- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04230590
Health Outcomes Via Positive Engagement in Schizophrenia (HOPE-S)
Health Outcomes Via Positive Engagement in Schizophrenia (HOPE-S)
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Zixu Yang
- Phone Number: +65 63893605
- Email: zixu_yang@imh.com.sg
Study Contact Backup
- Name: Nur Amirah Abdul Rashid
- Phone Number: +65 63893630
- Email: nur_amirah_abdul_rashid@imh.com.sg
Study Locations
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Singapore, Singapore, 539747
- Institute of Mental Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
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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
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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.
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up to 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive and Negative Syndrome Scale
Time Frame: Week 0, 6, 12, 18, 24
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A 30-item clinical scale measuring positive symptoms, negative symptoms and general psychopathology.
A higher total score indicates greater symptom severity.
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Week 0, 6, 12, 18, 24
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Brief Negative Symptom Scale
Time Frame: Week 0, 24
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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.
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Week 0, 24
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Calgary Depression Scale for Schizophrenia
Time Frame: Week 0, 6, 12, 18, 24
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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.
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Week 0, 6, 12, 18, 24
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Clinical Global Impression scale - Improvement
Time Frame: Week 6, 12, 18, 24
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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.
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Week 6, 12, 18, 24
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Brief Adherence Rating Scale
Time Frame: Week 0, 6, 12, 18, 24
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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%).
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Week 0, 6, 12, 18, 24
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Columbia Suicide Severity Rating Scale
Time Frame: Week 0, 6, 12, 18, 24
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A scale assessing both suicidal ideation and behaviour.
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Week 0, 6, 12, 18, 24
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Social and Occupational Functioning Assessment Scale
Time Frame: Week 0, 6, 12, 18, 24
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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).
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Week 0, 6, 12, 18, 24
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Brief Assessment of Cognition in Schizophrenia
Time Frame: Week 0, 24
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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.
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Week 0, 24
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5-level EQ-5D
Time Frame: Week 0, 12, 24
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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).
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Week 0, 12, 24
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Subjective Well-being under Neuroleptics scale - short form
Time Frame: Week 0, 24
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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.
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Week 0, 24
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Acceptability questionnaire
Time Frame: Week 24 or termination visit
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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.
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Week 24 or termination visit
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Healthcare Utilization
Time Frame: 12 months
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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.
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12 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jimmy Lee, Institute of Mental Health, Singapore
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/00720
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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