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A Study to Examine the Efficacy of the Arthritis Self Management Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00297726
Recruitment Status : Completed
First Posted : March 1, 2006
Last Update Posted : March 1, 2006
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Osteoarthritis Behavioral: Self-Management 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Educational/Counseling/Training
Official Title: A Prospective Study to Examine the Efficacy of the Arthritis Self Management Program (ASMP) in Patients With Osteoarthritis (OA) in Alberta
Study Start Date : October 2004
Estimated Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. A difference in the WOMAC score of 20 percentage points

Secondary Outcome Measures :
  1. A change in health care provider and medication utilization.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OA of the hip and/or knee
  • Patient is 18 years of age and over

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00297726


Sponsors and Collaborators
Alberta Bone and Joint Health Institute
Investigators
Principal Investigator: Cyril B Frank, MD University of Calgary
More Information

ClinicalTrials.gov Identifier: NCT00297726     History of Changes
Other Study ID Numbers: PRO-OA-00001
First Posted: March 1, 2006    Key Record Dates
Last Update Posted: March 1, 2006
Last Verified: February 2006

Keywords provided by Alberta Bone and Joint Health Institute:
Osteoarthritis, Knee
Osteoarthritis, Hip
Osteoarthritis, Ankle
Arthritis
Self-Management

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases