跳至主要内容
临床试验/NCT05023252
NCT05023252已完成不适用

Passive Mobile Self-Tracking of Mental Health by Veterans With Serious Mental Illness

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2021年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
2
主要终点
Feasibility of Passive Self-tracking of Mental Health

研究概览

简要总结

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 smartphone. 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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Feasibility of Passive Self-tracking of Mental Health

时间窗: 9 months

Feasibility of passive self-tracking of mental health. The number of participants who completed the study.

Estimates of Sociability

时间窗: 9 months

Use mobile sensor and phone utilization data to develop individualized estimates of sociability. There was an effort to calculate an estimate of sociability for each participant. Some participants had insufficient data collected to calculate an estimate. The intent is to determine the number of participants for whom this outcome can be estimated. The investigators report here on the number of participants for whom an estimate of sociability could be successfully calculated.

Identify Exacerbations of Psychiatric Symptoms

时间窗: 9 months

Study the predictive value of using data on sociability, activities, and sleep to identify exacerbations of psychiatric symptoms. There was an effort to calculate identify exacerbations of psychiatric symptoms for each participant. Some participants had insufficient data collected to identify exacerbations. The intent is to determine the number of participants for whom this outcome can be estimated. The investigators report here on the number of participants for whom exacerbations of psychiatric symptoms could be successfully calculated.

Acceptability of Passive Self-tracking of Mental Health

时间窗: 9 months

Acceptability of passive self-tracking of mental health. The number of participants who completed the study.

Safety of Passive Self-tracking of Mental Health

时间窗: 9 months

Safety of passive self-tracking of mental health. The number of participants with a serious adverse event.

Estimates of Activities

时间窗: 9 months

Use mobile sensor and phone utilization data to develop individualized estimates of activities. There was an effort to calculate an estimate of activity for each participant. Some participants had insufficient data collected to calculate an estimate. The intent is to determine the number of participants for whom this outcome can be estimated. The investigators report on the number of participants for whom an estimate of activity could be successfully calculated.

Estimates of Sleep

时间窗: 9 months

Use mobile sensor and phone utilization data to develop individualized estimates of sleep. There was an effort to calculate an estimate of sleep for each participant. Some participants had insufficient data collected to calculate an estimate. The intent is to determine the number of participants for whom this outcome can be estimated. The investigators report here on the number of participants for whom an estimate of sleep could be successfully calculated.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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