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Evaluation of a Web-based Platform for Osteoarthritis Treatment

Primary Purpose

Osteoarthritis, Knee

Status
Suspended
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Online Osteoarthritis treatment
Face-to-face osteoarthritis treatment
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Clinical Trials, Randomized, Telemedicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abels Rehab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Joint Academy

The BOA program

Arm Description

Online osteoarthritis treatment

Face-to-face osteoarthritis treatment

Outcomes

Primary Outcome Measures

Physical functioning
Measured using the 30 second chair stand test, defined in number of repetitions. The result is directly reported after test performance

Secondary Outcome Measures

NRS pain
Self-reported knee pain on a 0-10 numeric rating scale (NRS) reported as during the latest week
Health-related quality of life
Measured using the EQ5D-5L, index value. Measures the patients status at the day of reporting
Self-reported function
Measured using the KOOS-ps, for the latest week.
Physical activity
Number of minutes of physical activity and exercise per week.

Full Information

First Posted
September 22, 2017
Last Updated
April 19, 2022
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT03328741
Brief Title
Evaluation of a Web-based Platform for Osteoarthritis Treatment
Official Title
Evaluation of a Web-based Platform for Osteoarthritis Treatment - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Suspended
Why Stopped
COVID-19
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Clinical Trials, Randomized, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Joint Academy
Arm Type
Experimental
Arm Description
Online osteoarthritis treatment
Arm Title
The BOA program
Arm Type
Active Comparator
Arm Description
Face-to-face osteoarthritis treatment
Intervention Type
Behavioral
Intervention Name(s)
Online Osteoarthritis treatment
Other Intervention Name(s)
Joint Academy
Intervention Description
6 week online-program
Intervention Type
Behavioral
Intervention Name(s)
Face-to-face osteoarthritis treatment
Other Intervention Name(s)
The BOA program
Intervention Description
3 months face-to-face program
Primary Outcome Measure Information:
Title
Physical functioning
Description
Measured using the 30 second chair stand test, defined in number of repetitions. The result is directly reported after test performance
Time Frame
Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Secondary Outcome Measure Information:
Title
NRS pain
Description
Self-reported knee pain on a 0-10 numeric rating scale (NRS) reported as during the latest week
Time Frame
Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Title
Health-related quality of life
Description
Measured using the EQ5D-5L, index value. Measures the patients status at the day of reporting
Time Frame
Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Title
Self-reported function
Description
Measured using the KOOS-ps, for the latest week.
Time Frame
Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Title
Physical activity
Description
Number of minutes of physical activity and exercise per week.
Time Frame
Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Håkan Nero, PhD
Organizational Affiliation
Department of Orthopaedics, Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abels Rehab
City
Malmö
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
30413507
Citation
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.
Results Reference
derived

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Evaluation of a Web-based Platform for Osteoarthritis Treatment

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