A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Relapses in Participants
研究概览
简要总结
This study was a 2-arm randomized control trial (RCT) designed to test a multi-modal smartphone data collection system that provided mobile monitoring of schizophrenia to detect early signs of relapse. The RCT compared an arm with participants who received treatment as usual with an arm that received the smartphone system for a year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded clinical assessors also conducted assessments with all participants at baseline and every 3 months post-randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for schizophrenia, schizoaffective disorder, or psychosis not otherwise specified based on a chart diagnosis
- •18 years or older
- •An inpatient psychiatric hospitalization, daytime psychiatric hospitalization, outpatient crisis management, or short-term psychiatric hospital emergency room within 12 months before study entry
- •Willing and able to provide informed consent
排除标准
- •Hearing, vision, or motor impairment that make it impossible to operate a smartphone (determined using a demonstration smartphone for screening)
- •6th grade reading level (determined by Wide Range Achievement Test- 4th Edition)
研究组 & 干预措施
Device: Smartphone
Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.
干预措施: Device: Smartphone (Behavioral)
Treatment as Usual
Treatment as usual included outpatient case management, linkage to services and medication monitoring.
干预措施: Treatment as usual (Behavioral)
结局指标
主要结局
Relapses in Participants
时间窗: 1 year
A count of participants who experienced relapse, as defined as one of the following events: psychiatric hospitalization, a significant increase in the level of psychiatric care (i.e. frequency and intensity of services), an increase in medication in addition to a 25% increase in Brief Psychiatric Rating Scale (BPRS) from last assessment, suicidal or homicidal ideation that was clinically significant in the investigator's judgement, deliberate self-injury, violent behavior resulting in damage to another person or property.
Time to Relapse
时间窗: From randomization date until first relapse (evaluated approximately every 3 months until their last study visit which occurred approximately 12 months from randomization for those who completed the study).
Time to first relapse was defined as the time from randomization until the first relapse. Participants who did not experience a relapse were censored at their last known time relapse-free. Time-to-first relapse was estimated using the Kaplan-Meier method.
次要结局
- Depression(Assessed at baseline and every three months for one year.)
- Social Functioning(Assessed at baseline and every three months for one year.)
- Psychotic Symptom Severity(Assessed at baseline and every three months for one year.)