Clinical trial NCT02892058: Self-assessment of Flare in Osteoarthritis of Lower Limbs
Official title: Development of a Tool for the Self-assessment of Flare in Patients With Osteoarthritis of Lower Limbs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 398
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ability of a FLARE-OA self-questionnaire to detect flare episodes in knee or hip osteoarthritis
timeFrame: Baseline
measure: Change in ability of a FLARE-OA self-questionnaire to detect flare episodes in knee or hip osteoarthritis during a 6 months period
timeFrame: At 3 and 6 month follow-up
Secondary outcomes:
measure: Evolution of the quality of life during a 6 months period with the standardized OAKHQOL questionnaire
timeFrame: up to 3 and 6 month
measure: Evolution of the functional limitation related to knee osteoarthritis during a 6 months period with the standardized KOOS questionnaire
timeFrame: up to 3 and 6 month
measure: Evolution of the functional limitation related to hip osteoarthritis during a 6 months period with the standardized HOOS questionnaire
timeFrame: up to 3 and 6 month
measure: Pain intensity measure
timeFrame: up to 3 and 6 month
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Institute of Bone and Joint Research - University of Sydney
city: Toronto
country: Canada
facility: University of Toronto
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Brest
country: France
facility: CHU La Cavale Blanche
city: Dijon
country: France
facility: CHU Hôpital Général
city: Grenoble
country: France
facility: CHU Hôpital Sud A. Michallon
city: Nantes
country: France
facility: CHRU Hôtel Dieu
city: Paris
country: France
facility: AP-HP Saint Antoine
city: Paris
country: France
facility: AP-HP La Pitié
city: Poitiers
country: France
facility: CHU de Poitiers
city: Vandoeuvre-les-Nancy
country: France
facility: CHRU, Rhumatologie
city: Fort-de-France
country: Martinique
facility: CHU Fort de France
Study officials:
affiliation: CHRU NANCY, CIC 1433 Epidémiologie Clinique
name: Francis GUILLEMIN
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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 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.