OsteoarthritisCOMUTARNCT02879890
Comorbidities and Indirect Health State Utility in Hip and Knee Osteoarthritis
An observational study of Osteoarthritis, run by Central Hospital, Nancy, France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis
- How many people
- 878 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population-based
Who may be able to join
- 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
Who cannot join
- Hip or knee prothesis
- Antecedent of osteotomy
- Severe comorbidity
- Adult under legal protection
About this study
Official title: Impact of Comorbidities on Measure of Indirect Utility Change in Hip and Knee Ostearthritis
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).
Read the detailed description
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
- Conditions
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health utility state
Change in health state utility score between the inclusion in the KHOALA cohort and 5 years later (T5-T0)
Measured: Five years
Secondary outcomes (1)
Minimal Clinically Important Difference (MCID) of health utility state
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startMar 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 878 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUILLEMIN Francis, MD, Central Hospital, Nancy, France
- Investigators
- Francis GUILLEMIN, MD, PhD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879890
- Sponsor's protocol ID
- Comutar1
- Acronym
- COMUTAR
- Status last verified
- Aug 2016
- First submitted
- 23 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Open to partnership
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Comorbidities on Measure of Indirect Utility Change in Hip and Knee Ostearthritis
- ClinicalTrials.gov ID
- NCT02879890
- Acronym / sponsor ID
- COMUTAR / Comutar1
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 878 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population-based
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Hip or knee prothesis
- Antecedent of osteotomy
- Severe comorbidity
- Adult under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Minimal Clinically Important Difference (MCID) of health utility state
Time frame: Five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Individual participant dataSharing planned: Yes. Open to partnership
Related trials for Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis GUILLEMIN, MD, PhD principal investigator
CHRU Nancy
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health utility state (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2016.