Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-26 @ 7:18 PM
Study NCT ID:
NCT02892058
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2016-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-assessment of Flare in Osteoarthritis of Lower Limbs
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Development of a Tool for the Self-assessment of Flare in Patients With Osteoarthritis of Lower Limbs
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLARE-OA
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: