A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Roland Morris Disability Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Since there is no randomization, all participants receive the intervention. Consequently, there is no blinding.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Usual care + selfBACK
Participants will use the selfBACK system and app
干预措施: Usual care + selfBACK (Other)
结局指标
主要结局
Roland Morris Disability Questionnaire
时间窗: 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.
次要结局
- Perceived Stress Scale(change from baseline to 6 weeks)
- Pain intensity(change from baseline to 6 weeks)
- The Fear avoidance Belief Questionnaire(change from baseline to 6 weeks)
- Pain Self-Efficacy Questionnaire(change from baseline to 6 weeks)
- Activity limitation(change from baseline to 6 weeks)
- Workability(change from baseline to 6 weeks)
- Saltin-Grimby Physical Activity Level Scale(change from baseline to 6 weeks)
- Health-related Quality of Life(change from baseline to 6 weeks)
- Patient Specific Functional Scale(change from baseline to 6 weeks)
- Sleep(change from baseline to 6 weeks)
- Brief Illness Perception Questionnaire(change from baseline to 6 weeks)
- Patient Health Questionnaire-8(change from baseline to 6 weeks)
- Patients Global Perceived effect(6 weeks)
- Patient Acceptable Symptom State(6 weeks.)
- Virtual Care Climate Questionnaire(6 weeks)
- User ratings(6 weeks)