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

适用于镰状细胞病成人门诊患者的压力和疼痛自我管理移动健康应用程序

• 批准号: 10416042
• 负责人: Miriam Omelebele Ezenwa
• 金额: $ 52.11万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-07 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10416042
• 关键词: Absenteeism; Acute; Acute Pain; Adult; American; Behavior Therapy; Caring; Cells; Characteristics; Chronic Disease; Clip; Cognitive Therapy; Computers; Control Groups; Custom; Data; Dose; Education; Electronic Mail; Exercise; Family; Future; Goals; Health; Health Care Costs; Healthcare; Heterogeneity; Hour; Image; Income; Individual; Intervention; Intervention Studies; Interview; Life; Long-Term Effects; Machine Learning; Measurement; Methods; Mobile Health Application; Modeling; Monitor; Names; Nature; Opioid; Opioid Analgesics; Oral; Outcome; Outpatients; Pain; Pain intensity; Pain management; Participant; Patient Recruitments; Patient-Focused Outcomes; Patients; Protocols documentation; Psychological Impact; Randomized; Randomized Controlled Trials; Recurrence; Relaxation; Reporting; Research; Research Personnel; Schools; Self Efficacy; Self Management; Sickle Cell Anemia; Stress; Suggestion; Support System; System; Telephone; Testing; Text; Therapeutic Intervention; Time; Vulnerable Populations; Work; base; chronic pain; clinical pain; cost; design; distraction; efficacy outcomes; efficacy testing; experience; experimental group; group intervention; guided inquiry; improved; improved outcome; insight; intervention effect; mHealth; morphine equivalent; nondrug therapy; opioid sparing; opioid use; outcome prediction; overdose death; pain self-management; predictive modeling; primary outcome; recruit; response; rumination; secondary outcome; sex; side effect; stressor; success; therapy design

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.

项目摘要/摘要 我们的长期目标是减少阿片类药物的使用，减轻压力，改善镰状细胞病(SCD)的疼痛控制 通过自我管理放松/分心练习(RDE)进行干预，名为You Cope，We 支持(YCWS)。患有SCD的美国人反复发作急性和慢性疼痛，两者都是 会因压力而加剧。在我们先前形成性研究的成功基础上，我们现在提出一个很好的- 设计了适当的研究，以测试YCWS对结果(疼痛强度、压力强度、 阿片类药物的使用)。我们建议招募170名成年人进行短暂性脑缺血发作的随机对照试验。 YCWS对结局的长期(8周)和长期(6个月)影响(疼痛、压力和阿片类药物使用)。 根据最严重的疼痛强度(&lt；=5；&gt；5)分层，我们将患者随机分配到组：85人为对照组(自身 监测结果+警报/提醒)，85个为试验性(自我监测结果+ 警报/提醒+使用YCWS[RDE+支持])。我们将要求参与者每天报告结果。在.期间 第1-8周，我们将通过电话、短信或电子邮件向这两个组发送系统生成的警报/提醒，以 促进数据输入(两组)和干预使用支持(试验性)。如果病人没有进入 数据24小时后，研究支持人员将联系他/她进行数据录入故障排除(两组)和 YCWS使用(试验性)。我们将对参与者的在线活动进行时间标记和跟踪，以了解研究 并就工作人员的可接受性和系统产生的支持进行离职面谈。我们将分析 使用混合效应回归模型(短期、长期)处理重复测量的数据 随着时间的推移，并利用机器学习来构建和评估预测结果的模型。具体目标 目标1：确定青年会的短期效果。假设：在前8周，与 对照组，试验组将报告疼痛强度(主要结果，0-10分)和 次要结果--压力强度(0-10分)和阿片类药物的使用(口服吗啡当量[OME])。目标2： 以确定青年会的长期效果。假设：在3-6个月，与对照组相比， 试验组将报告疼痛强度(主要结果，0-10分)和次要疼痛强度的减少 结果--压力强度(0-10分)和阿片类药物的使用(口服吗啡当量[OME])。目标3 (探索性)：使用机器学习，开发和评估预测患者结局的模型 根据他们的小组任务和个人(例如，自我效能感、性别、教育、家庭收入、电脑 经验等)和环境特征(例如，距离护理的距离、细胞连接的质量等)。 研究结果将指导未来关于实现移动健康的青年服务中心自我管理的研究 成人SCD对现实世界的干预。这些发现也将指导人们发现理想的分娩方式 YCWS的方法及受益患者的个人和环境特征 有效控制SCD等疼痛类型及其对心理的影响。