The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02892058




Registration number
NCT02892058
Ethics application status
Date submitted
23/08/2016
Date registered
8/09/2016
Date last updated
17/03/2020

Titles & IDs
Public title
Self-assessment of Flare in Osteoarthritis of Lower Limbs
Scientific title
Development of a Tool for the Self-assessment of Flare in Patients With Osteoarthritis of Lower Limbs
Secondary ID [1] 0 0
FLARE-OA
Universal Trial Number (UTN)
Trial acronym
FLARE-OA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ability of a FLARE-OA self-questionnaire to detect flare episodes in knee or hip osteoarthritis - patient-reported outcome questionnaire for the self-assessment of flare in osteoarthritis. The questionnaire will be developed during the first part of the study.
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Change in ability of a FLARE-OA self-questionnaire to detect flare episodes in knee or hip osteoarthritis during a 6 months period - patient-reported outcome questionnaire for the self-assessment of flare in osteoarthritis. The questionnaire will be developed during the first part of the study.
Timepoint [2] 0 0
At 3 and 6 month follow-up
Secondary outcome [1] 0 0
Evolution of the quality of life during a 6 months period with the standardized OAKHQOL questionnaire - Osteoarthritis knee and hip quality of life questionnaire (OAKHQOL) self-assessment questionnaire
Timepoint [1] 0 0
up to 3 and 6 month
Secondary outcome [2] 0 0
Evolution of the functional limitation related to knee osteoarthritis during a 6 months period with the standardized KOOS questionnaire - Knee injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4.
Timepoint [2] 0 0
up to 3 and 6 month
Secondary outcome [3] 0 0
Evolution of the functional limitation related to hip osteoarthritis during a 6 months period with the standardized HOOS questionnaire - Hip disability and Osteoarthritis Outcome Score (HOOS) patient questionnaire. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4.
Timepoint [3] 0 0
up to 3 and 6 month
Secondary outcome [4] 0 0
Pain intensity measure - Self-reported pain intensity using a numerical rating scale
Timepoint [4] 0 0
up to 3 and 6 month

Eligibility
Key inclusion criteria
- with clinical and radiological hip or knee OA confirmed by a physician,

- whatever their status regarding flare of OA. The intention of the Flare-OA tool is not
to detect current flare only, but also a flare that may have occurred before the
encounter with the health care professional. Therefore patient will not be selected on
flare, and patients with flare will not be excluded.
Minimum age
45 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who never experienced nor currently report having a flare of OA

- Patients with both hip and knee OA

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Institute of Bone and Joint Research - University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Toronto
Country [2] 0 0
France
State/province [2] 0 0
Besançon
Country [3] 0 0
France
State/province [3] 0 0
Brest
Country [4] 0 0
France
State/province [4] 0 0
Dijon
Country [5] 0 0
France
State/province [5] 0 0
Fort De France
Country [6] 0 0
France
State/province [6] 0 0
Grenoble
Country [7] 0 0
France
State/province [7] 0 0
Nantes
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
France
State/province [9] 0 0
Poitiers
Country [10] 0 0
France
State/province [10] 0 0
Vandoeuvre-les-Nancy

Funding & Sponsors
Primary sponsor type
Other
Name
Central Hospital, Nancy, France
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The need for a tool to measure flare in lower limb osteoarthritis (OA of the hip and knee) is
justified by the opportunities for development of clinical trials targeting hip and knee OA
long-term treatment (slow acting drug, disease modifying drug) and short-term treatment of
symptoms. Such treatments are currently under development and will likely bring important
changes in the treatment of patients. The development of a Flare-OA tool would be essential
to capture the occurrence of flare, and to implement and adapt treatment strategies.

This project was elaborated with the aims to:

1. define the construct through development of a conceptual framework

2. use the conceptual framework to inform the development of a patient-reported outcome
measure, Flare-OA tool, for people with OA

3. evaluate the psychometric properties of the new measure using the OMERACT (Outcome
Measures in Rheumatology) filter 2.0 and Rasch measurement methods.
Trial website
https://clinicaltrials.gov/show/NCT02892058
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Francis GUILLEMIN
Address 0 0
CHRU NANCY, CIC 1433 Epidémiologie Clinique
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02892058