Pharmacist-initiated Intervention Trial in OsteoArthritis (PhIT-OA)
|ClinicalTrials.gov Identifier: NCT00391859|
Recruitment Status : Completed
First Posted : October 25, 2006
Last Update Posted : March 17, 2014
Osteoarthritis (OA) is a major public health concern. Currently, there are at least 3 million Canadians afflicted with this condition with a 50% increase predicted by 2020. It is estimated that 85% of Canadians are afflicted with OA by age 70. As such, using the current health care structure, it is doubtful that the health system can keep pace with this increasing demand. Alternative health care delivery strategies must be investigated.
The purpose of this study is to assess if a pharmacist-initiated intervention for individuals with knee pain with a high likelihood of knee OA will lead to an improvement in the quality of care for these individuals.
We are hopeful that results of this study will show better management of knee osteoarthritis by a pharmacist-initiated intervention (which means that it is the pharmacist who will start the process for an intervention that includes exercise and an educational program when compared to no intervention. If this is the case, by implementing the proposed intervention program, subjects could be diagnosed earlier, the burden of illness on individuals could be diminished through an appropriate intervention program, and economic savings could be embraced.
Hypothesis: Community pharmacists can identify patients with likely knee OA and initiate a multidisciplinary intervention that will improve quality of care and outcomes.
|Condition or disease||Intervention/treatment|
|Knee Osteoarthritis||Procedure: Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA)|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacist-initiated Intervention Trial in OsteoArthritis (PhIT-OA)|
|Study Start Date :||September 2006|
|Primary Completion Date :||June 2010|
|Study Completion Date :||June 2010|
Experimental: Health service provision
Health service provision within the first few months of diagnosis which includes physical examination, radiographs, education, exercise, weight loss, assistive devices and pharmacologic therapy.
Procedure: Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA)
See Detailed Description.
- The primary outcome will be the difference in proportion of patients who receive ≥ 5 of the Arthritis Foundation's quality indicators during the six months of the study. [ Time Frame: 6 months ]
- (Baseline, months 2 and 6 ) [ Time Frame: Months 2 and 6 ]
- There are four secondary outcome measures that will be compared between intervention and usual care subjects at baseline, months 2 and 6: [ Time Frame: Months 2 and 6 ]
- The difference in change of physical functioning (using the mean score from 17 questions from the WOMAC that are directed towards this construct) between intervention and usual care. This outcome has been used in recent, well-designed trials of OA.
- The difference in knee pain (as assessed by five questions on the WOMAC);
- The difference in Health Utilities Index Mark 3 (HUI3); and
- The direct medical resource utilization using a questionnaire validated for use in musculoskeletal diseases.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391859
|Canada, British Columbia|
|Mary Pack Arthritis Center|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Carlo Marra, Ph.D||University of British Columbia|