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

September 27, 2023 updated by: Institute of Mental Health, Singapore

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

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Singapore, Singapore, 539747
        • Institute of Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with schizophrenia spectrum disorders
Within 8 weeks post discharge from hospitalization at the Institute of Mental Health

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression scale - Severity
Time Frame: up to 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Syndrome Scale
Time Frame: Week 0, 6, 12, 18, 24
A 30-item clinical scale measuring positive symptoms, negative symptoms and general psychopathology. A higher total score indicates greater symptom severity.
Week 0, 6, 12, 18, 24
Brief Negative Symptom Scale
Time Frame: Week 0, 24
A 13-item scale that measures five negative symptom domains (blunted affect, alogia, asociality, anhedonia and avolition) and a subscale on Lack of Normal distress. Higher total score indicates greater negative symptoms.
Week 0, 24
Calgary Depression Scale for Schizophrenia
Time Frame: Week 0, 6, 12, 18, 24
CDSS is a scale designed for the assessment of depression in schizophrenia, which differentiates between depression and the negative and positive symptoms of schizophrenia. Higher total score reflects greater severity.
Week 0, 6, 12, 18, 24
Clinical Global Impression scale - Improvement
Time Frame: Week 6, 12, 18, 24
A single item which measures how much the patient's illness has improved or worsened relative to a baseline state on a 7-point scale. A higher rating indicates greater worsening of illness.
Week 6, 12, 18, 24
Brief Adherence Rating Scale
Time Frame: Week 0, 6, 12, 18, 24
A clinician-administered instrument to assess oral antipsychotic medication adherence of outpatients with schizophrenia. Greater proportion of doses taken in the past month indicate greater adherence (range: 0%-100%).
Week 0, 6, 12, 18, 24
Columbia Suicide Severity Rating Scale
Time Frame: Week 0, 6, 12, 18, 24
A scale assessing both suicidal ideation and behaviour.
Week 0, 6, 12, 18, 24
Social and Occupational Functioning Assessment Scale
Time Frame: Week 0, 6, 12, 18, 24
A scale designed to evaluate an individual's level of social and occupational functioning; its rating is not directly influenced by the overall severity of the individual's psychological symptoms. A greater rating reflects superior functioning in various areas of life (range: 0-100).
Week 0, 6, 12, 18, 24
Brief Assessment of Cognition in Schizophrenia
Time Frame: Week 0, 24
A cognitive battery which assesses attention, verbal and working memory, motor and processing speed, verbal fluency, reasoning and problem solving. Higher composite score indicates better cognitive function.
Week 0, 24
5-level EQ-5D
Time Frame: Week 0, 12, 24
A standardized instrument developed as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. A higher score indicates best health imagined (range: 0-100).
Week 0, 12, 24
Subjective Well-being under Neuroleptics scale - short form
Time Frame: Week 0, 24
A self-rated instrument to assess well-being from a patient's perspective based on their subjective experiences during antipsychotic treatment. Higher total score indicates greater well-being.
Week 0, 24
Acceptability questionnaire
Time Frame: Week 24 or termination visit
This questionnaire consists of an item measuring participants' satisfaction based on their experience of using digital devices on a scale range of 1 (Strongly disagree) to 7 (Strongly agree). Two other qualitative items in this questionnaire gather feedback on the strengths and suggested improvements for the system and user satisfaction.
Week 24 or termination visit
Healthcare Utilization
Time Frame: 12 months
Data from IMH's medical records which document events such as scheduled appointments, defaults, E-room attendances and hospitalizations will be used to explore healthcare utilization and its relationship with digital biomarkers.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jimmy Lee, Institute of Mental Health, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2019

Primary Completion (Actual)

June 27, 2023

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

December 30, 2019

First Submitted That Met QC Criteria

January 13, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2019/00720

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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