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OpenTrials
Completed

NCT Number: NCT03167996

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

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.

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Key information

Conditions

Cardiovascular Risk Factor Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hyperinsulinism Hypertension Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases PreDiabetes Prediabetic State Prehypertension Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in exercise activity over 6 months

    Time frame: 6 months or through study completion

    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.

  2. Measuring medication compliance

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

    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.

  3. Measuring trends in Blood Pressure measurements

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

    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.

  4. Measuring trends in weight measurements

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

    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.

  5. Measuring compliance to dietary recommendations

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

    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.

  6. Initial User Assessment

    Time frame: Questionnaire administered at time of initial visit

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • HealthPals, Inc

Registry information

Acronym: HealthPals

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 30, 2017
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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