Health Outcomes Via Positive Engagement in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-04

Study Completion Date

2024-02-29

Brief Summary

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This is an observational study where digital, clinical and health utilization data are collected from individuals with schizophrenia spectrum disorders who have been recently discharged from a psychiatric hospitalization. The data will be used towards building a model/algorithm capable of monitoring mental health and predicting adverse clinical events, such as relapse and re-admissions.

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Detailed Description

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In this research, participants will attend 6-weekly follow-up research visits (Weeks 0, 6, 12, 18, 24) over 24 weeks where clinical symptoms, cognition, functioning and well-being will be assessed. Passive digital data from smartphones and wrist wearable devices (e.g. sleep patterns, heart rate, location variance and entropy, phone usage frequency and duration, finger taps, ambient light, and physical activity) will be collected continuously during the 24 weeks. Audio recorded follow-up phone calls will be made to participants who consented to the optional audio recorded component at Weeks 3, 9, 15, 21. This study will also carry out an administrative follow-up at Week 24/termination and Week 52 to obtain healthcare utilization information (e.g. scheduled or unscheduled appointments, readmission, etc) since study enrollment.

Study findings will shed light on the relationship between digital biomarkers with clinical status and health utilization outcomes, as well as explore the feasibility and acceptability of digital sensors.

Conditions

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Schizophrenia Spectrum Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with schizophrenia spectrum disorders

Within 8 weeks post discharge from hospitalization at the Institute of Mental Health

Observational

Intervention Type OTHER

Participants will not receive any study intervention.

During the 24-week study period, participants will complete five assessment visits and passive digital data from participant's smartphone and study-provided wrist wearable device will be collected.

Interventions

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Observational

Participants will not receive any study intervention.

During the 24-week study period, participants will complete five assessment visits and passive digital data from participant's smartphone and study-provided wrist wearable device will be collected.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult male or female aged 21 to 65 years (inclusive) at time of informed consent
* Has capacity to give informed consent
* Able to understand and comply with instructions in English
* Diagnosis of schizophrenia spectrum disorders assessed using the Structured Clinical Interview for DSM Disorders (SCID)
* Discharged patients from IMH (within 8 weeks post-discharge from IMH)

Exclusion Criteria

* Female who is currently pregnant or planning a pregnancy within 6 months
* Has any other clinically significant medical condition or circumstance that, in the opinion of the Investigator, could affect participant safety, preclude evaluation of response, interfere with the ability to comply with study procedures, or prohibit completion of the study
* Has visual or physical motor impairment that could interfere with study tasks

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No