Clinical trial NCT03088774: Comparing Satisfaction With a Participatory Driven Web-application and a Standard Website
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: The Novo Nordic Foundation
name: The Danish Rheumatism Association
First posted: 2017-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation of patients 1:1 to the new web-application or to Patient's Handbook
Primary purpose: TREATMENT

Brief summary: This project studies the effects of involving patients in the development of a web-application.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: General satisfaction
timeFrame: 12 weeks
Secondary outcomes:
measure: Functional improvement
timeFrame: 12 weeks
measure: Pain intensity
timeFrame: 1, 2, 4, 8, and 12 weeks
measure: Improvement in self-rated health
timeFrame: 12 weeks
measure: Employment status
timeFrame: 12 weeks
measure: Sick leave
timeFrame: 12 weeks
measure: Contacts to general practice
timeFrame: 12 weeks
measure: Contacts to primary care physiotherapists
timeFrame: 12 weeks
measure: Contacts to primary care chiropractors
timeFrame: 12 weeks
measure: Contacts to secondary care
timeFrame: 12 weeks
measure: Cost utility analysis
timeFrame: 12 weeks
measure: Specific satisfaction
timeFrame: 1, 2, 4, 8, and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Research unit for General Practice in Aalborg, Denmark
name: Allan Riis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Riis A, Rathleff MS, Hartvigsen J, Thomsen JL, Afzali T, Jensen MB. Feasibility study on recruitment in general practice for a low back pain online information study (part of the ADVIN Back Trial). BMC Res Notes. 2020 Jan 10;13(1):24. doi: 10.1186/s13104-020-4894-8.
citation: Riis A, Hartvigsen J, Rathleff MS, Afzali T, Jensen MB. Comparing satisfaction with a participatory driven web-application and a standard website for patients with low back pain: a study protocol for a randomised controlled trial (part of the ADVIN Back Trial). Trials. 2018 Jul 25;19(1):399. doi: 10.1186/s13063-018-2795-0.