NCT03328741

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

May 22, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

4.5 years

First QC Date

September 22, 2017

Last Update Submit

April 19, 2022

Conditions

Osteoarthritis, Knee

Keywords

Clinical Trials, RandomizedTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Physical functioning

    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 Outcomes (4)

  • NRS pain

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

  • Health-related quality of life

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

  • Self-reported function

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

  • Physical activity

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

Study Arms (2)

Joint Academy

EXPERIMENTAL

Online osteoarthritis treatment

Behavioral: Online Osteoarthritis treatment

The BOA program

ACTIVE COMPARATOR

Face-to-face osteoarthritis treatment

Behavioral: Face-to-face osteoarthritis treatment

Interventions

Online Osteoarthritis treatmentBEHAVIORAL

6 week online-program

Also known as: Joint Academy
Joint Academy
Face-to-face osteoarthritis treatmentBEHAVIORAL

3 months face-to-face program

Also known as: The BOA program
The BOA program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • I: Neurological disease, inflammatory joint disease or cancer. II: Cognitive disorder, e.g. dementia. III: Exercise is contra-indicated for the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abels Rehab

Malmo, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 30413507DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Håkan Nero, PhD

    Department of Orthopaedics, Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2017

First Posted

November 1, 2017

Study Start

May 22, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

SE(1)