Comparing Satisfaction With a Participatory Driven Web-application and a Standard Website for Patients With Low Back Pain: a Study Protocol of a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- General satisfaction
研究概览
简要总结
This project studies the effects of involving patients in the development of a web-application.
详细描述
The point-prevalence of low back pain (LBP) has been estimated to 9.4 % and LBP is in many countries the most frequent reason to consult a general practitioner. However, general practitioners are under pressure with increasing workloads. The increasing number of patients and the typical 10-15 minutes of available time for each patient are challenging the provision of sufficient information and advice. According to international guidelines information and advice are recommended for every patient with LBP, therefore, new methods to support general practitioners (GPs) are very much needed. Online technologies give new opportunities to extend the treatment. Furthermore, involving patients with LBP in the development of online information material may produce more user friendly content and design and thereby increasing patients' acceptance and usage. Thus, optimizing clinical outcome. This project will study patients' satisfaction and clinical outcomes of a web-application for patients with LBP consulted in general practice compared to best existing technology (the Patient Handbook).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The allocation sequence will be delivered by the statistician group at Aalborg University Hospital and delivered to a IT consultant at ProData (Viby, J, Denmark) and integrated in the web-application. The researchers conducting the analysis will be blinded. During the project, data will be stored on a server placed at Aalborg University. Another member of the author Group will prepare a data set with a dummy variable for allocation without free text information from patients and make this data set available for the assessors to analyse. Patients will be aware of their allocation. General practitioners will only be aware of the allocation if the patient chooses to tell it to the general practitioner.
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
- •Contacting general practice with low back pain
排除标准
- •Spinal stenosis
- •Spine fractures
- •Cauda equina syndrome
- •Spinal malignancy
- •Osteoporosis
- •Spondyloarthritis
- •Without Danish reading skills
- •Without internet access
- •Pregnant women
研究组 & 干预措施
New web-application
Information material developed in a participatory design together with patients.
干预措施: Information material (Other)
Patient Handbook
Public available information.
干预措施: Information material (Other)
结局指标
主要结局
General satisfaction
时间窗: 12 weeks
The question: 'how likely is it that you would recommend this web-application to a friend or colleague?' will be applied to measure satisfaction. The patients will be asked to choose between 11 boxes displayed on a horizontal line (10-0 Points, higher score indicating more satisfaction). The scales will be labelled to the left at 10 (extremely likely) and at the right side as 0 (not at all likely). It is only possible to tick off one box, if the patient change decision while filling in the online questionnaire, another box can be ticked off and the first choice will automatically delete. Responses of 10-9 are grouped as 'satisfied' of the web-application and patients replying 8-0 will be grouped as 'not satisfied'. The proportion of patients being satisfied after 12 weeks is the primary analysis. The proportion of patients being satisfied after 1, 2, 4, and 8 weeks will be carried out as secondary analyses.
次要结局
- Improvement in self-rated health(12 weeks)
- Employment status(12 weeks)
- Sick leave(12 weeks)
- Contacts to secondary care(12 weeks)
- Cost utility analysis(12 weeks)
- Pain intensity(1, 2, 4, 8, and 12 weeks)
- Contacts to general practice(12 weeks)
- Contacts to primary care chiropractors(12 weeks)
- Contacts to primary care physiotherapists(12 weeks)
- Functional improvement(12 weeks)
- Specific satisfaction(1, 2, 4, 8, and 12 weeks)
研究者
Allan Riis
Post doc
Aalborg University Hospital