Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT02892058
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:
NCT02892058
Study Brief:
Protocol Section:
NCT02892058