OsteoarthritisNCT00105677
Understanding the Differences in the Management of Patients With Arthritis of the Knee or Hip
An observational study of Osteoarthritis and Arthritis, Degenerative, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to examine cultural and clinical context factors in African-American and white veterans with knee or hip osteoarthritis with a focus on how these factors may be potentially modifiable determinants of willingness to consider joint replacement. Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Osteoarthritis, Arthritis, Degenerative, Osteoarthritis, Hip
- How many people
- 980 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Sep 2006
- 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 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic, frequent knee or hip pain based on the National Health And Nutrition Examination Survey
- Age >50 and <80 (at least 50 but not to exceed 79 years of age)
- Severe or extreme knee or hip OA on the Western Ontario and McMaster Universities Osteoarthritis Index (i.e., score greater than or equal to 39)
Who cannot join
- Prior history of knee or hip joint replacement
- Terminal illness (i.e., end-stage cancer, CHF, COPD, etc.)
- Physician-diagnosed inflammatory arthritis
- Dementia
- Prosthetic leg
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Arizona, 15240
About this study
Official title: Reasons for Disparities in Joint Replacement Utilization
The purpose of this study is to examine cultural and clinical context factors in African-American and white veterans with knee or hip osteoarthritis with a focus on how these factors may be potentially modifiable determinants of willingness to consider joint replacement.
Read the detailed description
The study focuses on identifying potentially modifiable determinants of patients� willingness to consider joint replacement as a treatment option for osteoarthritis of the knee or hip. This line of research is informed by not only our prior work but also recent studies on health disparities and patient decision-making. Our long-term goal is the development and evaluation of interventions to target these determinants of willingness in order to eliminate ethnic disparities in joint replacement. The study findings will assist in laying the groundwork for the design of such interventions for patients with osteoarthritis.
- Keywords
- Racial/ethnic health disparities, Attitudes, Osteoarthritis Management, Patient Perceptions
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Hip, Osteoarthritis, Knee, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2005 (estimated)
- Study startAug 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- Enrolment
- 980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- C. Kent Kwoh, MD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105677
- Sponsor's protocol ID
- ECV 03-201
- Status last verified
- Oct 2006
- First submitted
- 16 Mar 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones AC, Kwoh CK, Groeneveld PW, Mor M, Geng M, Ibrahim SA. Investigating racial differences in coping with chronic osteoarthritis pain. J Cross Cult Gerontol. 2008 Dec;23(4):339-47. doi: 10.1007/s10823-008-9071-9.
PubMed 18561011Emejuaiwe N, Jones AC, Ibrahim SA, Kwoh CK. Disparities in joint replacement utilization: a quality of care issue. Clin Exp Rheumatol. 2007 Nov-Dec;25(6 Suppl 47):44-9.
PubMed 18021506Groeneveld PW, Kwoh CK, Mor MK, Appelt CJ, Geng M, Gutierrez JC, Wessel DS, Ibrahim SA. Racial differences in expectations of joint replacement surgery outcomes. Arthritis Rheum. 2008 May 15;59(5):730-7. doi: 10.1002/art.23565.
PubMed 18438917
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reasons for Disparities in Joint Replacement Utilization
- ClinicalTrials.gov ID
- NCT00105677
- Acronym / sponsor ID
- ECV 03-201
- Keywords
- Racial/ethnic health disparities, Attitudes, Osteoarthritis Management, Patient Perceptions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 980 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of Pittsburgh
- Study start
- Aug 2004
- Study completion
- Sep 2006 (actual)
- First posted
- 17 Mar 2005 (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.
The purpose of this study is to examine cultural and clinical context factors in African-American and white veterans with knee or hip osteoarthritis with a focus on how these factors may be potentially modifiable determinants of willingness to consider joint replacement.
Detailed description
The study focuses on identifying potentially modifiable determinants of patients� willingness to consider joint replacement as a treatment option for osteoarthritis of the knee or hip. This line of research is informed by not only our prior work but also recent studies on health disparities and patient decision-making. Our long-term goal is the development and evaluation of interventions to target these determinants of willingness in order to eliminate ethnic disparities in joint replacement. The study findings will assist in laying the groundwork for the design of such interventions for patients with osteoarthritis.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic, frequent knee or hip pain based on the National Health And Nutrition Examination Survey
- Age >50 and <80 (at least 50 but not to exceed 79 years of age)
- Severe or extreme knee or hip OA on the Western Ontario and McMaster Universities Osteoarthritis Index (i.e., score greater than or equal to 39)
Key exclusion criteria (5 listed)
- Prior history of knee or hip joint replacement
- Terminal illness (i.e., end-stage cancer, CHF, COPD, etc.)
- Physician-diagnosed inflammatory arthritis
- Dementia
- Prosthetic leg
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
Not reported in the source record.
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 7 Apr 2015.
- Results publication: PubMed 18561011Jones AC, Kwoh CK, Groeneveld PW, Mor M, Geng M, Ibrahim SA. Investigating racial differences in coping with chronic osteoarthritis pain. J Cross Cult Gerontol. 2008 Dec;23(4):339-47. doi: 10.1007/s10823-008-9071-9.
- Results publication: PubMed 18021506Emejuaiwe N, Jones AC, Ibrahim SA, Kwoh CK. Disparities in joint replacement utilization: a quality of care issue. Clin Exp Rheumatol. 2007 Nov-Dec;25(6 Suppl 47):44-9.
- Results publication: PubMed 18438917Groeneveld PW, Kwoh CK, Mor MK, Appelt CJ, Geng M, Gutierrez JC, Wessel DS, Ibrahim SA. Racial differences in expectations of joint replacement surgery outcomes. Arthritis Rheum. 2008 May 15;59(5):730-7. doi: 10.1002/art.23565.
- Click here for more information about this study: Reasons for Disparities in Joint Replacement UtilizationLink provided by the sponsor.
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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.
C. Kent Kwoh, MD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Arthritis, Degenerative, run by US Department of Veterans Affairs at 1 site in United States.
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 3 inclusion and 5 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00105677, which also lists 3 linked publications.
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 7 Apr 2015.