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

NCT ID: NCT03088774

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-25

Study Completion Date

2021-01-25

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).

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Allocation of patients 1:1 to the new web-application or to Patient's Handbook
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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.

Study Groups

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New web-application

Information material developed in a participatory design together with patients.

Group Type EXPERIMENTAL

Information material

Intervention Type OTHER

Online web-application developed together with patients with low back pain

Patient Handbook

Public available information.

Group Type EXPERIMENTAL

Information material

Intervention Type OTHER

Online web-application developed together with patients with low back pain

Interventions

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Information material

Online web-application developed together with patients with low back pain

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Novo Nordic Foundation

OTHER

Sponsor Role collaborator

The Danish Rheumatism Association

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Allan Riis

Post doc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allan Riis, PhD

Role: PRINCIPAL_INVESTIGATOR

Research unit for General Practice in Aalborg, Denmark

References

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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.

Reference Type DERIVED
PMID: 31924258 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30045749 (View on PubMed)

Other Identifiers

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AllanRiis_4

Identifier Type: -

Identifier Source: org_study_id

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