Cardiovascular Risk FactorHealthPalsNCT03167996
Chronic Cardiovascular Risk Outpatient Management in South Asians Using Digital Health Technology
A study testing Use of HealthPals (Telemedicine supported by digital health platform) in people with Cardiovascular Risk Factor and Insulin Resistance, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Insulin Resistance, PreDiabetes
- What is being tested?
- Use of HealthPals (Telemedicine supported by digital health platform)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2016to 23 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult smartphone users
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Risk Factor, Insulin Resistance, PreDiabetes, Diabetes, Coronary Artery Disease, Hypertension
- Being tested
- Use of HealthPals (Telemedicine supported by digital health platform)
- Keywords
- South Asian, Cardiovascular Risk Reduction, Metabolic Disorders, Lifestyle modifications
- Medical subject headings
- Insulin Resistance, Prediabetic State, Diabetes Mellitus, Coronary Artery Disease, Hypertension, Prehypertension, Dyslipidemias, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of HealthPals (Telemedicine supported by digital health platform)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Questionnaire administered at time of initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start23 Jun 2016
- Primary completion1 Mar 2018
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A Control Group B HealthPals
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- HealthPals, Inc
- Responsible party
- Principal investigator, Shriram Nallamshetty, Stanford University
- Investigators
- Fahim Abbasi, MD, Principal investigator, Stanford UniversityShriram Nallamshetty, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167996
- Sponsor's protocol ID
- 36464
- Acronym
- HealthPals
- Status last verified
- Feb 2019
- First submitted
- 15 May 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Cardiovascular Risk Outpatient Management in South Asians Using Digital Health Technology
- ClinicalTrials.gov ID
- NCT03167996
- Acronym / sponsor ID
- HealthPals / 36464
- Conditions
- Cardiovascular Risk Factor, Insulin Resistance, PreDiabetes, Diabetes, Coronary Artery Disease, Hypertension
- Keywords
- South Asian, Cardiovascular Risk Reduction, Metabolic Disorders, Lifestyle modifications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- HealthPals, Inc
- Study start
- 23 Jun 2016 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A Control Group B HealthPals
| Arm | Type | Receives |
|---|---|---|
| Group B/ HealthPals | Experimental | Behavioral: Use of HealthPals (Telemedicine supported by digital health platform)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 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adult smartphone users
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group B/ HealthPals |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fahim Abbasi, MD principal investigator
Stanford University
Shriram Nallamshetty, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of HealthPals (Telemedicine supported by digital health platform) in people with Cardiovascular Risk Factor and Insulin Resistance, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in exercise activity over 6 months (time frame: 6 months or through study completion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.