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OsteoarthritisFLARE-OANCT02892058

Self-assessment of Flare in Osteoarthritis of Lower Limbs

An observational study of Osteoarthritis, run by Central Hospital, Nancy, France at 12 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Osteoarthritis
How many people
398 participants
Where
12 sitesin 4 countries
Study dates
Apr 2015to Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

12 sites in 4 countries.

12 sites in 4 countries

France9 sites

  • CHU Jean Minjoz

    Besançon, 25030

  • CHU La Cavale Blanche

    Brest, 29607

  • CHU Hôpital Général

    Dijon, 21033

  • CHU Hôpital Sud A. Michallon

    Grenoble, 38043

  • CHRU Hôtel Dieu

    Nantes, 44093

  • AP-HP Saint Antoine

    Paris, 75571

  • AP-HP La Pitié

    Paris, 75651

  • CHU de Poitiers

    Poitiers, 86021

  • CHRU, Rhumatologie

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Australia1 site

  • Institute of Bone and Joint Research - University of Sydney

    Sydney

Other trials in Australia

Canada1 site

  • University of Toronto

    Toronto

Other trials in Canada

Martinique1 site

  • CHU Fort de France

    Fort-de-France, 97261

Other trials in Martinique

About this study

Official title: Development of a Tool for the Self-assessment of Flare in Patients With Osteoarthritis of Lower Limbs

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.
Read the 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.
Conditions
Osteoarthritis
Medical subject headings
Osteoarthritis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: At 3 and 6 month follow-up

Secondary outcomes (4)

  1. 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

    Measured: up to 3 and 6 month

  2. 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.

    Measured: up to 3 and 6 month

  3. 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.

    Measured: up to 3 and 6 month

  4. Pain intensity measure

    Self-reported pain intensity using a numerical rating scale

    Measured: up to 3 and 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2016 (estimated)
  2. Study startApr 2015
  3. Primary completionDec 2022
  4. Study completionDec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
398 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02892058
Sponsor's protocol ID
FLARE-OA
Acronym
FLARE-OA
Status last verified
Feb 2023
First submitted
23 Aug 2016
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33775461

  • 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.

    PubMed 31092709

  • 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.

    PubMed 35066175

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, run by Central Hospital, Nancy, France at 12 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France, Australia, Canada, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ability of a FLARE-OA self-questionnaire to detect flare episodes in knee or hip osteoarthritis (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02892058, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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