Health Outcomes Via Positive Engagement in Schizophrenia

NCT04230590 | Unknown DMC

• 1 other identifier: 2019/00720
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia Spectrum Disorders

Keywords

Schizophrenia; Digital phenotyping; Relapse

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression scale - Severity

  A single item measuring severity of illness at the point of assessment relative to a clinician's experience with patients of the same diagnosis on a 7-point scale; a higher rating indicates greater severity.

  up to 24 weeks

Secondary Outcomes (12)

• Positive and Negative Syndrome Scale

  Week 0, 6, 12, 18, 24

• Brief Negative Symptom Scale

  Week 0, 24

• Calgary Depression Scale for Schizophrenia

  Week 0, 6, 12, 18, 24

• Clinical Global Impression scale - Improvement

  Week 6, 12, 18, 24

• Brief Adherence Rating Scale

  Week 0, 6, 12, 18, 24

Study Arms (1)

Participants with schizophrenia spectrum disorders

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

Other: Observational

Interventions

Observational 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.

Participants with schizophrenia spectrum disorders

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Mental Health, Singapore: lead
• MOH Office for Healthcare Transformation Pte. Ltd.: collaborator

Study Sites (1)

Institute of Mental Health

Singapore, 539747, Singapore

Location

Related Publications (1)

• 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.

  PMID: 34670760 DERIVED

MeSH Terms

Conditions

Schizophrenia; Recurrence

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Jimmy Lee

  Institute of Mental Health, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 18, 2020
• Study Start: November 4, 2019
• Primary Completion: June 27, 2023
• Study Completion: February 1, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

SG (1)