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Evaluation of a Web-based Platform for Osteoarthritis Treatment

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ClinicalTrials.gov Identifier: NCT03328741
Recruitment Status : Enrolling by invitation
First Posted : November 1, 2017
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Lund University

Tracking Information
First Submitted Date  ICMJE September 22, 2017
First Posted Date  ICMJE November 1, 2017
Last Update Posted Date August 15, 2019
Actual Study Start Date  ICMJE May 22, 2018
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
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 History Complete list of historical versions of study NCT03328741 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
  • 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
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
  • 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
  • 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
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Web-based Platform for Osteoarthritis Treatment
Official Title  ICMJE Evaluation of a Web-based Platform for Osteoarthritis Treatment - a Randomized Clinical Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Behavioral: Online Osteoarthritis treatment
    6 week online-program
    Other Name: Joint Academy
  • Behavioral: Face-to-face osteoarthritis treatment
    3 months face-to-face program
    Other Name: The BOA program
Study Arms  ICMJE
  • Experimental: Joint Academy
    Online osteoarthritis treatment
    Intervention: Behavioral: Online Osteoarthritis treatment
  • Active Comparator: The BOA program
    Face-to-face osteoarthritis treatment
    Intervention: Behavioral: Face-to-face osteoarthritis treatment
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: March 13, 2018)
270
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2017)
1600
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03328741
Other Study ID Numbers  ICMJE OA-treatment RCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Responsible Party Lund University
Study Sponsor  ICMJE Lund University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Håkan Nero, PhD Department of Orthopaedics, Lund University
PRS Account Lund University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP