Osteoarthritis Clinical Trial
— FLARE-OAOfficial title:
Development of a Tool for the Self-assessment of Flare in Patients With Osteoarthritis of Lower Limbs
NCT number | NCT02892058 |
Other study ID # | FLARE-OA |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | December 2022 |
Verified date | February 2023 |
Source | Central Hospital, Nancy, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 398 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility | 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. Exclusion Criteria: - Patients who never experienced nor currently report having a flare of OA - Patients with both hip and knee OA |
Country | Name | City | State |
---|---|---|---|
Australia | Institute of Bone and Joint Research - University of Sydney | Sydney | |
Canada | University of Toronto | Toronto | |
France | CHU Jean Minjoz | Besançon | |
France | CHU La Cavale Blanche | Brest | |
France | CHU Hôpital Général | Dijon | |
France | CHU Hôpital Sud A. Michallon | Grenoble | |
France | CHRU Hôtel Dieu | Nantes | |
France | AP-HP La Pitié | Paris | |
France | AP-HP Saint Antoine | Paris | |
France | CHU de Poitiers | Poitiers | |
France | CHRU, Rhumatologie | Vandoeuvre-les-Nancy | |
Martinique | CHU Fort de France | Fort-de-France |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
Australia, Canada, France, Martinique,
Guillemin F, Ricatte C, Barcenilla-Wong A, Schoumacker A, Cross M, Alleyrat C, Buttel T, Cembalo M, Manseur H, Urban H, Fautrel B, Conaghan PG, Hawker G, Rutherford C, March L, Spitz E, Hunter DJ. Developing a Preliminary Definition and Domains of Flare i — View Citation
King LK, Epstein J, Cross M, Buzzi M, Buttel T, Cembalo SM, Spitz E, Adams CL, Adebajo A, Bennell K, Blanco B, Courage U, Decary S, Gill M, Gill TK, Hajji R, Hinman RS, Jones A, Li LC, Mather K, Mani R, Nasef SI, Oo WM, Osteras N, Otobo TM, Ramiro S, Sharma S, April KT, Touma Z, Whittaker JL, Wluka AE, Grosskleg S, Hunter DJ, Shea B, Hawker GA, Callahan LF, March L, Guillemin F. Endorsement of the domains of knee and hip osteoarthritis (OA) flare: A report from the OMERACT 2020 inaugural virtual consensus vote from the flares in OA working group. Semin Arthritis Rheum. 2021 Jun;51(3):618-622. doi: 10.1016/j.semarthrit.2021.03.010. Epub 2021 Mar 20. — View Citation
Traore Y, Epstein J, Spitz E, March L, Maillefert JF, Rutherford C, Ricatte C, Alleyrat C, Cross M, King LK, Callahan LF, Fautrel B, Buttel T, Hawker G, Hunter DJ, Guillemin F. Development and validation of the Flare-OA questionnaire for measuring flare i — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline | |
Primary | 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. | At 3 and 6 month follow-up | |
Secondary | 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 | up to 3 and 6 month | |
Secondary | 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. | up to 3 and 6 month | |
Secondary | 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. | up to 3 and 6 month | |
Secondary | Pain intensity measure | Self-reported pain intensity using a numerical rating scale | up to 3 and 6 month |
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