A Stress and Pain Self-management mHealth App for Adult Outpatients With Sickle Cell Disease: Protocol for a Randomized Controlled Study.
A Stress and Pain Self-management mHealth App for Adult Outpatients With Sickle Cell Disease: Protocol for a Randomized Controlled Study.
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针对镰状细胞病的成人门诊患者的压力和疼痛自我管理MHealth应用程序：随机对照研究的方案。
DOI：
10.2196/33818
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发表时间：
2022-07-29
影响因子：
1.7
通讯作者：
中科院分区：
文献类型：
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作者：
本文描述了一项对诊断为镰状细胞病(SCD)的成人进行自我管理干预的随机对照试验的研究方案。患有SCD的人会经历终身反复发作的急性和慢性疼痛，这些疼痛会因压力而加剧。这项研究旨在通过一种名为You Cope，We Support(YCWS)的自我管理放松练习的干预，通过减少阿片类药物的使用来减轻压力，改善SCD疼痛控制。在我们以前形成性研究结果的基础上，这项研究旨在测试YCWS对SCD成人应激强度、疼痛强度和阿片类药物使用的疗效。一项关于YCWS对压力、疼痛和阿片类药物使用的短期(8周)和长期(6个月)影响的随机对照试验将在170名患有SCD的成年人中进行。患者将根据1：1的比例(按疼痛强度分层[≤5或>；5])随机分为试验组(自我监测结果、警报或提醒，并使用YCWS[放松和分心练习和支持])或对照组(自我监测结果和警报或提醒)。患者将被要求每天报告结果。在第1周到第8周，两组患者都将通过电话、短信或电子邮件收到系统生成的警报或提醒，以促进数据输入(两组)和干预使用支持(试验性)。如果参与者在24小时后没有输入数据，研究支持人员将联系他们进行数据输入故障排除(两组)和YCWS使用(试验性)。我们将对患者在网络上的活动进行时间标记和跟踪，以了解研究背景，并就系统生成的支持和工作人员支持的可接受性进行离职访谈。这项研究得到了我们的机构审查委员会的批准。本研究于2020年获得美国国立卫生研究院国家护理研究所资助。这项研究于2021年3月开始，将于2025年6月完成。截至2022年4月，我们已经招募了45.9%(78/170)的患者。我们将使用混合效应回归模型(短期和长期)来分析数据，以说明随着时间的推移重复测量的情况，并使用机器学习来构建和评估预测模型。由于新冠肺炎的流行，这项研究被修改为允许邮寄同意流程、通过电子邮件或Zoom视频会议进行基于互联网的同意流程、由联邦快递提供的设备，以及通过Zoom视频会议进行培训。我们希望干预组报告疼痛强度(主要结果；0-10评分)和压力强度(0-10评分)和阿片类药物使用(Wisepill事件用药监测系统)的减少，这是次要结果。我们的研究将有助于促进非阿片类药物治疗的使用，如引导放松和分散技术来控制SCD疼痛。临床试验.gov NCT04484272；https://clinicaltrials.gov/ct2/show/NCT04484272 pr1-10.2196/33818
This paper describes the research protocol for a randomized controlled trial of a self-management intervention for adults diagnosed with sickle cell disease (SCD). People living with SCD experience lifelong recurrent episodes of acute and chronic pain, which are exacerbated by stress. This study aims to decrease stress and improve SCD pain control with reduced opioid use through an intervention with self-management relaxation exercises, named You Cope, We Support (YCWS). Building on our previous findings from formative studies, this study is designed to test the efficacy of YCWS on stress intensity, pain intensity, and opioid use in adults with SCD. A randomized controlled trial of the short-term (8 weeks) and long-term (6 months) effects of YCWS on stress, pain, and opioid use will be conducted with 170 adults with SCD. Patients will be randomized based on 1:1 ratio (stratified on pain intensity [≤5 or >5]) to be either in the experimental (self-monitoring of outcomes, alerts or reminders, and use of YCWS [relaxation and distraction exercises and support]) or control (self-monitoring of outcomes and alerts or reminders) group. Patients will be asked to report outcomes daily. During weeks 1 to 8, patients in both groups will receive system-generated alerts or reminders via phone call, text, or email to facilitate data entry (both groups) and intervention use support (experimental). If the participant does not enter data after 24 hours, the study support staff will contact them for data entry troubleshooting (both groups) and YCWS use (experimental). We will time stamp and track patients’ web-based activities to understand the study context and conduct exit interviews on the acceptability of system-generated and staff support. This study was approved by our institutional review board. This study was funded by the National Institute of Nursing Research of the National Institutes of Health in 2020. The study began in March 2021 and will be completed in June 2025. As of April 2022, we have enrolled 45.9% (78/170) of patients. We will analyze the data using mixed effects regression models (short term and long term) to account for the repeated measurements over time and use machine learning to construct and evaluate prediction models. Owing to the COVID-19 pandemic, the study was modified to allow for mail-in consent process, internet-based consent process via email or Zoom videoconference, devices delivered by FedEx, and training via Zoom videoconference. We expect the intervention group to report reductions in pain intensity (primary outcome; 0-10 scale) and in stress intensity (0-10 scale) and opioid use (Wisepill event medication monitoring system), which are secondary outcomes. Our study will contribute to advancing the use of nonopioid therapy such as guided relaxation and distraction techniques for managing SCD pain. ClinicalTrials.gov NCT04484272; https://clinicaltrials.gov/ct2/show/NCT04484272 PRR1-10.2196/33818
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DOI：
10.1097/00044067-200002000-00002
发表时间：
2000-02-01
期刊：
AACN clinical issues
影响因子：
--
作者：
Corless, I B;Abrams, D;McGibbon, C A
通讯作者：
McGibbon, C A
影响因子：
20.3
作者：
Bernaudin, Francoise;Socie, Gerard;Gluckman, Eliane
通讯作者：
Gluckman, Eliane
影响因子：
2.6
作者：
Dyal, Brenda W.;Ezenwa, Miriam O.;Wilkie, Diana J.
通讯作者：
Wilkie, Diana J.
CDC规定慢性疼痛的阿片类药物的指南 - 美国，2016年。
DOI：
10.1001/jama.2016.1464
发表时间：
2016-04-19
期刊：
JAMA
影响因子：
--
作者：
Dowell D;Haegerich TM;Chou R
通讯作者：
Chou R
影响因子：
5.4
作者：
Atkin, K;Ahmad, WIU
通讯作者：
Ahmad, WIU