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Trial record 8 of 660 for:    applied AND web-

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

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ClinicalTrials.gov Identifier: NCT03088774
Recruitment Status : Not yet recruiting
First Posted : March 23, 2017
Last Update Posted : July 3, 2019
Sponsor:
Collaborators:
The Novo Nordic Foundation
The Danish Rheumatism Association
Information provided by (Responsible Party):
Allan Riis, Aalborg University Hospital

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

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Information material Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Allocation of patients 1:1 to the new web-application or to Patient's Handbook
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
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
Estimated Study Start Date : December 15, 2019
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : November 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: New web-application
Information material developed in a participatory design together with patients.
Other: Information material
Online web-application developed together with patients with low back pain

Experimental: Patient Handbook
Public available information.
Other: Information material
Online web-application developed together with patients with low back pain




Primary Outcome Measures :
  1. General satisfaction [ Time Frame: 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.


Secondary Outcome Measures :
  1. Functional improvement [ Time Frame: 12 weeks ]
    Roland Morris functional disability score (RMDQ, the Patrick version, 0-23 points)

  2. Pain intensity [ Time Frame: 1, 2, 4, 8, and 12 weeks ]
    Numerical pain rating of current pain (0-10 Points, rating from 'no pain' to 'maximal pain' )

  3. Improvement in self-rated health [ Time Frame: 12 weeks ]
    EQ-5D-5L (EuroQol - 5 Diminsions - 5 Levels)

  4. Employment status [ Time Frame: 12 weeks ]
    Self reported current employment status (yes/no)

  5. Sick leave [ Time Frame: 12 weeks ]
    Self reported number of hours of sick leave during the study

  6. Contacts to general practice [ Time Frame: 12 weeks ]
    Self reported number of general practice contacts since study inclusion

  7. Contacts to primary care physiotherapists [ Time Frame: 12 weeks ]
    Self reported number of physiotherapy contacts since study inclusion

  8. Contacts to primary care chiropractors [ Time Frame: 12 weeks ]
    Self reported number of chiropractor contacts since study inclusion

  9. Contacts to secondary care [ Time Frame: 12 weeks ]
    Contact to secondary care because of low back pain during the study (yes/no)

  10. Cost utility analysis [ Time Frame: 12 weeks ]
    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.

  11. Specific satisfaction [ Time Frame: 1, 2, 4, 8, and 12 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088774


Contacts
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Contact: Allan Riis, PhD +45 20823660 ariis@dcm.aau.dk

Sponsors and Collaborators
Aalborg University Hospital
The Novo Nordic Foundation
The Danish Rheumatism Association
Investigators
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Principal Investigator: Allan Riis, PhD Research unit for General Practice in Aalborg, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allan Riis, Post doc, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03088774     History of Changes
Other Study ID Numbers: AllanRiis_4
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Allan Riis, Aalborg University Hospital:
Low back pain

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms