Health Outcomes Via Positive Engagement in Schizophrenia (HOPE-S)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical Global Impression scale - Severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Clinical Global Impression scale - Severity
时间窗: 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.
次要结局
- Positive and Negative Syndrome Scale(Week 0, 6, 12, 18, 24)
- Columbia Suicide Severity Rating Scale(Week 0, 6, 12, 18, 24)
- Social and Occupational Functioning Assessment Scale(Week 0, 6, 12, 18, 24)
- Brief Assessment of Cognition in Schizophrenia(Week 0, 24)
- Subjective Well-being under Neuroleptics scale - short form(Week 0, 24)
- Healthcare Utilization(12 months)
- Brief Negative Symptom Scale(Week 0, 24)
- Clinical Global Impression scale - Improvement(Week 6, 12, 18, 24)
- Calgary Depression Scale for Schizophrenia(Week 0, 6, 12, 18, 24)
- Brief Adherence Rating Scale(Week 0, 6, 12, 18, 24)
- 5-level EQ-5D(Week 0, 12, 24)
- Acceptability questionnaire(Week 24 or termination visit)