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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 January 2013 |
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Main ID: |
NCT01130740 |
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Date of registration:
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24/05/2010 |
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Primary sponsor: |
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Public title:
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Patient and Provider Interventions for Managing Osteoarthritis in Primary Care
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Scientific title:
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Patient and Provider Interventions for Managing Osteoarthritis in Primary Care |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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300 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01130740 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research
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Countries of recruitment
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United States
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Contacts
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Name:
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Kelli Dominick Allen, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Durham VA Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- radiographic evidence of hip OA and / or radiographic of or meets clinical criteria
for knee OA
- current joint symptoms
- BMI >=25
- physically inactive
Exclusion Criteria:
- Diagnosis of rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease
- Hospitalized for a stroke, myocardial infarction or coronary artery revascularization
in the past 3 months
- Active diagnosis of psychosis or serious personality disorder
- On waiting list for / planning arthroplasty
- Severely impaired hearing or speech (patients must be able to respond to phone calls)
- Unable to speak English
- No access to a telephone
- Participating in another OA intervention or other lifestyle change study
- Dementia or other memory loss condition
- Current, uncontrolled substance abuse disorder
- Motor neuron diseases, Parkinson's Disease, multiple sclerosis
- Quadriplegic or paraplegic
- Serious / terminal illness as indicated by referral to hospice or palliative care
- Other self-reported health problem that would prohibit participation in the study
- Nursing home resident
- Other health conditions or personal issues judged by a study team member or primary
care physician to make the patient inappropriate for the study
- Female participants: pregnant or planning to become pregnant
- Metastatic Cancer
- History of gout in knee or hip
- Total joint replacement (knee or hip) surgery, other knee or hip surgery, meniscus
tear (verified by MRI), or ACL tear in the past 6 months
- Have not seen their VA-assigned primary health care provider for more than a year
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Intervention(s)
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Behavioral: Osteoarthritis Intervention
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Primary Outcome(s)
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Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)
[Time Frame: 12-months]
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Secondary Outcome(s)
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PHQ-8
[Time Frame: 12-months]
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Short Physical Performance Test Protocol
[Time Frame: 12-months]
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Secondary ID(s)
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IIR 10-126
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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