NCT03088774

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
3.8 years until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

Same day

First QC Date

March 17, 2017

Last Update Submit

January 25, 2021

Conditions

Low Back Pain

Keywords

Low back pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Functional improvement

    12 weeks

  • Pain intensity

    1, 2, 4, 8, and 12 weeks

  • Improvement in self-rated health

    12 weeks

  • Employment status

    12 weeks

  • Sick leave

    12 weeks

  • +6 more secondary outcomes

Study Arms (2)

New web-application

EXPERIMENTAL

Information material developed in a participatory design together with patients.

Other: Information material

Patient Handbook

EXPERIMENTAL

Public available information.

Other: Information material

Interventions

Information materialOTHER

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

New web-applicationPatient Handbook

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Contacting general practice with low back pain

You may not qualify if:

  • Spinal stenosis
  • Spine fractures
  • Cauda equina syndrome
  • Spinal malignancy
  • Osteoporosis
  • Spondyloarthritis
  • Without Danish reading skills
  • Without internet access
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 31924258DERIVED

  • 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.

    PMID: 30045749DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Allan Riis, PhD

    Research unit for General Practice in Aalborg, Denmark

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Allocation of patients 1:1 to the new web-application or to Patient's Handbook
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post doc

Study Record Dates

First Submitted

March 17, 2017

First Posted

March 23, 2017

Study Start

January 25, 2021

Primary Completion

January 25, 2021

Study Completion

January 25, 2021

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share