Schizophrenia Spectrum DisordersHOPE-SNCT04230590
Health Outcomes Via Positive Engagement in Schizophrenia
An observational study of Schizophrenia Spectrum Disorders, run by Institute of Mental Health, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Schizophrenia Spectrum Disorders
- What is being tested?
- Observational
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 4 Nov 2019to Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia Spectrum Disorders
- Being tested
- Observational
- Keywords
- Schizophrenia, Digital phenotyping, Relapse
- Medical subject headings
- Schizophrenia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with schizophrenia spectrum disorders | Within 8 weeks post discharge from hospitalization at the Institute of Mental Health Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 weeks
Secondary outcomes (12)
Positive and Negative Syndrome Scale
A 30-item clinical scale measuring positive symptoms, negative symptoms and general psychopathology. A higher total score indicates greater symptom severity.
Measured: Week 0, 6, 12, 18, 24
Brief Negative Symptom Scale
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.
Measured: Week 0, 24
Calgary Depression Scale for Schizophrenia
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.
Measured: Week 0, 6, 12, 18, 24
Clinical Global Impression scale - Improvement
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.
Measured: Week 6, 12, 18, 24
Brief Adherence Rating Scale
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%).
Measured: Week 0, 6, 12, 18, 24
Columbia Suicide Severity Rating Scale
A scale assessing both suicidal ideation and behaviour.
Measured: Week 0, 6, 12, 18, 24
Social and Occupational Functioning Assessment Scale
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).
Measured: Week 0, 6, 12, 18, 24
Brief Assessment of Cognition in Schizophrenia
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.
Measured: Week 0, 24
5-level EQ-5D
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).
Measured: Week 0, 12, 24
Subjective Well-being under Neuroleptics scale - short form
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.
Measured: Week 0, 24
Acceptability questionnaire
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.
Measured: Week 24 or termination visit
Healthcare Utilization
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start4 Nov 2019
- Primary completion27 Jun 2023
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Mental Health, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Responsible party
- Sponsor
- Investigators
- Jimmy Lee, Principal investigator, Institute of Mental Health, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230590
- Sponsor's protocol ID
- 2019/00720
- Other IDs
- 2019
- Acronym
- HOPE-S
- Status last verified
- Sep 2023
- First submitted
- 30 Dec 2019
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34670760
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Outcomes Via Positive Engagement in Schizophrenia (HOPE-S)
- ClinicalTrials.gov ID
- NCT04230590
- Acronym / sponsor ID
- HOPE-S / 2019/00720
- Conditions
- Schizophrenia Spectrum Disorders
- Keywords
- Schizophrenia, Digital phenotyping, Relapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Mental Health, SingaporeUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- Feb 2024 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with schizophrenia spectrum disorders | – | Other: ObservationalWithin 8 weeks post discharge from hospitalization at the Institute of Mental Health |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalParticipants 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. | Other | Participants with schizophrenia spectrum disorders |
Primary outcome
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.
12 secondary outcomes
Positive and Negative Syndrome Scale
Time frame: Week 0, 6, 12, 18, 24
Brief Negative Symptom Scale
Time frame: Week 0, 24
Calgary Depression Scale for Schizophrenia
Time frame: Week 0, 6, 12, 18, 24
Clinical Global Impression scale - Improvement
Time frame: Week 6, 12, 18, 24
Brief Adherence Rating Scale
Time frame: Week 0, 6, 12, 18, 24
Columbia Suicide Severity Rating Scale
Time frame: Week 0, 6, 12, 18, 24
Social and Occupational Functioning Assessment Scale
Time frame: Week 0, 6, 12, 18, 24
Brief Assessment of Cognition in Schizophrenia
Time frame: Week 0, 24
5-level EQ-5D
Time frame: Week 0, 12, 24
Subjective Well-being under Neuroleptics scale - short form
Time frame: Week 0, 24
Acceptability questionnaire
Time frame: Week 24 or termination visit
Healthcare Utilization
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Derived from this study: PubMed 34670760Abdul 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jimmy Lee principal investigator
Institute of Mental Health, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia Spectrum Disorders, run by Institute of Mental Health, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression scale - Severity (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04230590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.