Comparing Satisfaction With a Participatory Driven Web-application and a Standard Website

Study Overview
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Brief Summary
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This project studies the effects of involving patients in the development of a web-application.

Detailed Description
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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).

Official Title
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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

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Information material


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Contacting general practice with low back pain Exclusion Criteria: Spinal stenosis Spine fractures Cauda equina syndrome Spinal malignancy Osteoporosis Spondyloarthritis Without Danish reading skills Without internet access Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Allocation of patients 1:1 to the new web-application or to Patient's Handbook
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New web-application<br>Information material developed in a participatory design together with patients. | Other: Information material<br>* Online web-application developed together with patients with low back pain<br>|
| Experimental: Patient Handbook<br>Public available information. | Other: Information material<br>* Online web-application developed together with patients with low back pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General satisfaction | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional improvement | Roland Morris functional disability score (RMDQ, the Patrick version, 0-23 points) | 12 weeks | 
| Pain intensity | Numerical pain rating of current pain (0-10 Points, rating from 'no pain' to 'maximal pain' ) | 1, 2, 4, 8, and 12 weeks | 
| Improvement in self-rated health | EQ-5D-5L (EuroQol - 5 Diminsions - 5 Levels) | 12 weeks | 
| Employment status | Self reported current employment status (yes/no) | 12 weeks | 
| Sick leave | Self reported number of hours of sick leave during the study | 12 weeks | 
| Contacts to general practice | Self reported number of general practice contacts since study inclusion | 12 weeks | 
| Contacts to primary care physiotherapists | Self reported number of physiotherapy contacts since study inclusion | 12 weeks | 
| Contacts to primary care chiropractors | Self reported number of chiropractor contacts since study inclusion | 12 weeks | 
| Contacts to secondary care | Contact to secondary care because of low back pain during the study (yes/no) | 12 weeks | 
| Cost utility analysis | A analysis comparing the intervention group with the control group from a healthcare perspective. Including primary care costs such as public paid costs for GP contacts, physiotherapy services, and chiropractic services. Quality adjusted life years (QALYs) will be applied as measure of effect based on EQ-5D-5L. We will not include costs for developing and maintaining the new technology or other protocol driven costs. Based on the relative short time-horizon costs and effects will not be discounted. | 12 weeks | 
| Specific satisfaction | For further exploration of reasons for the primary outcome we include a question regarding the general satisfaction with the web-application (10-0) and detailed questions/items regarding satisfaction with design (very, some, little, none), satisfaction with customisation (very, some, little, none ), satisfaction with usability (very, some, little, none ), satisfaction with readability (very, some, little, none), and satisfaction with credibility (very, some, little, none). It is only possible to tick off one box to each item, if the patient change decision while filling in the online questionnaire, another box can be ticked off and the first choice will automatically delete. Furthermore, these items will be validated against the primary outcome. | 1, 2, 4, 8, and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain