N/A
N=300
Patient and Provider Interventions for Managing Osteoarthritis in Primary Care
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01130740 ↗Enrolled (actual)
300
Serious AEs
14.3%
Results posted
Jan 2015
Primary outcome: Primary: Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) — 48.4; 48.4; 43.5; 41.2 units on a scale — p=0.158
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Osteoarthritis Intervention (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) |
48.4; 48.4; 43.5; 41.2; 48.5; 44.4 | 0.158 |
| SECONDARY Short Physical Performance Test Protocol |
8.01; 8.01; 7.53; 7.86 | 0.274 |
| SECONDARY PHQ-8 |
6.83; 6.83; 6.83; 6.21 | 0.177 |
Summary
Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of disability among veterans. Many veterans with OA have significant pain and functional limitations, even though they receive some medical care for their OA. Efforts are needed to help veterans to improve OA-related outcomes. This study will examine a comprehensive approach to helping veterans manage their OA-related symptoms, in the context of a VA clinical setting. The study examines an intervention aimed at helping veterans with behaviors that are known to improve OA-related pain and function (such as exercise, weight management, and coping with pain), as well as helping providers to implement evidence-based recommendations for clinical care. The intervention is relatively low cost and easy to disseminate, with the patient component being telephone based. Therefore, if effective, this intervention could be implemented widely across the VA healthcare system.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01130740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.