Clinical trial NCT03167996: Chronic Cardiovascular Risk Outpatient Management in South Asians Using Digital Health Technology
Official title: Chronic Cardiovascular Risk Outpatient Management in South Asians Using Digital Health Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Insulin Resistance
PreDiabetes
Diabetes
Coronary Artery Disease
Hypertension
Prehypertension
Dyslipidemias
Keywords: South Asian
Cardiovascular Risk Reduction
Metabolic Disorders
Lifestyle modifications
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: HealthPals, Inc
First posted: 2017-05-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A Control Group B HealthPals
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in exercise activity over 6 months
timeFrame: 6 months or through study completion
measure: Measuring medication compliance
timeFrame: Monthly assessment and report for duration of their involvement in the study
measure: Measuring trends in Blood Pressure measurements
timeFrame: Monthly assessment and report for duration of their involvement in the study
measure: Measuring trends in weight measurements
timeFrame: Monthly assessment and report for duration of their involvement in the study
measure: Measuring compliance to dietary recommendations
timeFrame: Monthly assessment and report for duration of their involvement in the study
measure: Initial User Assessment
timeFrame: Questionnaire administered at time of initial visit
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Fahim Abbasi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Shriram Nallamshetty, MD
role: PRINCIPAL_INVESTIGATOR
References: