Cardiovascular Diseases
d-Coaching - Behavioral
Eligibility
18+
All Sexes
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cardiovascular Diseases

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 3 months

3 months
Functional capacity
HBCR sessions
Sedentary time
Step count

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Cardiovascular Diseases

Trial Design

2 Treatment Groups

Usual Care
1 of 2
d-Coaching
1 of 2
Active Control
Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: d-Coaching · No Placebo Group · Phase 2

d-Coaching
Behavioral
Experimental Group · 1 Intervention: d-Coaching · Intervention Types: Behavioral
Usual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
Closest Location: San Francisco VA Medical Center, San Francisco, CA · San Francisco, CA
Photo of San Francisco 1Photo of San Francisco 2Photo of San Francisco 3
2007First Recorded Clinical Trial
1 TrialsResearching Cardiovascular Diseases
33 CompletedClinical Trials

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,459 Previous Clinical Trials
2,748,763 Total Patients Enrolled
35 Trials studying Cardiovascular Diseases
81,327 Patients Enrolled for Cardiovascular Diseases
Atlanta VA Medical CenterFED
23 Previous Clinical Trials
69,242 Total Patients Enrolled
1 Trials studying Cardiovascular Diseases
300 Patients Enrolled for Cardiovascular Diseases
Linda Grace Park, PhD MS NPPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA
Joe R. Nocera, PhDPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA
3 Previous Clinical Trials
206 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.