Knee Osteoarthritis Clinical Trial
— ACTIONOfficial title:
Behavioral & Social Science Research on Understanding and Reducing Health Disparities
NCT number | NCT01851785 |
Other study ID # | 5R01AR059615-03 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2010 |
Est. completion date | July 8, 2019 |
Verified date | September 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized, controlled design will be utilized to examine and compare the effectiveness of
the proposed educational intervention, which includes an educational decision aid with
attention control on select key patient-centered and process of care outcomes. The study
sample will consist of approximately 300 African-American patients with osteoarthritis (OA)
of the knee. Patients will be recruited from Pennsylvania Presbyterian Medical Center and the
Philadelphia VA Medical Center and will be randomized to one of the two study arms.
The immediate goal of this randomized controlled trial is to assess the effect of a
high-quality, evidence-based, patient-centered educational intervention on African American
patient preferences, expectations, and the likelihood of receiving a recommendation for knee
joint replacement surgery when clinically indicated. The long-term goal of this research is
to implement effective strategies to improve minority patients' access to joint replacement
and ultimately eliminate racial disparities in the utilization of this effective treatment
for knee OA.
Study Aim: To examine the effect of the decision aid (DA) intervention on the likelihood of
receiving a recommendation for knee joint replacement when clinically indicated. Hypothesis:
The DA intervention will lead to higher rate of treatment recommendation within 6 months.
Secondary Aim: To examine the effect of the DA intervention on the rate of knee replacement
receipt within 12 months. Hypothesis: Patients randomized to receive the intervention will
undergo knee replacement within 12 months at a higher rate than those in the attention
control group.
Status | Completed |
Enrollment | 340 |
Est. completion date | July 8, 2019 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - African-American patient referred to orthopedic doctor - Age 50 or older - Presence of knee OA by American College of Rheumatology as evidenced by: - Chronic, frequent knee pain based on the NHANES questions. - Moderate to severe knee OA based on WOMAC index score 39. - Radiographic evidence of knee OA. Exclusion Criteria: - Prior history of any major joint replacement. - Terminal Illness (e.g. end stage cancer). - Physician diagnosed inflammatory arthritis (i.e., rheumatoid arthritis, connective tissue disease, ankylosing spondylitis, or other seronegative Spondyloarthropathy.) - Contra-indications to replacement surgery (e.g., lower extremity paralysis as result of stroke). - Prosthetic leg - Cognitive impairment (e.g.,dementia) - No home telephone service. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recommendation of knee joint replacement | Recommendation of knee joint replacement 6 months after intervention will be assessed for all patients by chart abstraction. | 6 months after intervention | |
Secondary | Receipt of knee joint replacement | Receipt of knee joint replacement will be assessed for all patients 12 months post-intervention initially through telephone survey and then validated by medical record review. | assessed for all patients 12 months post-intervention |
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