Design and rationale of a pilot randomized clinical trial investigating the use of a mHealth app for sarcoidosis-associated fatigue.
Design and rationale of a pilot randomized clinical trial investigating the use of a mHealth app for sarcoidosis-associated fatigue.
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DOI：
10.1016/j.conctc.2023.101062
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发表时间：
2023-04
影响因子：
1.5
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中科院分区：
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疲劳是结节病（SP）患者报告最多的症状，是生活质量下降的重要预测因子，与压力和消极情绪状态密切相关。很少有药物用于治疗SP的疲劳，门诊物理康复计划受到可用性和成本的限制。在美国，结节病主要影响少数民族和处于工作年龄的服务不足人群，并且通常资源有限（例如，财务、交通、下班时间），这可能会阻止他们参加面对面的课程。使用移动的保健（mHealth）正在成为提供自我管理资源以改善生活质量的可行替代办法。结节病患者评估和资源伴侣（Sarcoidosis Patient Assessment and Resource Companion，简称SPs）应用程序是一款结节病专用移动健康应用程序，旨在改善SP的疲劳和压力。它促使SP进行呼吸意识冥想（BAM），并包含旨在提高自我效能的教育模块。在本文中，我们描述了一项为期3个月的随机对照试验的设计和方法，该试验在50名患有严重疲劳的SP（FAS ≥22）中比较了使用TweenApp（每天两次，每次10分钟BAM）与标准治疗。Fitbit®手表将在BAM会话后提供即时心率反馈，以客观地监测依从性。主要结果是可扩展应用程序的可行性和可用性（每月收集）。次要终点包括改善疲劳、压力和生活质量的初步疗效。我们预计，智能手机应用程序将成为一种可用且可行的干预措施，有可能克服更传统的面对面程序的障碍。
Fatigue is the most reported symptom in patients with sarcoidosis (SPs) and is a significant predictor of decreased quality of life that is strongly associated with stress and negative mood states. Few medications exist for treating fatigue in SPs, and outpatient physical rehabilitation programs are limited by availability and cost. Sarcoidosis in the US predominantly impacts minorities and underserved populations who are of working age and often have limited resources (e.g., financial, transportation, time off work) that may prevent them from attending in-person programs. The use of mobile health (mHealth) is emerging as a viable alternative to provide access to self-management resources to improve quality of life. The Sarcoidosis Patient Assessment and Resource Companion (SPARC) App is a sarcoidosis-specific mHealth App intended to improve fatigue and stress in SPs. It prompts SPs to conduct breathing awareness meditation (BAM) and contains educational modules aimed at improving self-efficacy. Herein we describe the design and methods of a 3-month randomized control trial comparing use of the SPARC App (10-min BAM twice daily) to standard care in 50 SPs with significant fatigue (FAS ≥22). A Fitbit® watch will provide immediate heartrate feedback after BAM sessions to objectively monitor adherence. The primary outcomes are feasibility and usability of the SPARC App (collected monthly). Secondary endpoints include preliminary efficacy at improving fatigue, stress, and quality of life. We expect the SPARC App to be a useable and feasible intervention that has potential to overcome barriers of more traditional in-person programs.