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Completed

NCT Number: NCT02879890

Comorbidities and Indirect Health State Utility in Hip and Knee Osteoarthritis

National cohort study aimed to investigate the impact of comorbidities (number and type of comorbidities) on health utility state change in lower lim osteoarthritis (hip and knee OA).

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

The concept of health utility state was developed by economists to explain individual choices and preferences for health states. It is expressed as the "desirability or preference that individuals exhibit for the condition". This health utility state can be measured indirectly using health-relation quality of life questionnaires.

Chronic diseases such as OA are known to be associated with impairment of quality of life. Given that OA prevalence increases with age, OA is often associated with other diseases (comorbidities). A cross-sectional study showed that comorbidities are associated with lower health utility state in OA. Investigation of longitudinal impact of comorbidities on health utility state change is need.

Main objective: Determine the impact of comorbidities on change in health utility state among patients with lower limb OA.

Secondary objective: Determine the Minimal Clinically important Difference in health utility state among patients with lower limb OA.

The COMUTAR study uses longitudinal data from the Knee and Hip Osteoarthritis Longitudinal Assessment (KHOALA) cohort study. Health utility state is measured indirectly using Medical Outcome Study Short Form-36 quality of life questionnaire Comorbidities are assessed using the Functional Comorbidity Index

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age: 40-75 years
  • Uni or bilateral lower limb osteoarthritis (OA) according to the American College of Rheumatology (ACR) and European league against rheumatism (EULAR) criteria

Exclusion criteria

  • Hip or knee prothesis
  • Antecedent of osteotomy
  • Severe comorbidity
  • Adult under legal protection

Treatment and study plan

Primary outcomes

  1. Change in health utility state

    Time frame: Five years

    Change in health state utility score between the inclusion in the KHOALA cohort and 5 years later (T5-T0)

Secondary outcomes

  1. Minimal Clinically Important Difference (MCID) of health utility state

    Time frame: Five years

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Impact of Comorbidities on Measure of Indirect Utility Change in Hip and Knee Ostearthritis

Acronym: COMUTAR

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Aug 26, 2016
Registry last updated
Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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