PERsonal ContExtual Precision healTh (PERCEPT)
Primary Purpose
Hypertension, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Health Monitoring
Sponsored by

About this trial
This is an interventional other trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Primary care patient at UCD or UCSF
- Able to speak and read English
- Male or female 18-80 years of age at Telephone screening
- Documentation of a diagnosis of hypertension (defined as SBP >= 140 mmHg or DBP >= 90 mmHg on anti-hypertensive medication including beta-blockers, ACE-I, ARB, alpha-blockers, calcium-channel blockers) OR depression (PHQ-8 > 5) on an antidepressant medication
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
- Have an Android or Apple iOS smartphone
- Willing to install the PERCEPT, iHealth (for hypertension cohort) and Moves mobile applications
- Willing to self-report blood pressure (for those with hypertension and with provided iHealth and/or standard blood pressure cuff) or mood data (for those with depression) at specified frequency
- Willing to be have your location and activity tracked
- Have downloaded a mobile application from the appropriate mobile app store (App store for iPhones or Google Play for Android) within the past 1 year
- Have home Wifi access.
Exclusion Criteria:
- High blood pressure or depression being managed by a physician outside of UCD or UCSF
- Current participation in any other mobile app-based clinical study
- A diagnosis of both hypertension and depression
- A diagnosis of depression with psychosis (ICD-9: 296.24, 296.34) bipolar disorder (ICD-9: 296.0, 296.1, 296.4, 296.5, 296.6, 296.7, 296.8, 296.9) schizophrenia (ICD-9: 295.x), schizoaffective disorder (ICD-9 295.70)
- Planning to relocate from area within the study duration
- Impaired vision that could limit the use of the mobile apps (participant-reported)
- Primary care patient of the Investigator, Dr. Meghana Gadgil
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mobile Health Monitoring
Arm Description
Participants will monitor their blood pressure using a wireless-enabled blood pressure cuff or mood using a mobile health application once per week at baseline. The investigators will monitor their medical records to determine if a medication change has occurred. After this, the investigators will increase the frequency of notifications to monitor the participant's specific health condition to once daily for 1 month. This monitoring will continue for a study duration of 6 months.
Outcomes
Primary Outcome Measures
Capture medication transition data from electronic health record
Number of medication changes captured in our system vs. the number reported by participants at the end of the study
Secondary Outcome Measures
Monitoring health condition
Instances of recording blood pressure or mood in mobile health application compared with notification frequency
Full Information
NCT ID
NCT03349918
First Posted
November 17, 2017
Last Updated
March 4, 2019
Sponsor
University of California, San Francisco
Collaborators
University of California, Davis, California Initiative to Advance Precision Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03349918
Brief Title
PERsonal ContExtual Precision healTh
Acronym
PERCEPT
Official Title
Personal Mobile and Contextual Precision Health
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of California, Davis, California Initiative to Advance Precision Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The exponential growth of physiological, behavioral and environmental data generated through consumer mobile health (mHealth) devices and Internet of Things (IoT) technology provide unprecedented sources of personalized and contextual health information. If linked to clinical health data from the Electronic Health Record (EHR), these data can provide dynamic and individualized views of patient health states and trajectories that can greatly inform clinical care and health-related research. The investigators propose to advance precision health through the development and evaluation of a mobile application and data platform that collects, harmonizes and integrates mHealth and environmental data from patients' daily lives with their clinical histories and electronic health record data.
The investigators propose a participatory design approach to implement and evaluate a precision health platform through the study and modeling of hypertension (HTN) and depression in patient communities of UC Davis (UCD) and UC San Francisco (UCSF). These chronic diseases have high prevalence across geography, socioeconomic status, and race/ethnicity, and have significant economic, societal and personal costs. They are considerably challenging to manage due to difficulties in acquiring high-quality and consistent data from patients outside of their clinical care appointments that is so needed for a full view of the patient's disease state. Despite a broad array of self-monitoring devices and consumer applications, mHealth data are not getting into the clinical care process, and patients do not regularly monitor their own health states, particularly during periods of medication change, when frequent assessments are especially important.
The investigators propose to conduct a 6-month single arm feasibility study of 200 ambulatory men and women (100 each at UCSF and UCD) with either hypertension or depression to implement an open, web-accessible, standards driven and patient-centric data platform for the integration of patient-reported and clinical data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Depression
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile Health Monitoring
Arm Type
Experimental
Arm Description
Participants will monitor their blood pressure using a wireless-enabled blood pressure cuff or mood using a mobile health application once per week at baseline. The investigators will monitor their medical records to determine if a medication change has occurred. After this, the investigators will increase the frequency of notifications to monitor the participant's specific health condition to once daily for 1 month. This monitoring will continue for a study duration of 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Health Monitoring
Intervention Description
Use of mobile health application to monitor blood pressure and mood.
Primary Outcome Measure Information:
Title
Capture medication transition data from electronic health record
Description
Number of medication changes captured in our system vs. the number reported by participants at the end of the study
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Monitoring health condition
Description
Instances of recording blood pressure or mood in mobile health application compared with notification frequency
Time Frame
3 months and 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary care patient at UCD or UCSF
Able to speak and read English
Male or female 18-80 years of age at Telephone screening
Documentation of a diagnosis of hypertension (defined as SBP >= 140 mmHg or DBP >= 90 mmHg on anti-hypertensive medication including beta-blockers, ACE-I, ARB, alpha-blockers, calcium-channel blockers) OR depression (PHQ-8 > 5) on an antidepressant medication
Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Have an Android or Apple iOS smartphone
Willing to install the PERCEPT, iHealth (for hypertension cohort) and Moves mobile applications
Willing to self-report blood pressure (for those with hypertension and with provided iHealth and/or standard blood pressure cuff) or mood data (for those with depression) at specified frequency
Willing to be have your location and activity tracked
Have downloaded a mobile application from the appropriate mobile app store (App store for iPhones or Google Play for Android) within the past 1 year
Have home Wifi access.
Exclusion Criteria:
High blood pressure or depression being managed by a physician outside of UCD or UCSF
Current participation in any other mobile app-based clinical study
A diagnosis of both hypertension and depression
A diagnosis of depression with psychosis (ICD-9: 296.24, 296.34) bipolar disorder (ICD-9: 296.0, 296.1, 296.4, 296.5, 296.6, 296.7, 296.8, 296.9) schizophrenia (ICD-9: 295.x), schizoaffective disorder (ICD-9 295.70)
Planning to relocate from area within the study duration
Impaired vision that could limit the use of the mobile apps (participant-reported)
Primary care patient of the Investigator, Dr. Meghana Gadgil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghana D Gadgil, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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PERsonal ContExtual Precision healTh
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