An App-based Versus a Web-based Self-management Intervention or Usual Care in People With Low Back and/or Neck Pain on a Waiting List for Hospital-based Outpatient Rehabilitation
NCT ID: NCT04463043
Last Updated: 2022-09-23
Study Results
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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COMPLETED
NA
294 participants
INTERVENTIONAL
2020-07-09
2021-12-03
Brief Summary
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Detailed Description
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A total of 279 participants will be recruited and randomly allocated to one of the three groups: 1) the selfBACK app in addition to usual care; 2) the e-Help webpage in addition to usual care; and 3) usual care only. Participants who receive either the selfBACK app and the e-Help webpage will be allowed to seek care, treatment or help elsewhere as usual.
Self-reported outcome measures will be collected through web-based questionnaires at three follow-up time points: 1) 6 weeks; 2) 3 months (primary endpoint); and 3) 6 months. In addition, participants receiving the selfBACK app will be asked a set of weekly tailoring questions to individualize self-management plans. Objective registry based data linked to social security number in Norway will be used to investigate health care consumption and sickness absence at 1 year (and up to 5 years).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SelfBACK app
The selfBACK app in addition to usual care
SelfBACK app
The selfBACK is an evidence-based and data-driven decision support system (DSS) to support self-management of low back and neck pain delivered via a smartphone app. The selfBACK app provides individually tailored self-management plans to participants on a weekly basis by matching the participant's health information with targeted educational messages, physical activity advices and exercise recommendations via the DSS.
Usual care
Usual care refers to seeking care or receiving treatments or help as usual.
e-Help webpage
The e-Help webpage in addition to usual care
e-Help webpage
The e-Help is an evidence-based web-based resource to support self-management of low back and neck pain. The e-Help webpage provides evidence-based self-management content equivalent to the selfBACK including educational messages, physical activity and exercise recommendations. Instructions on how to compose exercise programs will be given to participants, however no tailored self-management support will be offered in this solution.
Usual care
Usual care refers to seeking care or receiving treatments or help as usual.
Usual care
Usual care only
Usual care
Usual care refers to seeking care or receiving treatments or help as usual.
Interventions
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SelfBACK app
The selfBACK is an evidence-based and data-driven decision support system (DSS) to support self-management of low back and neck pain delivered via a smartphone app. The selfBACK app provides individually tailored self-management plans to participants on a weekly basis by matching the participant's health information with targeted educational messages, physical activity advices and exercise recommendations via the DSS.
e-Help webpage
The e-Help is an evidence-based web-based resource to support self-management of low back and neck pain. The e-Help webpage provides evidence-based self-management content equivalent to the selfBACK including educational messages, physical activity and exercise recommendations. Instructions on how to compose exercise programs will be given to participants, however no tailored self-management support will be offered in this solution.
Usual care
Usual care refers to seeking care or receiving treatments or help as usual.
Eligibility Criteria
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Inclusion Criteria
* Own and use a smartphone with internet access to download the mobile application
* Able to provide informed consent
Exclusion Criteria
* Unable to take part in exercise/physical activity, e.g. non-ambulatory patients, use of walking aids, unable to get up and down the floor independently
* Unable to speak and/or read Norwegian
* Unable to complete the baseline questionnaire
18 Years
ALL
No
Sponsors
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St. Olavs Hospital
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Siri Forsmo, phd prof
Role: STUDY_DIRECTOR
Norwegian University of Science and Technology
Locations
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Tverrfaglig poliklinikk rygg/nakke/skulder, St. Olavs Hospital
Trondheim, , Norway
Countries
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References
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Marcuzzi A, Bach K, Nordstoga AL, Bertheussen GF, Ashikhmin I, Boldermo NO, Kvarner EN, Nilsen TIL, Marchand GH, Ose SO, Aasdahl L, Kaspersen SL, Bardal EM, Borke JB, Mork PJ, Gismervik S. Individually tailored self-management app-based intervention (selfBACK) versus a self-management web-based intervention (e-Help) or usual care in people with low back and neck pain referred to secondary care: protocol for a multiarm randomised clinical trial. BMJ Open. 2021 Sep 13;11(9):e047921. doi: 10.1136/bmjopen-2020-047921.
Marcuzzi A, Klevanger NE, Aasdahl L, Gismervik S, Bach K, Mork PJ, Nordstoga AL. An Artificial Intelligence-Based App for Self-Management of Low Back and Neck Pain in Specialist Care: Process Evaluation From a Randomized Clinical Trial. JMIR Hum Factors. 2024 Jul 9;11:e55716. doi: 10.2196/55716.
Marcuzzi A, Nordstoga AL, Bach K, Aasdahl L, Nilsen TIL, Bardal EM, Boldermo NO, Falkener Bertheussen G, Marchand GH, Gismervik S, Mork PJ. Effect of an Artificial Intelligence-Based Self-Management App on Musculoskeletal Health in Patients With Neck and/or Low Back Pain Referred to Specialist Care: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2320400. doi: 10.1001/jamanetworkopen.2023.20400.
Other Identifiers
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64084
Identifier Type: -
Identifier Source: org_study_id
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