search
Back to results

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

Primary Purpose

Cardiovascular Risk Factor, Insulin Resistance, PreDiabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of HealthPals (Telemedicine supported by digital health platform)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Risk Factor focused on measuring South Asian, Cardiovascular Risk Reduction, Metabolic Disorders, Lifestyle modifications

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group B/ HealthPals

Group A/ Control

Arm 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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 15, 2017
Last Updated
February 12, 2019
Sponsor
Stanford University
Collaborators
HealthPals, Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT03167996
Brief Title
Chronic Cardiovascular Risk Outpatient Management in South Asians Using Digital Health Technology
Acronym
HealthPals
Official Title
Chronic Cardiovascular Risk Outpatient Management in South Asians Using Digital Health Technology
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 23, 2016 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
HealthPals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Insulin Resistance, PreDiabetes, Diabetes, Coronary Artery Disease, Hypertension, Prehypertension, Dyslipidemias
Keywords
South Asian, Cardiovascular Risk Reduction, Metabolic Disorders, Lifestyle modifications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A Control Group B HealthPals
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group B/ HealthPals
Arm Type
Experimental
Arm 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
Arm Title
Group A/ Control
Arm Type
No Intervention
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Use of HealthPals (Telemedicine supported by digital health platform)
Intervention Description
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 Outcome Measure Information:
Title
Change in exercise activity over 6 months
Description
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.
Time Frame
6 months or through study completion
Title
Measuring medication compliance
Description
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.
Time Frame
Monthly assessment and report for duration of their involvement in the study
Title
Measuring trends in Blood Pressure measurements
Description
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.
Time Frame
Monthly assessment and report for duration of their involvement in the study
Title
Measuring trends in weight measurements
Description
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.
Time Frame
Monthly assessment and report for duration of their involvement in the study
Title
Measuring compliance to dietary recommendations
Description
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.
Time Frame
Monthly assessment and report for duration of their involvement in the study
Title
Initial User Assessment
Description
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.
Time Frame
Questionnaire administered at time of initial visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fahim Abbasi, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shriram Nallamshetty, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs