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Mobile Self-Tracking

Primary Purpose

Schizophrenia, Bipolar Disorder, Schizoaffective Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mobile application
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia focused on measuring Mental health care, Informatics, Predictive Modeling, Bipolar disorder, Psychotic Disorders, Machine learning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veteran patient at the Greater Los Angeles Veterans Healthcare Center with a chart diagnosis of serious mental illness, defined as a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
  • Risk for symptoms based on having had, during the past year, psychiatric hospitalization, psychiatric emergency care, lived at a crisis program, or more than 6 outpatient visits; and,
  • Ownership of a smartphone with a data plan

Exclusion Criteria:

  • Under age 18
  • Has a conservator/legally authorized representative

Sites / Locations

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CARecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mobile application

Arm Description

Participants use a mobile application on their smartphone

Outcomes

Primary Outcome Measures

Feasibility of passive self-tracking of mental health change
Feasibility of passive self-tracking of mental health assessed using qualitative interview data based on the Technology Assessment Model.
Estimates of sociability
Use mobile sensor and phone utilization data to develop individualized estimates of sociability.
Identify exacerbations of psychiatric symptoms
Study the predictive value of using data on sociability, activities, and sleep to identify exacerbations of psychiatric symptoms.
Acceptability of passive self-tracking of mental health change
Acceptability of passive self-tracking of mental health assessed using qualitative interview data based on the Technology Assessment Model.
Safety of passive self-tracking of mental health change
Safety of passive self-tracking of mental health assessed using the occurrence of serious adverse events.
Estimates of activities
Use mobile sensor and phone utilization data to develop individualized estimates of activities.
Estimates of sleep
Use mobile sensor and phone utilization data to develop individualized estimates of sleep.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2021
Last Updated
August 2, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05023252
Brief Title
Mobile Self-Tracking
Official Title
Passive Mobile Self-Tracking of Mental Health by Veterans With Serious Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Serious mental illnesses require years of monitoring and adjustments in treatment. Stress, substance abuse or reduced medication adherence cause rapid worsening of symptoms, with consequences that include job loss, homelessness, suicide, incarceration, and hospitalization. Treatment visits can be infrequent. Illness exacerbations usually occur with no clinician awareness, leaving little opportunity to make treatment adjustments. Tools are needed that quickly detect illness worsening. At least two thirds of Veterans with serious mental illness use a smart phone. These phones generate data that characterize sociability, activity and sleep. Changes in these are warning signs for relapse. Members of this project developed an app that monitors and transmits these mobile data. This project studies passive mobile sensing that allows Veterans to self-track their activities, sociability and sleep; and studies whether this can be used to track symptoms. The project intends to produce a mobile platform that monitors the clinical status of patients, identifies risk for relapse, and allows early intervention.
Detailed Description
Background: Serious mental illnesses are common, disabling, challenging to treat, and require years of monitoring with adjustments in treatments. Stress or reduced medication adherence can lead to rapid worsening in symptoms and functioning with consequences that include relapse, job loss, homelessness, incarceration, hospitalization and suicide. In usual care, clinician visits are infrequent, with intervals ranging from monthly to yearly. Communication between patients and clinicians between visits is challenging and often nonexistent. Patient illness exacerbations and relapses generally occur with little or no clinician awareness in real time, leaving little opportunity to adjust treatments. Significance/Impact: For the large population of Veterans with serious mental illness, tools are needed that passively monitor their mental health status, allowing them to self-track their behaviors, quickly detect worsening of mental health, and support prompt assessment and intervention. At least 60% of Veterans with serious mental illness use a smart phone. These generate data that characterize sociability, activity, and sleep. Changes in these behaviors are warning signs of relapse. Passive self-tracking could be used to identify and predict worsening of illness in real time. Innovation: Passive mobile sensing is a novel approach to illness self-tracking and monitoring. There has been relatively little research on passive self-tracking in serious mental illness, with limited analytics development in this area, and none in VA. Specific Aims: This project studies passive mobile sensing with Veterans in treatment for serious mental illness. Data are used for self-tracking of behaviors and symptoms. While passive mobile sensing has been feasible, acceptable and safe in patients with serious mental illness, these are studied for the first time in VA. Analytics are developed that use passive data to predict behaviors and symptoms. This project responds to the HSR&D priority areas of Mental Health and Healthcare Informatics. The project has these objectives: Conduct user-centered design of passive mobile self-tracking to support Veterans' management of their mental health. Study the feasibility, acceptability and safety of passive self-tracking of mental health that includes feedback of mental health status to the Veteran. Use mobile sensor and phone utilization data to develop individualized estimates of sociability, activities, and sleep as measured by weekly interviews. Study the predictive value of using data on sociability, activities, and sleep to identify exacerbations of psychiatric symptoms. Methodology: Activities can be assessed with data on movement, location, and habits. Sociability can be assessed with data on communication and public interactions. Sleep can be assessed using data on light, sound, movement, and phone use. Investigators on this project developed a functional mobile app that monitors and transmits mobile sensor and utilization data. Focus groups and in-lab usability testing inform further app and intervention development. Mixed methods research study deployment in Veterans who passively self-track their behaviors and psychiatric symptoms. If this project meets intended goals, the VA will have a mobile analytics platform that continuously monitors behaviors and symptoms of patients with serious mental illness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder, Schizoaffective Disorder, Post-traumatic Stress Disorder
Keywords
Mental health care, Informatics, Predictive Modeling, Bipolar disorder, Psychotic Disorders, Machine learning

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants in the trial are enrolled in an intervention group for 9 months
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mobile application
Arm Type
Experimental
Arm Description
Participants use a mobile application on their smartphone
Intervention Type
Other
Intervention Name(s)
mobile application
Other Intervention Name(s)
VetThrive
Intervention Description
VetThrive is a mobile smartphone application that monitors and transmits mobile sensor and utilization data. This app is deployed in Veteran patients who passively self-track their behaviors and psychiatric symptoms.
Primary Outcome Measure Information:
Title
Feasibility of passive self-tracking of mental health change
Description
Feasibility of passive self-tracking of mental health assessed using qualitative interview data based on the Technology Assessment Model.
Time Frame
3 and 9 months
Title
Estimates of sociability
Description
Use mobile sensor and phone utilization data to develop individualized estimates of sociability.
Time Frame
9 months
Title
Identify exacerbations of psychiatric symptoms
Description
Study the predictive value of using data on sociability, activities, and sleep to identify exacerbations of psychiatric symptoms.
Time Frame
9 months
Title
Acceptability of passive self-tracking of mental health change
Description
Acceptability of passive self-tracking of mental health assessed using qualitative interview data based on the Technology Assessment Model.
Time Frame
3 and 9 months
Title
Safety of passive self-tracking of mental health change
Description
Safety of passive self-tracking of mental health assessed using the occurrence of serious adverse events.
Time Frame
3 and 9 months
Title
Estimates of activities
Description
Use mobile sensor and phone utilization data to develop individualized estimates of activities.
Time Frame
9 months
Title
Estimates of sleep
Description
Use mobile sensor and phone utilization data to develop individualized estimates of sleep.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veteran patient at the Greater Los Angeles Veterans Healthcare Center with a chart diagnosis of serious mental illness, defined as a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder Risk for symptoms based on having had, during the past year, psychiatric hospitalization, psychiatric emergency care, lived at a crisis program, or more than 6 outpatient visits; and, Ownership of a smartphone with a data plan Exclusion Criteria: Under age 18 Has a conservator/legally authorized representative
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander S Young, MD MSHS
Phone
(310) 268-3416
Email
Alexander.Young@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie A Chassman, PhD MSW LCSW-C
Phone
(310) 478-3711
Ext
46614
Email
Stephanie.Chassman@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Stehle Young, MD MSHS
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073-1003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander S Young, MD MSHS
Phone
(310) 268-3416
Email
Alexander.Young@va.gov
First Name & Middle Initial & Last Name & Degree
Stephanie A Chassman, PhD MSW LCSW-C
Phone
(310) 478-3711
Ext
46614
Email
Stephanie.Chassman@va.gov
First Name & Middle Initial & Last Name & Degree
Alexander Stehle Young, MD MSHS
First Name & Middle Initial & Last Name & Degree
Melissa Chinchilla, PhD
First Name & Middle Initial & Last Name & Degree
Shay Cannedy, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35930336
Citation
Young AS, Choi A, Cannedy S, Hoffmann L, Levine L, Liang LJ, Medich M, Oberman R, Olmos-Ochoa TT. Passive Mobile Self-tracking of Mental Health by Veterans With Serious Mental Illness: Protocol for a User-Centered Design and Prospective Cohort Study. JMIR Res Protoc. 2022 Aug 5;11(8):e39010. doi: 10.2196/39010.
Results Reference
result

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Mobile Self-Tracking

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