A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY
赞助:
University of Southern Denmark
合作者:
信息的提供 (责任方):
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追踪信息 | |||
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首次提交日期 ICMJE | August 10, 2018 | ||
首次发布日期e ICMJE | October 5, 2018 | ||
最后更新发布日期 | October 5, 2018 | ||
预计研究开始日期 ICMJE | August 20, 2018 | ||
预计主要完成日期 | December 2018 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Roland Morris Disability Questionnaire[ Time Frame: change from baseline to 6 weeks ] The primary outcome is the Roland Morris Disability Questionnaire (RMDQ) assessing pain-related disability. The questionnaire includes 24 items asking participants to indicate if they experience functional impairments by answering "yes" or "no" to a series of descriptions of functional abilities with higher scores indicating higher level of disability. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY | ||
正式标题 ICMJE | A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY | ||
简要概况 | The pilot study precedes a larger randomized controlled trial, to be starting in February 2019. In this pilot study all participants are allocated to the intervention group. The intervention consists of a digital decision support system delivering a weekly plan of suggested activities that the participant can use to self-manage their low back pain. The plan is presented to the participant in the selfBACK app. |
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详细说明 | The selfBACK intervention consists of the selfBACK system, that provides the participants with an individually tailored weekly plan of suggested activities to use in their self-management of low back pain. The SELFBACK system constitutes a data-driven predictive decision support system that uses Case-Based Reasoning methodology to capture and reuse participant cases in order to suggest the most suitable self-management plan for participants. The selfBACK system is an intelligent system that will adjust the suggested self-management plan to the individual participants by using the information available on the participant (baseline questionnaires), weekly self-reported of changes in health status through the app, and data on physical activity via the step-detecting wristband. The weekly plan includes three categories of content; 1) information/education, 2) physical activity monitoring through wearing a step-detecting wristband, and 3) strength and flexibility exercises. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: This study is a pilot study preceding a randomized controlled trial. In the pilot study all enrolled participants are offered the intervention. 盲法: Interventional 盲法描述:Since there is no randomization, all participants receive the intervention. Consequently, there is no blinding. 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Recruiting | ||
预计入组 ICMJE |
80 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | December 2018 | ||
预计主要完成日期 | December 2018 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Seeking care from primary health-care practice or a specialised outpatient hospital facility (DK) for non-specific LBP within the past 8 weeks - LBP of any duration - Mild-to severe pain-related disability rated as 16 or below on the PROMIS-PF4 function scale. - Age: ≥18 years - Own and regularly use a smart phone (with at least Android 7.0 or iOS11.0) with internet access (Wi-Fi and/or mobile data) - Have a working email address and have access to a computer with internet access to complete questionnaires in a web browser. Exclusion Criteria: - Not interested - Unable to speak, read or write in the national language (Danish/ Norwegian) - Cognitive impairment or learning disabilities - Pathology, such as fracture, cancer, inflammatory diseases, and signs of radiculopathy (severe leg pain, loss of leg strength, or loss of or altered sensation in a myotomal or dermatomal distribution) - Serious mental illness, such as major depression, schizophrenia, and psychosis - Terminal illness - Unable to take part in exercise/physical activity (such as non-ambulatory patients, use of walking aids/assistance, unable to get down and up from the floor independently) - Fibromyalgia (diagnosed by a Health Care Professional) - Pregnancy - Previous back surgery - Ongoing participation in other research trials for LBP management | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Denmark|Norway | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | , | ||
研究赞助商 ICMJE | University of Southern Denmark | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | |||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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