Self-assessment of Flare in Osteoarthritis of Lower Limbs

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT02892058
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ability of a FLARE-OA self-questionnaire to detect flare episodes in knee or hip osteoarthritis	Baseline	patient-reported outcome questionnaire for the self-assessment of flare in osteoarthritis. The questionnaire will be developed during the first part of the study.
Change in ability of a FLARE-OA self-questionnaire to detect flare episodes in knee or hip osteoarthritis during a 6 months period	At 3 and 6 month follow-up	patient-reported outcome questionnaire for the self-assessment of flare in osteoarthritis. The questionnaire will be developed during the first part of the study.

Secondary Outcome Measures

Name	Time	Method
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	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.
Pain intensity measure	up to 3 and 6 month	Self-reported pain intensity using a numerical rating scale
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	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.
Evolution of the quality of life during a 6 months period with the standardized OAKHQOL questionnaire	up to 3 and 6 month	Osteoarthritis knee and hip quality of life questionnaire (OAKHQOL) self-assessment questionnaire

Trial Locations

Locations (12)

CHU Hôpital Général; 🇫🇷 Dijon, France

CHU Fort de France; 🇲🇶 Fort-de-France, Martinique

AP-HP Saint Antoine; 🇫🇷 Paris, France

University of Toronto; 🇨🇦 Toronto, Canada

CHU de Poitiers; 🇫🇷 Poitiers, France

AP-HP La Pitié; 🇫🇷 Paris, France

CHU Hôpital Sud A. Michallon; 🇫🇷 Grenoble, France

CHRU Hôtel Dieu; 🇫🇷 Nantes, France

CHRU, Rhumatologie; 🇫🇷 Vandoeuvre-les-Nancy, France

CHU La Cavale Blanche; 🇫🇷 Brest, France

Institute of Bone and Joint Research - University of Sydney; 🇦🇺 Sydney, Australia

CHU Jean Minjoz; 🇫🇷 Besançon, France