Mortenson W Ben, Mills Patricia Branco, Adams Jared, Singh Gurkaran, MacGillivray Megan, Sawatzky Bonita
Department of Occupational Sciences and Occupational Therapy, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
GF Strong Rehabilitation Centre, Vancouver, BC, Canada.
JMIR Res Protoc. 2018 Nov 14;7(11):e11069. doi: 10.2196/11069.
Most people with spinal cord injury will develop secondary complications with potentially devastating consequences. Self-management is a key prevention strategy for averting the development of secondary complications and their recurrence. Several studies have shown that self-management programs improve self-management behaviors and health outcomes in individuals living with chronic conditions such as asthma, diabetes, hypertension, and arthritis. Given the burgeoning health care costs related to secondary complications, we developed an alternative electronic health-based implementation to facilitate the development of self-management skills among people with spinal cord injury.
This study aims to evaluate the efficacy of a self-management app in spinal cord injury populations. The primary outcome is attainment of self-selected, self-management goals. Secondary outcomes include increases in general and self-management self-efficacy and reductions in self-reported health events, health care utilization, and secondary complications related to spinal cord injury. This study also aims to explore how the intervention was implemented and how the app was experienced by end users.
This study will employ a mix of qualitative and quantitative methods. The quantitative portion of our study will involve a rater-blinded, randomized controlled trial with a stepped wedge design (ie, delayed intervention control group). The primary outcome is successful goal attainment, and secondary outcomes include increases in self-efficacy and reductions in self-reported health events, health care utilization, and secondary conditions related to spinal cord injury. The qualitative portion will consist of semistructured interviews with a subsample of the participants.
We expect that the mobile self-management app will help people with spinal cord injury to attain their self-management goals, improve their self-efficacy, reduce secondary complications, and decrease health care utilization.
If the results are positive, this study will produce credible new knowledge describing multiple outcomes that people with spinal cord injury realize from an app-based self-management intervention and support its implementation in clinical practice.
ClinicalTrials.gov NCT03140501; http://clinicaltrials.gov/ct2/show/NCT03140501 (Archived by WebCite at http://www.webcitation.org/73Gw0ZlWZ).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/11069.
大多数脊髓损伤患者会出现继发性并发症,可能带来毁灭性后果。自我管理是预防继发性并发症发生及其复发的关键策略。多项研究表明,自我管理项目可改善患有哮喘、糖尿病、高血压和关节炎等慢性病患者的自我管理行为及健康状况。鉴于与继发性并发症相关的医疗费用不断攀升,我们开发了一种基于电子健康的替代方案,以促进脊髓损伤患者自我管理技能的发展。
本研究旨在评估一款自我管理应用程序对脊髓损伤人群的疗效。主要结局是实现自我选择的自我管理目标。次要结局包括一般自我管理效能感和自我管理效能感的提高,以及自我报告的健康事件、医疗保健利用率和与脊髓损伤相关的继发性并发症的减少。本研究还旨在探讨干预措施的实施方式以及最终用户对该应用程序的体验。
本研究将采用定性和定量相结合的方法。我们研究的定量部分将包括一项采用阶梯楔形设计(即延迟干预对照组)的评分者盲法随机对照试验。主要结局是成功实现目标,次要结局包括自我效能感的提高以及自我报告的健康事件、医疗保健利用率和与脊髓损伤相关的继发性疾病的减少。定性部分将包括对部分参与者进行半结构化访谈。
我们预计,这款移动自我管理应用程序将帮助脊髓损伤患者实现自我管理目标,提高自我效能感,减少继发性并发症,并降低医疗保健利用率。
如果结果呈阳性,本研究将产生可靠的新知识,描述脊髓损伤患者从基于应用程序的自我管理干预中实现的多种结局,并支持其在临床实践中的应用。
ClinicalTrials.gov NCT03140501;http://clinicaltrials.gov/ct2/show/NCT03140501(由WebCite存档于http://www.webcitation.org/73Gw0ZlWZ)。
国际注册报告识别码(IRRID):PRR1-10.2196/11069。