The SPARC App: A Smartphone Application for the Management of Sarcoidosis-Associated Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of Participants Who Maintain Adherence to at Least Daily Daily Breathing Awareness Meditation Sessions
研究概览
简要总结
Fatigue is a pervasive and disabling symptom in sarcoidosis with limited treatment options. There is a significant association between heightened stress and sarcoidosis-associated fatigue. The proposed project will evaluate the usability/feasibility of a smartphone-based stress management application for the self-management of sarcoidosis-associated stress and fatigue.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sarcoidosis diagnosis based on established criteria
- •≥18 years old
- •able to speak, hear, and understand English
- •elevated SAF (FAS score ≥22)
- •owns smartphone with current data plan
- •willingness and ability to use app to engage in Breathing Awareness Meditation (BAM)
排除标准
- •history of psychotic disorder, bipolar disorder, eating disorder, narcolepsy, cancer diagnosis or treatment in past 12 months
- •positive screening for potential major depression (Patient Health Questionnaire depression scale [PHQ-8; α = .86] score ≥10)
- •untreated sleep apnea (based on home sleep study testing)
- •sarcoidosis exacerbation in past 3 months requiring increase in sarcoidosis medications
- •>2 hr travel distance to medical center (to reduce likelihood of no-show for focus groups)
- •active substance abuse or binge drinking (>21 drinks/week )
结局指标
主要结局
Number of Participants Who Maintain Adherence to at Least Daily Daily Breathing Awareness Meditation Sessions
时间窗: 3 months
Adherence is defined by participants completing 70% of the breathing awareness meditation sessions
Proportion of Participants Recruited
时间窗: 6 months
Recruitment compared to number approached
Number of Participants Who Complete the Study
时间窗: 6 months
Participants complete the study in it's entirety and are able to use the app appropriately
Treatment Satisfaction
时间窗: Month 3
System Usability Scale (SUS) consists of ten statements each with five possible answers ranging from complete rejection to complete agreement. For each statement, the participant gives his or her approval or rejection in the form of a scale ranging from 1=strong approval to 5=strong rejection. The results of the SUS questionnaire are used to calculate a numerical value (SUS score). The results can have a value between 0 (worst application imaginable) and 100 (best application imaginable)
次要结局
- Changes in Stress From Baseline to Month 6(Week 0 and Week 24)
- Changes in Autonomous Motivation(Week 0 and Week 24)
- Changes in Quality of Life(Week 0 and Week 24)
- Change in Sarcoidosis Associated Fatigue From Baseline to Month 6(Week 0 and Week 24)
- Changes in Self-Efficacy From Baseline to Month 3(Week 0 and Week 12)
研究者
W. Ennis James
Assistant Professor
Medical University of South Carolina