Evaluation of a Web-based Platform for Osteoarthritis Treatment

April 19, 2022 updated by: Lund University

Evaluation of a Web-based Platform for Osteoarthritis Treatment - a Randomized Clinical Trial

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden
        • Abels Rehab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Joint Academy
Online osteoarthritis treatment
Behavioral: Online Osteoarthritis treatment
6 week online-program
Other Names:
  • 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 Names:
  • The BOA program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
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
Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
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.
Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
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.
Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Investigators

  • Principal Investigator: Håkan Nero, PhD, Department of Orthopaedics, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2018

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 22, 2017

First Submitted That Met QC Criteria

October 27, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OA-treatment RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified IPD for primary and secondary outcomes will be made available upon request.

IPD Sharing 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.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis, Knee

Clinical Trials on Online Osteoarthritis treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe