The SPARC App: A Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

结节病是一种全身性肉芽肿性炎症性疾病，对非洲人的影响不成比例。 在美国的美国人。结节病相关性疲劳(SAF)占结节病的80%。 患者(SP)，由于其负面影响，被认为是最重要的生活质量(QOL)预测因子 关于身心健康的问题。SP承受着巨大的压力，这与 疲劳感增加，生活质量降低。基于移动健康技术(MHealth)的压力管理 包括呼吸意识冥想(BAM)在内的技术已被证明可以减轻压力和疲劳。 改善其他慢性病患者的生活质量。除了我们的概念验证试验之外，还没有随机的 对照试验(RCT)评估理论驱动的、针对SAF的量身定制的mHealth应用程序。作为对.的回应 PA-18-389，拟议的R21将完善和测试结节病患者评估和资源 同伴(SPARC)应用程序。SPARC包括多个层次的组件：1)即时生理反馈 心率在BAM治疗期间的变化，2)通过心率时间戳客观地指示BAM的依从性 数据，3)定制的文本消息提供由自决引导的激励性反馈和强化 理论并基于坚持每天的BAM会议，4)医疗保健提供商和技术服务电话接入 链接和5)到供应商的自动摘要报告。目标如下： 目标1：开发和改进SPARC应用程序，以帮助SP应对压力和SAF使用BAM通过进一步 使用焦点小组和基于可用性的后期改进实验室对TRANSIAN Tamer APP(HL114957)进行调整 评估。 目标2：在50个有SAF的SP中进行12周的2臂(SPARC与增强型标准护理)可行性随机对照试验。 评估将在基线、第4周和第12周进行，试验后后续将在第24周进行。 2A：可行性基准的主要结果：≥80%的招聘，≥80%的保留率和可用性；≥.70 坚持每天两次的≥会议；75%的样本在易用性和满意度方面的得分高于平均水平 问卷(SUS&GT；68；UMARS&GT；&TSUQ&GT；60)。 2B：SAF、自我效能、压力、自主动机和生活质量变化的次要结果。 目标3：在SPARC试验后与提供者和工作人员(n=6-8)进行随机抽样的焦点小组 SPARC用户(n=12)评估关键用户反应，包括感知的可接受性、可用性、显著程度和 确定可持续发展的促进者/障碍。对AIMS 2和AIMS 3中的数据进行三角测量，以进一步细化和优化 SPARC，并为全面的疗效RCT做准备。 长期目标是为SAF制定实用、有效和可持续的mHealth计划。 SPARC App的推广将有助于减轻SAF的负担，减少医疗差距，以及 提高服务提供商的服务质量。

Sarcoidosis is a systemic granulomatous inflammatory disease that disproportionately affects African Americans in the United States. Sarcoidosis associated fatigue (SAF) is reported by 80% of sarcoidosis patients (SPs) and is considered the most important predictor of quality of life (QoL) due to its negative effects on physical and psychological health. SPs experience significant stress, which has a strong association with increased fatigue and low quality of life. Mobile health technology-based (mHealth) stress management techniques including breathing awareness meditation (BAM) have been shown to reduce stress and fatigue and improve QoL in other chronic diseases. Besides our proof of concept trial, there have been no randomized controlled trials (RCTs) evaluating theory driven, tailored mHealth applications addressing SAF. In response to PA-18-389, the proposed R21will refine and test the Sarcoidosis Patient Assessment and Resource Companion (SPARC) app. SPARC includes multi-level components: 1) immediate physiological feedback of heart rate changes during BAM sessions, 2) objective indicator of BAM adherence via timestamp of heart rate data ,3) tailored text message delivered motivational feedback and reinforcement guided by self-determination theory and based upon adherence to daily BAM sessions, 4) healthcare provider & tech service phone access links and 5) automated summary reports to providers. The aims are as follows: Aim 1: Develop and refine the SPARC App to assist SPs in coping with stress & SAF using BAM via further adaptation of Tension Tamer app (HL114957) using focus groups and post refinement lab based usability evaluations. Aim 2: Conduct a 12 week, 2-arm (SPARC vs. enhanced Standard Care) feasibility RCT in 50 SPs with SAF. Evaluations will occur at baseline, weeks 4 &12 and a post-trial follow-up at week 24. 2a: Primary outcomes of feasibility benchmarks: ≥ 80% recruitment, ≥80 % retention rates & usability; ≥.70 adherence to twice daily BAM sessions; ≥ 75 % of sample will score above average on usability & satisfaction questionnaires (SUS >68, uMARS >64& TSUQ >60). 2b: Secondary outcomes of changes in SAF, self-efficacy, stress, autonomous motivation, and QoL. Aim 3: Conduct focus groups after the SPARC trial with providers and staff (n=6-8) and with a random sample of SPARC users (n=12) to assess key user reactions including perceived acceptability, usability, salience, and identify sustainability facilitators/barriers. Triangulate data from AIMS 2 & 3 to further refine and optimize SPARC and prepare for a full-scale efficacy RCT. Long-term objective is to develop practical, effective and sustainable mHealth program for SAF. Dissemination of the SPARC App will help ameliorate the burden of SAF, decrease healthcare disparities, and improve QoL in SPs.