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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2023
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Chronologically, the development of a Flare-OA (osteoarthritis) tool will be addressed in the first part of the project (Part 1) and its psychometric validity was evaluated in the second part (Part 2). Part 1 of the project: The development of the Flare-OA tool will be conducted in several steps, and needs multiple proficiencies in qualitative research (health psychologist), in quantitative research (epidemiologist, psychometrician), in experience of the disease (patients), and in experience of care of the disease (health care professionals). Two approaches will be taken to define the construct of a flare in lower limb OA: A review of the literature, and the development of a conceptual framework informed by the results of the literature. To help define/conceptualize the construct "Flare in OA" a procedure will be implemented to identify (what are the key variables, or symptoms, that get worse) and clarify (how exactly these variables are described in the literature, by patients, and by clinicians. Participants : 1. - Patients should be representative of the disease spectrum, i.e. of prevalent cases. They will be recruited in clinical settings and epidemiological sources. 2. - Health care professionals (HCP) will include General Practitioners, Rheumatologists, Rehabilitation specialists, Orthopaedic surgeons, Nurse in general practice or orthopedic wards, Physiotherapists.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Countries where clinical trial is conducted

Australia,  Canada,  France,  Martinique, 

References & Publications (3)

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

Outcome

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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