Clinical trial NCT04230590: Health Outcomes Via Positive Engagement in Schizophrenia
Official title: Health Outcomes Via Positive Engagement in Schizophrenia (HOPE-S)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Schizophrenia Spectrum Disorders
Keywords: Schizophrenia
Digital phenotyping
Relapse
Lead sponsor: Institute of Mental Health, Singapore
Sponsor class: OTHER
Collaborators: name: MOH Office for Healthcare Transformation Pte. Ltd.
First posted: 2020-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants must be diagnosed with schizophrenia spectrum disorders and are within 8 weeks post discharge from hospitalization at the Institute of Mental Health.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Global Impression scale - Severity
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Positive and Negative Syndrome Scale
timeFrame: Week 0, 6, 12, 18, 24
measure: Brief Negative Symptom Scale
timeFrame: Week 0, 24
measure: Calgary Depression Scale for Schizophrenia
timeFrame: Week 0, 6, 12, 18, 24
measure: Clinical Global Impression scale - Improvement
timeFrame: Week 6, 12, 18, 24
measure: Brief Adherence Rating Scale
timeFrame: Week 0, 6, 12, 18, 24
measure: Columbia Suicide Severity Rating Scale
timeFrame: Week 0, 6, 12, 18, 24
measure: Social and Occupational Functioning Assessment Scale
timeFrame: Week 0, 6, 12, 18, 24
measure: Brief Assessment of Cognition in Schizophrenia
timeFrame: Week 0, 24
measure: 5-level EQ-5D
timeFrame: Week 0, 12, 24
measure: Subjective Well-being under Neuroleptics scale - short form
timeFrame: Week 0, 24
measure: Acceptability questionnaire
timeFrame: Week 24 or termination visit
measure: Healthcare Utilization
timeFrame: 12 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Institute of Mental Health
Study officials:
affiliation: Institute of Mental Health, Singapore
name: Jimmy Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdul Rashid NA, Martanto W, Yang Z, Wang X, Heaukulani C, Vouk N, Buddhika T, Wei Y, Verma S, Tang C, Morris RJT, Lee J. Evaluating the utility of digital phenotyping to predict health outcomes in schizophrenia: protocol for the HOPE-S observational study. BMJ Open. 2021 Oct 20;11(10):e046552. doi: 10.1136/bmjopen-2020-046552.