Self-assessment of Flare in Osteoarthritis of Lower Limbs

NCT02892058 | Completed

• 1 other identifier: FLARE-OA
• Study Type: observational
• Target: 398
• Locations: 4 countries
• Sites: 12

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. 1.define the construct through development of a conceptual framework
2. 2.use the conceptual framework to inform the development of a patient-reported outcome measure, Flare-OA tool, for people with OA
3. 3.evaluate the psychometric properties of the new measure using the OMERACT (Outcome Measures in Rheumatology) filter 2.0 and Rasch measurement methods.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Evolution of the quality of life during a 6 months period with the standardized OAKHQOL questionnaire

  up to 3 and 6 month

• Evolution of the functional limitation related to knee osteoarthritis during a 6 months period with the standardized KOOS questionnaire

  up to 3 and 6 month

• Evolution of the functional limitation related to hip osteoarthritis during a 6 months period with the standardized HOOS questionnaire

  up to 3 and 6 month

• Pain intensity measure

  up to 3 and 6 month

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with knee or hip osteoarthritis (OA). France: several sources will be sollicited including: * investigators in rheumatology and general practitioner network in each participating centre, * Patients participating in the KHOALA cohort, a representative prevalent case cohort study followed-up in 6 centres. Australia: patients participating in the online cohort SPARK-web study Canada : patients will be recruited in Toronto osteoarthritis center.

You may qualify if:

• 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.

You may not qualify if:

• Patients who never experienced nor currently report having a flare of OA
• Patients with both hip and knee OA

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (12)

Institute of Bone and Joint Research - University of Sydney

Sydney, Australia

Location

University of Toronto

Toronto, Canada

Location

CHU Jean Minjoz

Besançon, 25030, France

Location

CHU La Cavale Blanche

Brest, 29607, France

Location

CHU Hôpital Général

Dijon, 21033, France

Location

CHU Hôpital Sud A. Michallon

Grenoble, 38043, France

Location

CHRU Hôtel Dieu

Nantes, 44093, France

Location

AP-HP Saint Antoine

Paris, 75571, France

Location

AP-HP La Pitié

Paris, 75651, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CHRU, Rhumatologie

Vandœuvre-lès-Nancy, 54511, France

Location

CHU Fort de France

Fort-de-France, 97261, Martinique

Location

Related Publications (3)

• 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.

  PMID: 33775461 BACKGROUND

• 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 in Knee and Hip Osteoarthritis (OA): Consensus Building of the Flare-in-OA OMERACT Group. J Rheumatol. 2019 Sep;46(9):1188-1191. doi: 10.3899/jrheum.181085. Epub 2019 May 15.

  PMID: 31092709 RESULT

• 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 in knee and hip osteoarthritis. Osteoarthritis Cartilage. 2022 May;30(5):689-696. doi: 10.1016/j.joca.2021.12.011. Epub 2022 Jan 20.

  PMID: 35066175 RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Francis GUILLEMIN

  CHRU NANCY, CIC 1433 Epidémiologie Clinique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 8, 2016
• Study Start: April 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9); CA (1); MA (1); AU (1)