Lupus Intervention for Fatigue Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Change in Fatigue Severity Scale over time
研究概览
简要总结
Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (SLE). The intervention group will receive individual coaching sessions focusing on physical activity and nutrition while the control group will receive individual calls in relation to SLE self-management educational sessions.This study is designed to evaluate the LIFT intervention to decrease fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior (exploratory outcome) in persons with SLE.
详细描述
Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (SLE). The intervention group will receive individual coaching based in motivational interviewing sessions focusing on physical activity and nutrition while the control group will receive individual calls focusing on SLE self-management. This study is designed to evaluate the LIFT intervention to decreased fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior (exploratory outcome) in persons with SLE.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •include meeting at least 4 of 11 American College of Rheumatology (ACR) classification criteria for definite SLE, or 3 out of 11 ACR classification criteria with also meeting at least one SLICC criteria
- •be at least 18 years of age
- •have a BMI between 18-40 kg/m2
- •be able to ambulate at least household distances (50ft)
- •be able to provide informed consent.
- •be able to speak and read English
排除标准
- •include pregnancy at baseline
- •not meeting inclusion criteria.
研究组 & 干预措施
Intervention
The experimental intervention is a unique combination of four individual counseling sessions based in motivational interviewing focusing on physical activity, dietary behavior and behavioral strategies. The individual sessions will provide a tailored personalized intervention including problem-solving and goal setting for increasing physical activity, and following a healthy diet. Healthy Lifestyle Coaches (RN or MPH) will be responsible for conducting the individual for a caseload of participants. There are no drugs involved in the intervention.
干预措施: Experimental (Behavioral)
Control
The control group intervention will receive four individual phone calls checking in with participants regarding questions about the study or from the educational sessions focusing on SLE disease management, each lasting approximately 10-15 minutes.
干预措施: Control (Other)
结局指标
主要结局
Change in Fatigue Severity Scale over time
时间窗: Baseline, 3, 6, 12 months
Online questionnaire
次要结局
- Change in Physical Activity Scale over time(Baseline, 3, 6, 12 months)
- Change in International Physical Activity Questionnaire (IPAQ) over time(Baseline, 3, 6, 12 months)
- Godin Leisure Time Exercise Questionnaire(Baseline, 6, 12 months)
研究者
Rosalind Ramsey-Goldman
Professor
Northwestern University