Determinants of Functional Ability, Perceived Health, and Interaction With Multimorbidity in Hip and Knee Osteoarthritis

NCT02887092 | Completed DMC

• 1 other identifier: PRO-ART
• Study Type: observational
• Target: 881
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hip and knee osteoarthritis (OA) is an important health problem with a high prevalence and significant consequences on functional ability, perceived health, restriction of autonomy and handicap. The weight of multimorbidities and their interaction on functional ability and perceived health are left unexplored. This project will rely on the cohort KHOALA, representative, multiregional, of 881 prevalent cases (symptomatic hip and knee OA). Main objective:

• to describe the evolution over time of pain, functional ability, social participation and quality of life in subjects with hip and knee OA
• to identify prognosis factors of disease evolution (socio-demographic, clinical, and other health parameters)
• to determine interactions with comorbidities, other personal and environmental factors (ICF model). Concurrent objective: to improve measurement of perceived health specific to hip and knee OA by the OAKHQOL by improving its metrologic performances based on item response theory. Task 1: To prepare an improved measurement scale, available as a judgment criteria for the 3rd year of cohort follow up, over the april 2010-march 2012 period, the mini-OAKHQOL Task 2: Evaluation of the cohort in 2010-2012 (year 3 of follow up) in a repeated measure design to best assess the evolution of perceived health and functional ability over time, and to identify stability of deterioration of autonomy. Perspectives: This project targets to provide public health deciders with information of good quality to help them manage determinants of perceived health in OA subjects, as essential factors to health care resource utilization in their various modalities.

Conditions

Osteoarthritis

Keywords

health determinants; epidemiology; maintaining autonomy; psychology; osteoarthritis; perceived health

Outcome Measures

Primary Outcomes (1)

• change in quality of life

  3 years

Secondary Outcomes (3)

• comorbidity

  3 years

• change in functional ability

  3 years

• change in pain

  3 years

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient with hip or knee osteoarthritis

You may qualify if:

• hip or knee osteoarthritis (tibiofemoral), uni or bilateral, symptomatic, with confirmed diagnosis according to American College of Rheumatology ACR and European League Against Rheumatism (EULAR)
• Kellgren and Laurence radiological stage at least 2

You may not qualify if:

• knee or hip prosthesis on painful joint
• preceding osteotomy
• serious comorbidity (affecting quality of life, or leading to a high care consumption)
• according to X-ray : knee pain with isolated patello-femoral osteoarthritis (i.e without an associated tibiofemoral osteoarthritis)
• other pathology on knee or hip
• adults getting a legal protection or with the incapacity to give their consent

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• University of Lorraine: collaborator
• University of Paris 5 - Rene Descartes: collaborator

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Francis Guillemin, MD, PhD

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 1, 2016
• Study Start: April 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2011
• Last Updated: September 1, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share