A Stress and Pain Self-management m-Health App for Adult Outpatients with Sickle Cell Disease

项目总结/摘要 我们的长期目标是通过减少阿片类药物的使用来减轻压力并改善镰状细胞病（SCD）的疼痛控制 通过自我管理放松/分散注意力练习（RDE）的干预，名为You科普，We 支持（YCWS）。患有SCD的美国人遭受急性和慢性疼痛的反复发作，这两种疼痛都 会因压力而恶化在我们之前形成性研究的成功基础上，我们现在提出了一个很好的- 设计，适当把握度的研究，以测试YCWS对结局（疼痛强度，压力强度， 阿片类药物使用）成人SCD。我们计划招募170名成年人进行随机对照试验， YCWS对结局（疼痛、压力和阿片类药物使用）的长期（8周）和长期（6个月）影响。 根据最严重的疼痛强度（<=5; >5）分层，我们将患者随机分组： 结果监测+警报/提醒），85例为实验性（结果自我监测+ 警报/提醒+使用YCWS [RDE +支持]）。我们将要求参与者每天报告结果。期间 第1-8周，我们将通过电话、短信或电子邮件向两组发送系统生成的警报/提醒， 促进数据输入（两组）和干预使用支持（实验）。如果患者不进入 24小时后，研究支持人员将联系他/她，以解决数据输入问题（两组）， YCWS使用（实验）。我们将标记时间并跟踪参与者的在线活动，以了解研究 背景，并就工作人员和系统生成的支持的可接受性进行离职面谈。我们将分析 使用混合效应回归模型（短期、长期）解释重复测量的数据 并利用机器学习来构建和评估预测结果的模型。具体目标 目的1：确定YCWS的短期影响。假设：在前8周，与 对照组，实验组将报告疼痛强度的降低（主要结局，0-10量表）， 次要结果-压力强度（0-10级）和阿片类药物使用（口服吗啡当量[OME]）。目标二： 确定YCWS的长期影响。假设：在3-6个月，与对照组相比， 实验组将报告疼痛强度的降低（主要结果，0-10量表）和次要结果， 结果-压力强度（0-10级）和阿片类药物使用（口服吗啡当量[OME]）。目标3 （探索性）：使用机器学习，开发和评估模型，基于 关于他们的组分配和关于他们的个人（例如，自我效能，性别，教育，家庭收入，电脑 经验等）和环境特性（例如，与护理的距离、小区连接的质量等）。 研究结果将指导未来关于实施移动健康的YCWS自我管理的研究 在真实的世界中对成人SCD患者进行干预。研究结果也将指导发现一个理想的交付 YCWS的方法，以及将从YCWS中受益的患者的个人和环境特征 有效控制SCD疼痛及其他类型疼痛及其心理影响。

Project Summary/Abstract Our long-term goal is to reduce stress and improve sickle cell disease (SCD) pain control with less opioid use through an intervention with self-management relaxation/distraction exercises (RDE), named You Cope, We Support (YCWS). Americans living with SCD suffer recurrent episodes of acute and chronic pain, both of which are exacerbated by stress. Building on the successes of our prior formative studies, we now propose a well- designed, appropriately powered study to test efficacy of YCWS on outcomes (pain intensity, stress intensity, opioid use) in adults with SCD. We propose to recruit 170 adults for a randomized controlled trial of the short- term (8 weeks) and long-term (6 months) effects of YCWS on outcomes (pain, stress, and opioid use). Stratified on worst pain intensity (<=5; >5), we will randomly assign patients to groups: 85 to Control (Self- monitoring of outcomes + alerts/reminders), and 85 to Experimental (Self-monitoring of outcomes + alerts/reminders + use of YCWS [RDE + Support]). We will ask participants to report outcomes daily. During weeks 1-8, we will send system-generated alerts/reminders to both groups via phone call, text, or email to facilitate data entry (both groups) and intervention use support (experimental). If the patient does not enter data after 24 hours, study support staff will contact him/her for data entry trouble-shooting (both groups) and YCWS use (experimental). We will time stamp and track participants' online activities to understand the study context and conduct exit interviews on acceptability of the staff and system-generated support. We will analyze data using mixed-effects regression models (short-term, long-term) to account for repeated measurements over time and utilize machine learning to construct and evaluate models predictive of outcomes. Specific aims are: Aim 1: To determine the short-term effects of YCWS. Hypothesis: in the first 8 weeks, compared to the control group, the experimental group will report reductions in pain intensity (primary outcome, 0-10 scale) and secondary outcomes--stress intensity (0-10 scale) and opioid use (oral morphine equivalence [OME]). Aim 2: To determine the long-term effects of YCWS. Hypothesis: in months 3-6, compared to control group, the experimental group will report reductions in pain intensity (primary outcome, 0-10 scale) and secondary outcomes--stress intensity (0-10 scale) and opioid use (oral morphine equivalence [OME]). Aim 3 (exploratory): Using machine learning, to develop and evaluate models that predict patient outcomes based on their group assignment and on their personal (e.g., self-efficacy, sex, education, family income, computer experience, etc.,) and environmental characteristics (e.g., distance from care, quality of cell connection, etc.). Findings will guide future studies on the implementation of the m-Health enabled YCWS self-management intervention in the real world by adults with SCD. Findings also will guide the discovery of an ideal delivery method for YCWS, and personal and environmental characteristics of patients who would benefit from YCWS to control effectively the pain of SCD and other types of pain and its psychological impact.