OsteoarthritisNCT00297726
A Study to Examine the Efficacy of the Arthritis Self Management Program
A study testing Self-Management Program in people with Osteoarthritis, run by Alberta Bone and Joint Health Institute.
Trial summary
This study will examine the efficacy of the Arthritis Self Managemnet Program (ASMP)and determine changes in health resource utilization after completeing the ASMP program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Self-Management Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Apr 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OA of the hip and/or knee
- Patient is 18 years of age and over
Who cannot join
- a concurrent systemic inflammatory disease
- Patient has previously participated in an arthritis self management educational program
- Patient is awaiting total hip or total knee replacement surgery patient has a medical co-morbidity that would render the patient to participate fully in the study procedures, including terminal conditions such as chronic obstructive pulmonary disease, end stage renal disease, heart failure, malignancy with anticipated life expectancy of equal to or less than 2 years
- Patient has been diagnosed with senile dementia or Alzheimer's disease
About this study
Official title: A Prospective Study to Examine the Efficacy of the Arthritis Self Management Program (ASMP) in Patients With Osteoarthritis (OA) in Alberta
This study will examine the efficacy of the Arthritis Self Managemnet Program (ASMP)and determine changes in health resource utilization after completeing the ASMP program.
Read the detailed description
This study will provide an analysis of the efficacy of the Arthritis Self Management Program (ASMP) using both patient administered questionnaires as well as the health utilization data maintained within the administrative databases at Alberta Health and Wellness. This study will also provide other information that has not yet been evaluated in other arthritis self management studies including co-morbidity data and other specific health related utilization information that has not yet been evaluated in other arthritis self management studies including co-morbidity data and other specific health related utilization information as it is recorded in administrative databases, will include a control group and will adjust for potential confounding variables such as sex, age, body mass index (BMI) and stage of disease.
- Conditions
- Osteoarthritis
- Being tested
- Self-Management Program
- Keywords
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis, Ankle, Arthritis, Self-Management
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Management ProgramBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
A difference in the WOMAC score of 20 percentage points
Secondary outcomes (1)
A change in health care provider and medication utilization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study startOct 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 64 participants
Sponsor and investigators
- Lead sponsor
- Alberta Bone and Joint Health Institute
- Sponsor type
- University, hospital or other
- Investigators
- Cyril B Frank, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297726
- Sponsor's protocol ID
- PRO-OA-00001
- Status last verified
- Feb 2006
- First submitted
- 27 Feb 2006
- Last updated
- 1 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Examine the Efficacy of the Arthritis Self Management Program (ASMP) in Patients With Osteoarthritis (OA) in Alberta
- ClinicalTrials.gov ID
- NCT00297726
- Acronym / sponsor ID
- PRO-OA-00001
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis, Ankle, Arthritis, Self-Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants
- Lead sponsor
- Alberta Bone and Joint Health InstituteUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Apr 2006
- First posted
- 1 Mar 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.
This study will examine the efficacy of the Arthritis Self Managemnet Program (ASMP)and determine changes in health resource utilization after completeing the ASMP program.
Detailed description
This study will provide an analysis of the efficacy of the Arthritis Self Management Program (ASMP) using both patient administered questionnaires as well as the health utilization data maintained within the administrative databases at Alberta Health and Wellness. This study will also provide other information that has not yet been evaluated in other arthritis self management studies including co-morbidity data and other specific health related utilization information that has not yet been evaluated in other arthritis self management studies including co-morbidity data and other specific health related utilization information as it is recorded in administrative databases, will include a control group and will adjust for potential confounding variables such as sex, age, body mass index (BMI) and stage of disease.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- OA of the hip and/or knee
- Patient is 18 years of age and over
Key exclusion criteria (4 listed)
- a concurrent systemic inflammatory disease
- Patient has previously participated in an arthritis self management educational program
- Patient is awaiting total hip or total knee replacement surgery patient has a medical co-morbidity that would render the patient to participate fully in the study procedures, including terminal conditions such as chronic obstructive pulmonary disease, end stage renal disease, heart failure, malignancy with anticipated life expectancy of equal to or less than 2 years
- Patient has been diagnosed with senile dementia or Alzheimer's disease
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 |
|---|---|---|
| Self-Management Program | Behavioural | – |
Primary outcome
A difference in the WOMAC score of 20 percentage points
1 secondary outcome
A change in health care provider and medication utilization.
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 1 Mar 2006.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Cyril B Frank, MD principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management Program in people with Osteoarthritis, run by Alberta Bone and Joint Health Institute.
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 2 inclusion and 4 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 1 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
A difference in the WOMAC score of 20 percentage points. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2006.