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

Hypertension Clinical Trial

— HealthPals  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167996
• Other study ID #: 36464
• Status: Completed
• Phase: N/A
• Start date: June 23, 2016
• Est. completion date: March 23, 2018

Study information

• Verified date: February 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 23, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Coronary Artery Disease
• Coronary Disease
• Diabetes
• Dyslipidemias
• Hypertension
• Insulin Resistance
• Myocardial Ischemia
• PreDiabetes
• Prediabetic State
• Prehypertension

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	HealthPals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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