PERsonal ContExtual Precision healTh (PERCEPT)

March 4, 2019 updated by: University of California, San Francisco

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Capture medication transition data from electronic health record
Time Frame: 24 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Monitoring health condition
Time Frame: 3 months and 6 month
Instances of recording blood pressure or mood in mobile health application compared with notification frequency
3 months and 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, Davis
California Initiative to Advance Precision Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meghana D Gadgil, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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