On Track for Wellness: Stepped-wedge Cluster Randomized Trial of a Fitbit Enhanced Health Intervention for Early Onset Psychosis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 365
- 主要终点
- Increase physical exercise
研究概览
简要总结
This study will evaluate a program called On Track for Wellness (OTW) which is being adopted by the Illinois Department of Human Services' Division of Behavioral Health & Recovery (DBHR) for use in all state-funded early psychosis programs in Illinois. OTW combines use of Fitbit activity trackers with health education, goal setting to promote health activation, and ongoing support for maintaining healthy lifestyles. Successful completion of this research will gauge the effectiveness of this program in improving sleep hygiene and increasing physical activity among people recently diagnosed with schizophrenia or other psychotic disorders.
详细描述
The study involves 2 phases. The first phase involves a pilot test conducted in two of the state's 18 early psychosis programs, in which interview data will be gathered from 2 staff and 5 clients at each program (total N=4 staff and 10 clients). The second phase involves training all remaining programs to deliver OTW and using state administrative data as well as data from clients' Fitbit accounts to evaluate changes in client outcomes over the three-year study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •client at First Episode psychosis program -
排除标准
- •not a client at a First Episode psychosis program
研究组 & 干预措施
Services as Usual
Services as usual
OTW intervention
OTW intervention
干预措施: On Track for Wellness (Other)
结局指标
主要结局
Increase physical exercise
时间窗: Day 1
increase in # of steps per day
次要结局
未报告次要终点