Osteoarthritis, KneeNCT03328741
Evaluation of a Web-based Platform for Osteoarthritis Treatment
A study testing Online Osteoarthritis treatment and Face-to-face osteoarthritis treatment in people with Osteoarthritis, Knee, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Online Osteoarthritis treatment and Face-to-face osteoarthritis treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSweden
- Study dates
- 22 May 2018to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- I: Neurological disease, inflammatory joint disease or cancer. II: Cognitive disorder, e.g. dementia. III: Exercise is contra-indicated for the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Online Osteoarthritis treatment, Face-to-face osteoarthritis treatment
- Keywords
- Clinical Trials, Randomized, Telemedicine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Osteoarthritis treatmentBehavioural
Also called Joint Academy
6 week online-program
Face-to-face osteoarthritis treatmentBehavioural
Also called The BOA program
3 months face-to-face program
| Study group | Role | What they receive |
|---|---|---|
| Joint Academy | Experimental | Online osteoarthritis treatment Receives: Behavioral: Online Osteoarthritis treatment |
| The BOA program | Active comparator | Face-to-face osteoarthritis treatment Receives: Behavioral: Face-to-face osteoarthritis treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical functioning
Measured using the 30 second chair stand test, defined in number of repetitions. The result is directly reported after test performance
Measured: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Secondary outcomes (4)
NRS pain
Self-reported knee pain on a 0-10 numeric rating scale (NRS) reported as during the latest week
Measured: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Health-related quality of life
Measured using the EQ5D-5L, index value. Measures the patients status at the day of reporting
Measured: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Self-reported function
Measured using the KOOS-ps, for the latest week.
Measured: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Physical activity
Number of minutes of physical activity and exercise per week.
Measured: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start22 May 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Håkan Nero, PhD, Principal investigator, Department of Orthopaedics, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328741
- Sponsor's protocol ID
- OA-treatment RCT
- Status last verified
- Apr 2022
- First submitted
- 22 Sep 2017
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD for primary and secondary outcomes will be made available upon request.
Publications
Nero H, Ranstam J, Kiadaliri AA, Dahlberg LE. Evaluation of a digital platform for osteoarthritis treatment: study protocol for a randomised clinical study. BMJ Open. 2018 Nov 8;8(11):e022925. doi: 10.1136/bmjopen-2018-022925.
PubMed 30413507
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Web-based Platform for Osteoarthritis Treatment - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03328741
- Acronym / sponsor ID
- OA-treatment RCT
- Conditions
- Osteoarthritis, Knee
- Keywords
- Clinical Trials, Randomized, Telemedicine
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Joint Academy | Experimental | Behavioral: Online Osteoarthritis treatmentOnline osteoarthritis treatment |
| The BOA program | Active comparator | Behavioral: Face-to-face osteoarthritis treatmentFace-to-face osteoarthritis treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- I: Neurological disease, inflammatory joint disease or cancer. II: Cognitive disorder, e.g. dementia. III: Exercise is contra-indicated for the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Osteoarthritis treatmentAlso: Joint Academy6 week online-program | Behavioural | Joint Academy |
| Face-to-face osteoarthritis treatmentAlso: The BOA program3 months face-to-face program | Behavioural | The BOA program |
Primary outcome
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
4 secondary outcomes
NRS pain
Time frame: 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
Self-reported function
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Derived from this study: PubMed 30413507Nero H, Ranstam J, Kiadaliri AA, Dahlberg LE. Evaluation of a digital platform for osteoarthritis treatment: study protocol for a randomised clinical study. BMJ Open. 2018 Nov 8;8(11):e022925. doi: 10.1136/bmjopen-2018-022925.
- Individual participant dataSharing planned: Yes. De-identified IPD for primary and secondary outcomes will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Håkan Nero, PhD principal investigator
Department of Orthopaedics, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Osteoarthritis treatment and Face-to-face osteoarthritis treatment in people with Osteoarthritis, Knee, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical functioning (time frame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03328741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.