Knee OsteoarthritisNCT00391859
Pharmacist-initiated Intervention Trial in OsteoArthritis (PhIT-OA)
A study testing Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA) in people with Knee Osteoarthritis, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Jun 2010
- Phase
- Interventional
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >50 years
- ≥ 4 weeks of pain, aching or discomfort in or around the knee
- Overweight or obese defined as BMI defined as ≥ 27 kg/m2
- Not actively participating in a formal exercise program within the past 6 months
- Self-reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking one quarter of a mile, getting in and out of a chair, or going up and down stairs.
- Meet eligibility using the criteria on the pharmacist screening form (see attachment) - This form was adapted from the PhIND-OA study and amended to include points #3 to 6 above.
Who cannot join
- Significant co-morbid disease that would pose a safety threat or impair ability to participate in an exercise program
- Inability or unwillingness to modify dietary or exercise behaviours.
- Knee X-Ray within the last 2 years
- Inability to speak and write English
- Knee pain due only to referred pain from osteoarthritis of the hip
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
This will be a pilot study of a multidisciplinary intervention for individuals with knee pain with a high likelihood of knee OA that could be a model for other chronic diseases. The intervention will be multidisciplinary such that it will be initiated by community pharmacists with referral to a comprehensive OA treatment program at the provincial arthritis center involving physiotherapists. In addition, formal communication will be initiated with their family doctor. Those in the usual care group will receive an educational OA pamphlet. The primary objective of this pilot project is to determine the proportion of patients who meet the Arthritis Foundation's Quality Indicator Set for osteoarthritis in the treatment arm compared to those in the usual care arm. Specifically, this indicator set focuses on health service provision within the first few months of diagnosis which includes physical examination, radiographs, education, exercise, weight loss, assistive devices and pharmacologic therapy.
- Conditions
- Knee Osteoarthritis
- Being tested
- Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA)
- Keywords
- Pharmacist-initiated Intervention Trial in OsteoArthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA)Procedure or surgery
See Detailed Description.
| Study group | Role | What they receive |
|---|---|---|
| Health service provision | Experimental | Health service provision within the first few months of diagnosis which includes physical examination, radiographs, education, exercise, weight loss, assistive devices and pharmacologic therapy. Receives: Procedure: Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
(Baseline, months 2 and 6 )
Measured: Months 2 and 6
Secondary outcomes (5)
There are four secondary outcome measures that will be compared between intervention and usual care subjects at baseline, months 2 and 6:
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Arthritis Network, Michael Smith Foundation for Health Research
- Responsible party
- Sponsor
- Investigators
- Carlo Marra, Ph.D, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391859
- Sponsor's protocol ID
- H06-70373
- Other IDs
- H06-70373
- Status last verified
- Mar 2014
- First submitted
- 24 Oct 2006
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Marra CA, Cibere J, Grubisic M, Grindrod KA, Gastonguay L, Thomas JM, Embley P, Colley L, Tsuyuki RT, Khan KM, Esdaile JM. Pharmacist-initiated intervention trial in osteoarthritis: a multidisciplinary intervention for knee osteoarthritis. Arthritis Care Res (Hoboken). 2012 Dec;64(12):1837-45. doi: 10.1002/acr.21763.
PubMed 22930542
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-initiated Intervention Trial in OsteoArthritis (PhIT-OA)
- ClinicalTrials.gov ID
- NCT00391859
- Acronym / sponsor ID
- H06-70373
- Conditions
- Knee Osteoarthritis
- Keywords
- Pharmacist-initiated Intervention Trial in OsteoArthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Arthritis Network, Michael Smith Foundation for Health Research
- Study start
- Sep 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Oct 2006 (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.
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.
Detailed description
This will be a pilot study of a multidisciplinary intervention for individuals with knee pain with a high likelihood of knee OA that could be a model for other chronic diseases. The intervention will be multidisciplinary such that it will be initiated by community pharmacists with referral to a comprehensive OA treatment program at the provincial arthritis center involving physiotherapists. In addition, formal communication will be initiated with their family doctor. Those in the usual care group will receive an educational OA pamphlet. The primary objective of this pilot project is to determine the proportion of patients who meet the Arthritis Foundation's Quality Indicator Set for osteoarthritis in the treatment arm compared to those in the usual care arm. Specifically, this indicator set focuses on health service provision within the first few months of diagnosis which includes physical examination, radiographs, education, exercise, weight loss, assistive devices and pharmacologic therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health service provision | Experimental | Procedure: Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA)Health service provision within the first few months of diagnosis which includes physical examination, radiographs, education, exercise, weight loss, assistive devices and pharmacologic therapy. |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >50 years
- ≥ 4 weeks of pain, aching or discomfort in or around the knee
- Overweight or obese defined as BMI defined as ≥ 27 kg/m2
- Not actively participating in a formal exercise program within the past 6 months
- Self-reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking one quarter of a mile, getting in and out of a chair, or going up and down stairs.
Key exclusion criteria (5 listed)
- Significant co-morbid disease that would pose a safety threat or impair ability to participate in an exercise program
- Inability or unwillingness to modify dietary or exercise behaviours.
- Knee X-Ray within the last 2 years
- Inability to speak and write English
- Knee pain due only to referred pain from osteoarthritis of the hip
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA)See Detailed Description. | Procedure or surgery | Health service provision |
Primary outcome
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
5 secondary outcomes
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.
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 17 Mar 2014.
- Derived from this study: PubMed 22930542Marra CA, Cibere J, Grubisic M, Grindrod KA, Gastonguay L, Thomas JM, Embley P, Colley L, Tsuyuki RT, Khan KM, Esdaile JM. Pharmacist-initiated intervention trial in osteoarthritis: a multidisciplinary intervention for knee osteoarthritis. Arthritis Care Res (Hoboken). 2012 Dec;64(12):1837-45. doi: 10.1002/acr.21763.
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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.
Carlo Marra, Ph.D principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA) in people with Knee Osteoarthritis, run by University of British Columbia at 1 site in Canada.
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 6 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 17 Mar 2014. 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 Canada. 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.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391859, which also lists 1 linked publication.
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 17 Mar 2014.