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

NCT03167996 | Completed

• 1 other identifier: 36464
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

South Asian; Cardiovascular Risk Reduction; Metabolic Disorders; Lifestyle modifications

Outcome Measures

Primary Outcomes (6)

• Change in exercise activity over 6 months

  Patients are given exercise recommendations (or physical activity goals depending on the patient's capacity for exercise) at the time of the initial visit by the HealthPals health coach. The patients will input their activity into the HealthPals platform at time points of their convenience during their 6 month involvement in the study, and this data will be securely aggregated within the platform. The HealthPals health coach who has access to this data will compile and analyze the data and also send it back to the patients' providers by means of final health reports, assessing the change of exercise activity over the duration of the patient's involvement in the study.

  6 months or through study completion

• Measuring medication compliance

  The patients will input their compliance to their medication regimen into the HealthPals platform at time points of their convenience, and this data will be securely aggregated within the platform. The HealthPals health coach who has access to this data will compile and analyze the data and also send it back to the patients' providers by means of final reports.

  Monthly assessment and report for duration of their involvement in the study

• Measuring trends in Blood Pressure measurements

  The patients will input their blood pressure in mmHg at time points of their convenience into the HealthPals platform, and this data will be securely aggregated within the platform. The HealthPals health coach who has access to this data will compile and analyze the data and also send it back to the patients' providers by means of monthly health reports.

  Monthly assessment and report for duration of their involvement in the study

• Measuring trends in weight measurements

  The patients will input their weight in kg at time points of their convenience into the HealthPals platform, and this data will be securely aggregated within the platform. The HealthPals health coach who has access to this data will compile and analyze the data and also send it back to the patients' providers by means of monthly health reports.

  Monthly assessment and report for duration of their involvement in the study

• Measuring compliance to dietary recommendations

  Patients are given dietary recommendations at the time of their initial visit by the HealthPals health coach. After the first visit the patients will input their diet into the HealthPals platform at time points of their convenience, and this data will be securely aggregated within the platform. The HealthPals health coach who has access to this data will compile and analyze the data and also send it back to the patients' providers by means of monthly health reports.

  Monthly assessment and report for duration of their involvement in the study

• Initial User Assessment

  Questionnaire covering personal history, family history, typical diet, exercise and activity, and stress level quantification. This questionnaire is used for a baseline analysis of the patients' health status by the HealthPals health coach.

  Questionnaire administered at time of initial visit

Study Arms (2)

Group B/ HealthPals

EXPERIMENTAL

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

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

Group A/ Control

NO INTERVENTION

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

Interventions

Use of HealthPals (Telemedicine supported by digital health platform) BEHAVIORAL

HealthPals is a smartphone-based chronic disease management mobile application. It uses the mobile health capabilities of smartphones to provide a secure communication portal for patients with their Care Teams to help achieve cardiovascular risk reduction through a digital health coach-based coaching for lifestyle and medication compliance. The HealthPals app was developed by HealthPals, Inc.

Group B/ HealthPals

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• adult smartphone users

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• HealthPals, Inc: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Prediabetic State; Diabetes Mellitus; Coronary Artery Disease; Hypertension; Prehypertension; Dyslipidemias; Metabolic Diseases

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Lipid Metabolism Disorders

Study Officials

• Fahim Abbasi, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Shriram Nallamshetty, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor (Affiliated) [VAPAHCS]

Model Details: Group A Control Group B HealthPals

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 30, 2017
• Study Start: June 23, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 23, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)