Brain Boost Program to Improve Cognitive Function in People With Systemic Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in objective cognitive function from baseline to week 8
研究概览
简要总结
The purpose of this study is to examine whether an 8-week online educational group-based program tailored to people with systemic sclerosis can help improve cognitive function and well-being.
The study team hypothesize that participants that receive the intervention will have better improvements immediately after treatment at week 8 in all cognitive function measures, non-cognitive symptoms, and self-management compared to those in the waitlist control.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have physician-diagnosis of Systemic sclerosis (SSc) (any subtype)
- •A score of ≥ 10 on the Perceived Deficits Questionnaire
- •A score of ≤ 7 on the 6-Item Cognitive Impairment Test
- •Have access to a reliable, internet-connected device (e.g. computer, smartphone, tablet)
- •Visual acuity with correction sufficient to work on a computer, smartphone, tablet or screen
- •Be able to read, speak, and understand English
排除标准
- •Diagnosis of dementia or head injury
- •Other neurological disorders that might impact cognition
- •Have major psychiatric disorder such as major depression and schizophrenia
- •Complex, unstable health issues that would preclude full participation in the study (like a planned surgery or active cancer treatment)
研究组 & 干预措施
Brain Boost group
干预措施: Brain Boost group (Behavioral)
Waitlist group
干预措施: Waitlist group (Other)
结局指标
主要结局
Change in objective cognitive function from baseline to week 8
时间窗: Baseline, 8 weeks
This will be assessed using the online platform BrainCheck. The following tests will be included: (1) Trail Making A \& B (attention and mental flexibility); (2) Stroop Color and Word test (executive function); (3) Digit-Symbol Substitution (processing speed); and (4) Immediate and Delayed Recognition tests (memory). A composite score will be calculated through BrainCheck to assess global cognitive function. The score range is 0-200 a higher score means greater cognitive function.
次要结局
- Change in perceived cognitive function will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) cognitive function ability 4a short form(Baseline, 8 weeks)
- Change in pain will be measured using the PROMIS pain interference short form(Baseline, 8 weeks)
- Change in depressed mood will be measured using the PROMIS depression short form(Baseline, 8 weeks)
- Change in fatigue will be measured using the PROMIS fatigue short form(Baseline, 8 weeks)
- Change in self-management will be evaluated using the Patient Activation Measure (PAM)(Baseline, 8 weeks)
研究者
Yen T Chen, PhD
Research Assistant Professor
University of Michigan