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

基本信息

批准号：
10255994
负责人：
Miriam Omelebele Ezenwa
金额：
$ 51.61万
依托单位：
UNIVERSITY OF FLORIDA
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：
2020-09-07 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10255994
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 secondary outcome sex side effect stressor success therapy design

项目摘要

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.

项目概要/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) 疼痛控制通过自我管理放松/分散注意力练习 (RDE) 进行干预，名为“你应对，我们” 支持（YCWS）。患有 SCD 的美国人患有反复发作的急性和慢性疼痛，这两种疼痛因压力而加剧。基于我们之前形成性研究的成功，我们现在提出了一个良好的方案设计的、适当动力的研究来测试 YCWS 对结果（疼痛强度、压力强度、成人 SCD 患者使用阿片类药物）。我们建议招募 170 名成年人进行短期随机对照试验 YCWS 对结果（疼痛、压力和阿片类药物使用）的短期（8 周）和长期（6 个月）影响。根据最严重的疼痛强度（<=5；>5）分层，我们将患者随机分配至组：85 组至对照组（自我监测结果 + 警报/提醒），以及 85 至实验性（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。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（实验性）。如果病人不进入 24小时后数据，研究支持人员将联系他/她进行数据输入故障排除（两组）和 YCWS 使用（实验性）。我们将为参与者的在线活动添加时间戳并跟踪以了解该研究背景情况并就工作人员的可接受性和系统生成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）的数据来解释重复测量随着时间的推移，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 YCWS 的短期效果。假设：在前 8 周内，与对照组、实验组将报告疼痛强度降低（主要结果，0-10 级）次要结果——压力强度（0-10 级）和阿片类药物的使用（口服吗啡当量 [OME]）。目标 2：确定 YCWS 的长期影响。假设：在第 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 级）和次要结果结果——压力强度（0-10 级）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，开发和评估基于预测患者结果的模型关于他们的小组作业和个人（例如，自我效能、性别、教育、家庭收入、计算机经验等）和环境特征（例如，距护理的距离、细胞连接的质量等）。研究结果将指导未来关于实施移动医疗支持的 YCWS 自我管理的研究患有 SCD 的成年人对现实世界的干预。研究结果还将指导理想分娩方式的发现 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的疼痛和其他类型的疼痛及其心理影响。