Kidd Sean, McKenzie Kwame, Wang Wei, Agrawal Sacha, Voineskos Aristotle
Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
Centre for Addiction and Mental Health, Toronto, ON, Canada.
JMIR Res Protoc. 2021 Jan 25;10(1):e24736. doi: 10.2196/24736.
In schizophrenia spectrum populations, adherence to treatment is poor, community-based supports are limited, and efforts to foster illness self-management have had limited success. These challenges contribute to frequent, lengthy, and costly hospital readmissions and poor functional outcomes. Digital health strategies, in turn, hold considerable promise in the effort to address these problems.
This feasibility trial will examine a digital health platform called App4Independence (A4i), which was designed to enhance illness self-management and treatment engagement for individuals with schizophrenia.
Feasibility metrics in this single-blind, randomized trial include study recruitment and retention, rate of technology use, safety, and utility in clinical interactions. Other outcome metrics include symptomatology, treatment adherence, patient-provider alliance, and quality of life. In this trial, 160 study participants with schizophrenia spectrum diagnoses will be randomized to either treatment or control conditions, with pretest-posttest outcomes measured over a 6-month period.
This study was funded by the Canadian Institutes of Health Research in January 2020 and received Institutional Review Board approval on August 13, 2020. This study plans to begin recruiting in January 2021 and will be completed within 3 years. Data collection is projected to begin in January 2021.
This research will provide critical information for the development of this new technology in the larger effort to address a key problem in the schizophrenia field-how to leverage technology to enhance illness self-management and care engagement in resource-limited service contexts.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/24736.
在精神分裂症谱系人群中，治疗依从性差，社区支持有限，促进疾病自我管理的努力成效有限。这些挑战导致频繁、长期且昂贵的医院再入院以及功能结局不佳。而数字健康策略在解决这些问题方面具有很大潜力。
这项可行性试验将研究一个名为“独立应用程序（App4Independence，A4i）”的数字健康平台，该平台旨在增强精神分裂症患者的疾病自我管理和治疗参与度。
这项单盲随机试验的可行性指标包括研究招募与保留、技术使用频率、安全性以及在临床互动中的实用性。其他结局指标包括症状学、治疗依从性、医患联盟和生活质量。在该试验中，160名被诊断为精神分裂症谱系的研究参与者将被随机分配到治疗组或对照组，在6个月的时间内测量前后测结果。
本研究于2020年1月获得加拿大卫生研究院资助，并于2020年8月13日获得机构审查委员会批准。本研究计划于2021年1月开始招募，并将在3年内完成。预计数据收集将于2021年1月开始。
这项研究将为这项新技术的开发提供关键信息，以更大力度解决精神分裂症领域的一个关键问题——如何在资源有限的服务环境中利用技术增强疾病自我管理和护理参与度。
国际注册报告识别码（IRRID）：PRR1-10.2196/24736
