Chandler Jessica, Christon Lillian M, Benfield Katie, Pairet Samantha, Hoffman Maria, Treiber Frank, Mueller Martina, James W Ennis
MUSC, College of Nursing, Department of Nursing, Technology Applications Center for Healthful Lifestyles, United States.
Medical University of South Carolina (MUSC), College of Medicine, Department of Psychiatry & Behavioral Sciences, United States.
Contemp Clin Trials Commun. 2023 Jan 16;32:101062. doi: 10.1016/j.conctc.2023.101062. eCollection 2023 Apr.
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.
疲劳是结节病患者中最常报告的症状，是生活质量下降的重要预测指标，与压力和负面情绪状态密切相关。治疗结节病患者疲劳的药物很少，门诊物理康复项目受到可用性和成本的限制。美国的结节病主要影响少数族裔和服务不足的人群，这些人群处于工作年龄，往往资源有限（如经济、交通、工作时间），这可能会阻碍他们参加面对面的项目。移动健康（mHealth）的使用正在成为一种可行的替代方案，以提供自我管理资源来改善生活质量。结节病患者评估和资源伴侣（SPARC）应用程序是一款针对结节病的移动健康应用程序，旨在改善结节病患者的疲劳和压力。它促使结节病患者进行呼吸意识冥想（BAM），并包含旨在提高自我效能感的教育模块。在此，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，该试验比较了SPARC应用程序（每天两次10分钟的BAM）与50名有明显疲劳（疲劳评估量表≥22）的结节病患者的标准护理。Fitbit®手表将在BAM课程后提供即时心率反馈，以客观监测依从性。主要结果是SPARC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SPARC应用程序将是一种可用且可行的干预措施，有可能克服更传统的面对面项目的障碍。
