Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04230590
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
MOH Office for Healthcare Transformation, Singapore
Information provided by (Responsible Party):
Institute of Mental Health, Singapore

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.

Condition or disease Intervention/treatment
Schizophrenia Spectrum Disorders Other: Observational

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Health Outcomes Via Positive Engagement in Schizophrenia (HOPE-S)
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


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

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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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%).

  6. Columbia Suicide Severity Rating Scale [ Time Frame: Week 0, 6, 12, 18, 24 ]
    A scale assessing both suicidal ideation and behaviour.

  7. 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).

  8. 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.

  9. 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).

  10. 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.

  11. 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.

  12. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230590


Contacts
Layout table for location contacts
Contact: Zixu Yang +65 63893605 zixu_yang@imh.com.sg
Contact: Nur Amirah Abdul Rashid +65 63893630 nur_amirah_abdul_rashid@imh.com.sg

Locations
Layout table for location information
Singapore
Institute of Mental Health Recruiting
Singapore, Singapore, 539747
Contact: Zixu Yang    +65 63893605    zixu_yang@imh.com.sg   
Contact: Nur Amirah Abdul Rashid    +65 63893630    nur_amirah_abdul_rashid@imh.com.sg   
Sponsors and Collaborators
Institute of Mental Health, Singapore
MOH Office for Healthcare Transformation, Singapore
Investigators
Layout table for investigator information
Principal Investigator: Jimmy Lee Institute of Mental Health, Singapore
Layout table for additonal information
Responsible Party: Institute of Mental Health, Singapore
ClinicalTrials.gov Identifier: NCT04230590    
Other Study ID Numbers: 2019/00720
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Mental Health, Singapore:
Schizophrenia
Digital phenotyping
Relapse
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders