Chronic Cardiovascular Risk Outpatient Management in South Asians Using Digital Health Technology (HealthPals)

Stanford University

Status: Completed

Conditions: Hypertension; Coronary Artery Disease; Prehypertension; Diabetes; Dyslipidemias; Insulin Resistance; Cardiovascular Risk Factor; PreDiabetes

Treatments: Behavioral: Use of HealthPals (Telemedicine supported by digital health platform)

Study type: Interventional

Funder types: Other

Identifiers

NCT03167996

36464

Details and patient eligibility

About

This platform will enable investigation the cardiovascular risk reduction and the increase in participant engagement in their heart-healthy goals, through the use of virtual care/telemedicine with a digital platform that connects them to their own doctors, nurses, and dietitians.

Full description

The study will use telemedicine and the mobile health capabilities of smartphones to facilitate communication of medical goals set by the treating physician to the subject in between clinic visits, and to assess the daily medical and lifestyle change compliance of enrolled Stanford subjects and provide virtual health coaching, as needed, to subjects to achieve said goals. How patients comply with their specific medical and lifestyle goals all affect their cardiovascular health, yet largely go unmeasured. These can now be measured with a notification-based system in which subject-entered activity, medication compliance, and dietary reporting data will be collected, assessed, and trigger appropriate responses by the subject's Care Team, which includes their physician, nurse, dietitian, and assigned health coach. We aim to collect this subject-reported activity and cardiovascular care plan compliance data to provide much more quantitative data on type, duration, and intensity of daily activities and compliance with the medication regimens of enrolled subjects.

The study will compare anthropometric cardiovascular risk biomarkers testing at the initial visit and after 3 months, in subjects utilizing the HealthPals digital platform PLUS the standard SSATHI clinic visits, versus subjects receiving only SSATHI clinic visits.

Enrollment: 38 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adult smartphone users

Exclusion criteria

• Subjects who do not own a smartphone or cannot access their mobile health data
• Patients unable to read English, as the initial version of the research app will be in English
• Participants who are children (under 18 years old)
• Participants who are pregnant women
• Participants who are economically and educationally disadvantaged, decisionally impaired, homeless people, or employees of Stanford University will be excluded due to being of a vulnerable population.
• Participants who express active chest pain or shortness of breath in their first clinic visit and are clinically deemed to require an emergency room evaluation will be excluded
• Participants who have inability or unwillingness to use or connect to data services for app messaging
• Participants with an upcoming surgical procedure (for instance, a clinic visit as part of preoperative evaluation) that will significantly impair or block their ability to follow the chronic disease management program during the study period
• Participants who have pre-existing participation in another clinical research protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Group B/ HealthPals

Experimental group

Description:

Group B have access to HealthPals app where they will coordinate with a trained health coach Group B patients will only come into SSATHI clinic to see their doctor for an initial visit and 6 month follow up, and they will have a telephone visit with their doctor at 3 months instead of an in-clinic visit Lab testing is the same for both Group A/ control and Group B patients

Treatment:

Behavioral: Use of HealthPals (Telemedicine supported by digital health platform)

Group A/ Control

No Intervention group

Description:

Group B will not have access to HealthPals app Group A patients will come into SSATHI clinic to see their doctor for an initial visit, a 3 month follow up, and a 6 month follow up Lab testing is the same for both Group A/ control and Group B patients