PERsonal ContExtual Precision healTh (PERCEPT)

Personal Mobile and Contextual Precision Health

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.

Study Overview

• Status: Completed
• Conditions: Depression; Hypertension
• Intervention / Treatment: Behavioral: Mobile Health Monitoring

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Primary care patient at UCD or UCSF
2. Able to speak and read English
3. Male or female 18-80 years of age at Telephone screening
4. 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
5. 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
6. Have an Android or Apple iOS smartphone
7. Willing to install the PERCEPT, iHealth (for hypertension cohort) and Moves mobile applications
8. 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
9. Willing to be have your location and activity tracked
10. 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
11. Have home Wifi access.

Exclusion Criteria:

1. High blood pressure or depression being managed by a physician outside of UCD or UCSF
2. Current participation in any other mobile app-based clinical study
3. A diagnosis of both hypertension and depression
4. 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)
5. Planning to relocate from area within the study duration
6. Impaired vision that could limit the use of the mobile apps (participant-reported)
7. Primary care patient of the Investigator, Dr. Meghana Gadgil

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mobile Health Monitoring; 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.

Behavioral: Mobile Health Monitoring; Use of mobile health application to monitor blood pressure and mood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitoring health condition	Instances of recording blood pressure or mood in mobile health application compared with notification frequency	3 months and 6 month

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: University of California, Davis; California Initiative to Advance Precision Medicine
• Investigators: Principal Investigator: Meghana D Gadgil, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Cardiovascular Diseases; Vascular Diseases; Depression; Hypertension
• Other Study ID Numbers: PERCEPT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No