Health Outcomes Via Positive Engagement in Schizophrenia (HOPE-S)

Institute of Mental Health, Singapore

Status

Active, not recruiting

Conditions

Schizophrenia Spectrum Disorders

Treatments

Other: Observational

Study type

Observational

Funder types

Other

Identifiers

NCT04230590

2019/00720

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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