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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lund University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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