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Evaluation of a Web-based Platform for Osteoarthritis Treatment

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ClinicalTrials.gov Identifier: NCT03328741
Recruitment Status : Suspended (COVID-19)
First Posted : November 1, 2017
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Lund University

Study Description
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Brief Summary:
This study will compare the effects of a novel web-based program (Joint Academy) to regular face-to-face treatment (the BOA program) for people with osteoarthritis of the knee. Half of the participants will be randomized to the web-based program whilst the other half will receive regular face-to-face care.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Behavioral: Online Osteoarthritis treatment Behavioral: Face-to-face osteoarthritis treatment Not Applicable

Detailed Description:

According to national and international guidelines, osteoarthritis (OA) treatment consists of exercise and information. The face-to-face BOA program is a model to deliver this treatment at primary care facilities in Sweden. Presently less than 20% of people with OA receive adequate treatment. This may be due to lack of healthcare resources or people having trouble to fit their schedule to primary care opening hours. To facilitate a better OA care, alternative methods are therefore required.

A two-armed randomized clinical superiority trial will be performed to compare OA treatment by a web-based program, Joint Academy, with the traditional face-to-face BOA program in 270 adults with clinically verified OA. Using intention-to-treat analysis and per-protocol, evaluations will be performed at baseline, after 6 weeks and after 3, 6 and 12 months. The primary outcome is physical function. Secondary outcomes are joint pain, health-related quality of life, self-reported function, amount of time of physical activity/exercise and overall satisfaction. A health-economic analysis will also be performed. The primary endpoint will be at 12 months. Data will be monitored using web-based questionnaires in Joint Academy, and regular paper questionnaires for the face-to-face treatment.

Should the trial show superiority in favor of Joint Academy, an implementation of the web-based treatment would benefit both patient and society at large, since Joint Academy entails a more flexible treatment in regards to time and location, and is not as costly per-patient as regular face-to-face treatment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of a Web-based Platform for Osteoarthritis Treatment - a Randomized Clinical Trial
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Joint Academy
Online osteoarthritis treatment
 Behavioral: Online Osteoarthritis treatment
6 week online-program
Other Name: Joint Academy
Active Comparator: The BOA program
Face-to-face osteoarthritis treatment
 Behavioral: Face-to-face osteoarthritis treatment
3 months face-to-face program
Other Name: The BOA program


Outcome Measures
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Primary Outcome Measures :
  1. Physical functioning [ Time Frame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up ]
    Measured using the 30 second chair stand test, defined in number of repetitions. The result is directly reported after test performance


Secondary Outcome Measures :
  1. NRS pain [ Time Frame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up ]
    Self-reported knee pain on a 0-10 numeric rating scale (NRS) reported as during the latest week

  2. Health-related quality of life [ Time Frame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up ]
    Measured using the EQ5D-5L, index value. Measures the patients status at the day of reporting

  3. Self-reported function [ Time Frame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up ]
    Measured using the KOOS-ps, for the latest week.

  4. Physical activity [ Time Frame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up ]
    Number of minutes of physical activity and exercise per week.


Eligibility Criteria
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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:

I: A clinical diagnosis of knee OA according to American College of Rheumatology (ACR) diagnostic criteria as well as national and international guidelines: knee pain and 3 of the following: > 50 years of age, morning stiffness >30 min, crepitus, bony tenderness, bony enlargement, no palpable warmth; II: Reported knee pain ≥4 and ≤8 on the NRS, and ≥6 to ≤16 in number of repetitions of the 30 second chair stand test, at pre-randomization screening.

II: Able to handle a software program via phone, tablet or computer. III: Able to read and write the Swedish language.

Exclusion criteria:

I: Neurological disease, inflammatory joint disease or cancer. II: Cognitive disorder, e.g. dementia. III: Exercise is contra-indicated for the patient

Contacts and Locations
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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): NCT03328741


Locations
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Sweden
Abels Rehab
Malmö, Sweden
Sponsors and Collaborators
Lund University
Investigators
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Principal Investigator: Håkan Nero, PhD Department of Orthopaedics, Lund University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03328741    
Other Study ID Numbers: OA-treatment RCT
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD for primary and secondary outcomes will be made available upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Study protocol, SAP and ICF will be made available six months after study completion. CSR and Analytic Code will be available after publication of results.
Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

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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 Lund University:
Clinical Trials, Randomized
Telemedicine
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases