Clinical trial NCT05023252: Mobile Self-Tracking
Official title: Passive Mobile Self-Tracking of Mental Health by Veterans With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Schizoaffective Disorder
Post-traumatic Stress Disorder
Keywords: Mental health care
Informatics
Predictive Modeling
Bipolar disorder
Psychotic Disorders
Machine learning
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-08-26
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants in the trial are enrolled in an intervention group for 9 months
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

1. Conduct user-centered design of passive mobile self-tracking to support Veterans' management of their mental health.
2. Study the feasibility, acceptability and safety of passive self-tracking of mental health that includes feedback of mental health status to the Veteran.
3. Use mobile sensor and phone utilization data to develop individualized estimates of sociability, activities, and sleep as measured by weekly interviews.
4. 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.

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

Primary outcomes:
measure: Feasibility of passive self-tracking of mental health change
timeFrame: 3 and 9 months
measure: Estimates of sociability
timeFrame: 9 months
measure: Identify exacerbations of psychiatric symptoms
timeFrame: 9 months
measure: Acceptability of passive self-tracking of mental health change
timeFrame: 3 and 9 months
measure: Safety of passive self-tracking of mental health change
timeFrame: 3 and 9 months
measure: Estimates of activities
timeFrame: 9 months
measure: Estimates of sleep
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Alexander Stehle Young, MD MSHS
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Medich M, Cannedy SL, Hoffmann LC, Chinchilla MY, Pila JM, Chassman SA, Calderon RA, Young AS. Clinician and Patient Perspectives on the Use of Passive Mobile Monitoring and Self-Tracking for Patients With Serious Mental Illness: User-Centered Approach. JMIR Hum Factors. 2023 Oct 24;10:e46909. doi: 10.2196/46909.
citation: Lin Z, Weinberger E, Nori-Sarma A, Chinchilla M, Wellenius GA, Jay J. Daily heat and mortality among people experiencing homelessness in 2 urban US counties, 2015-2022. Am J Epidemiol. 2024 Nov 4;193(11):1576-1582. doi: 10.1093/aje/kwae084.