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

SPARC 应用程序：用于管理结节病相关疲劳的智能手机应用程序

基本信息

批准号：
10250998
负责人：
Walter Ennis James
金额：
$ 18.81万
依托单位：
MEDICAL UNIVERSITY OF SOUTH CAROLINA
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-01 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10250998
关键词：
Address Adherence Affect African American American Anxiety Awareness Back Behavioral Benchmarking Breathing Cellular Phone Chronic Disease Chronic Obstructive Airway Disease Clinical Clip Cognitive Companions Control Groups Data Development Disease Europe Evaluation Exercise Fatigue Feedback Focus Groups Frequencies Granulomatous HIV Health Personnel Health Promotion Health Technology Healthcare Heart Rate Inflammatory Instruction Interview Knowledge Learning Module Link Malignant Neoplasms Measures Medical Meditation Mental Depression Mental Health Methodological Studies Mobile Health Application Motivation Outcome Ownership Patients Pharmacology Photoplethysmography Physiological Population Poverty Prevention program Provider Psychological reinforcement Quality of life Questionnaires Race Randomized Randomized Controlled Trials Reaction Regimen Relaxation Reporting Research Resources Sampling Sarcoidosis Secondary Prevention Self Determination Self Efficacy Self Management Services Stress Structure Summary Reports Surveys Symptoms Techniques Telephone Testing Text Messaging Time United States Work arm attentional control base behavioral adherence coping cost disabling symptom exercise rehabilitation experience follow-up health care availability health care disparity health disparity improved iterative design literacy mHealth negative affect perceived stress physical conditioning preference primary outcome program dissemination programs racial and ethnic rate of change recruit response retention rate satisfaction secondary outcome self-management program service providers smartphone Application standard care stress management theories tool treatment effect uptake usability walking program

项目摘要

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.

结节病是一种全身性肉芽肿性炎症性疾病，在美国的美国人。80%的结节病患者报告结节病相关性疲乏（SAF）患者（SP），并被认为是最重要的预测生活质量（QoL），由于其负面影响身体和心理健康。SP经历显著的压力，这与以下因素有很强的关联：疲劳增加和生活质量降低。基于移动的健康技术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并改善其他慢性疾病的生活质量。除了我们的概念验证试验外，对照试验（RCT）评估理论驱动，量身定制的mHealth应用程序解决SAF。响应于 PA-18-389，拟议的R21将完善和测试结节病患者评估和资源伴侣（Companion）应用程序。伴侣包括多层次的组件：1）即时生理反馈， BAM会话期间的心率变化，2）通过心率时间戳的BAM依从性的客观指标数据，3）量身定制的短信传递动机反馈和自我决定指导的强化理论和基于对每日BAM会话的坚持，4）医疗保健提供商和技术服务电话访问链接和5）向供应商提供自动摘要报告。其目标如下：目标1：开发和完善客户服务应用程序，以帮助SP通过进一步使用BAM应对压力和SAF 使用焦点小组和基于可用性的优化后实验室调整Tension Tamer应用程序（HL 114957）评价。目的2：在50名SAF SP中开展一项为期12周的2组（双盲与加强标准治疗）可行性RCT。评估将在基线、第4周和第12周进行，并在第24周进行试验后随访。 2a：可行性基准的主要结果：招募率≥ 80%，保留率≥ 80%和可用性; ≥.70 坚持每天两次BAM会议; ≥ 75%的样本在可用性和满意度方面得分高于平均水平问卷调查（SUS >68，uMARS >64和TSUQ >60）。 2b：SAF、自我效能、压力、自主动机和QoL变化的次要结局。目标3：在试验结束后，与提供者和工作人员（n=6-8）以及随机样本进行焦点小组讨论的用户（n=12），以评估关键用户反应，包括感知的可接受性、可用性、显著性和确定可持续性促进因素/障碍。对AIMS 2和3的数据进行三角测量，以进一步完善和优化准备一项全面的疗效RCT。长期目标是为SAF制定实用、有效和可持续的移动健康计划。该应用程序的推广将有助于减轻SAF的负担，减少医疗保健差距，改善SP的生活质量。