OA Optimization Program Pilot Trial
Primary Purpose
Osteo Arthritis Knee, Osteoarthritis, Knee, Osteoarthritis, Hip
Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Alberta Healthy Living Program
Alberta Obesity Centre Program
Osteoarthritis advice
Physiotherapy
Sponsored by
About this trial
This is an interventional prevention trial for Osteo Arthritis Knee
Eligibility Criteria
Inclusion Criteria:
- body mass index (weight in kilograms divided by height in metres squared) greater than 30
- symptomatic osteoarthritis (referred to the Alberta Hip and Knee Clinic for assessment for total joint replacement surgery)
Exclusion Criteria:
- Currently following a specialized or therapeutic diet
- pregnant or breastfeeding
- diagnosed with type 1 diabetes
- unable to read or speak English
- unable to use email
- unable to use virtual platforms such as Zoom
Sites / Locations
- University of CalgaryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Alberta Healthy Living Program
Alberta Obesity Centre Program
Arm Description
An integrated community-based chronic disease management program available to residents of Alberta.
Evidence-based medical management of obesity using a multidisciplinary approach.
Outcomes
Primary Outcome Measures
Determine the number of adults with osteoarthritis and obesity that are eligible to participate in the trial
The number of patients approached
The number of these adults with osteoarthritis and obesity who would be willing to take part in this trial
The number of patients who actually enroll
The characteristics of these adults with osteoarthritis and obesity who are willing to take part in the trial
Patient sex, gender, age, and medical history
The number and percentage of participants retained at 12-months
Number and percentage of patients attending at 12-month follow up and reasons for drop-out
Secondary Outcome Measures
Change in body mass
Change in body mass (weight loss)
Decision to proceed with joint replacement surgery
Yes/no decision to proceed with joint replacement surgery
Change in waist circumference
waist circumference (centimetres)
Change in blood pressure
blood pressure (millimetres of mercury)
Change in blood lipid profile
blood lipids
Change in glycemic control
glycated hemoglobin (HbA1c)
Change in quality of life
Quality of life measured by the Alberta Bone and Joint Health Institute Hip and Knee Replacement Outcomes Tool
Change in medication usage
All prescription medications will be tracked and recorded by a study physician
Full Information
NCT ID
NCT05389371
First Posted
May 19, 2022
Last Updated
May 11, 2023
Sponsor
University of Calgary
Collaborators
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT05389371
Brief Title
OA Optimization Program Pilot Trial
Official Title
Use of a Virtual Weight Management Program to Enable Weight Loss and Improve Metabolic Health and Quality of Life for Patients With Osteoarthritis and Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Total joint replacement is a highly successful treatment option for people affected by severe osteoarthritis (OA), however, the mismatch between resources and demand for this surgery means that many patients face long wait times while enduring worsening pain and disability. The Alberta Hip and Knee Program is a centralized intake system for patients referred for total joint replacement assessment. Over 3000 patients are assessed annually at the Calgary location (Alberta Hip and Knee Clinic at Gulf Canada Square) where previously patients waited an average of 43 weeks for a surgical consult then an additional 30 weeks until surgery. Given that many elective surgeries in Alberta have been cancelled in response to the COVID19 pandemic, these wait times have increased significantly, with no clearing of the surgical backlog for the foreseeable future. Long wait times for patients can become a spiral of more debility, less mobility, and subsequent weight gain. The current standard of care for patients with obesity awaiting surgery provides little support or guidance beyond general advice about the importance of a healthy weight and remaining active. This waiting period represents an untapped window of opportunity to intervene and help patients with obesity and OA to lessen their disease burden and improve overall health, while addressing patient priorities such as regaining lost function and improving quality of life.
Many patients with osteoarthritis also have obesity. The best practices in obesity treatment requires a multidisciplinary approach. Our aim is to conduct a pilot randomized controlled trial (RCT) to evaluate the feasibility of incorporating the multidisciplinary Alberta Obesity Centre program into the clinical care pathway for patients with obesity and OA while they await surgical evaluation at the Alberta Hip and Knee Clinic at Gulf Canada Square. The results of this feasibility trial will help inform a larger scale trial that will be powered for clinical and health economics outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
parallel-arm randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alberta Healthy Living Program
Arm Type
Active Comparator
Arm Description
An integrated community-based chronic disease management program available to residents of Alberta.
Arm Title
Alberta Obesity Centre Program
Arm Type
Experimental
Arm Description
Evidence-based medical management of obesity using a multidisciplinary approach.
Intervention Type
Behavioral
Intervention Name(s)
Alberta Healthy Living Program
Intervention Description
Weight management services
Intervention Type
Behavioral
Intervention Name(s)
Alberta Obesity Centre Program
Intervention Description
Multi-disciplinary obesity management
Intervention Type
Behavioral
Intervention Name(s)
Osteoarthritis advice
Intervention Description
Living Your Best Life with Osteoarthritis Handbook
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
GLA:D (TM) education and exercise
Intervention Description
GLA:D physiotherapy programs.
Primary Outcome Measure Information:
Title
Determine the number of adults with osteoarthritis and obesity that are eligible to participate in the trial
Description
The number of patients approached
Time Frame
0-12 months
Title
The number of these adults with osteoarthritis and obesity who would be willing to take part in this trial
Description
The number of patients who actually enroll
Time Frame
0-12 months
Title
The characteristics of these adults with osteoarthritis and obesity who are willing to take part in the trial
Description
Patient sex, gender, age, and medical history
Time Frame
0-12 months
Title
The number and percentage of participants retained at 12-months
Description
Number and percentage of patients attending at 12-month follow up and reasons for drop-out
Time Frame
0-12 months
Secondary Outcome Measure Information:
Title
Change in body mass
Description
Change in body mass (weight loss)
Time Frame
0-12 months
Title
Decision to proceed with joint replacement surgery
Description
Yes/no decision to proceed with joint replacement surgery
Time Frame
12 months
Title
Change in waist circumference
Description
waist circumference (centimetres)
Time Frame
0-12 months
Title
Change in blood pressure
Description
blood pressure (millimetres of mercury)
Time Frame
0-12 months
Title
Change in blood lipid profile
Description
blood lipids
Time Frame
0-12 months
Title
Change in glycemic control
Description
glycated hemoglobin (HbA1c)
Time Frame
0-12 months
Title
Change in quality of life
Description
Quality of life measured by the Alberta Bone and Joint Health Institute Hip and Knee Replacement Outcomes Tool
Time Frame
0-12 months
Title
Change in medication usage
Description
All prescription medications will be tracked and recorded by a study physician
Time Frame
0-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
body mass index (weight in kilograms divided by height in metres squared) greater than 30
symptomatic osteoarthritis (referred to the Alberta Hip and Knee Clinic for assessment for total joint replacement surgery)
Exclusion Criteria:
Currently following a specialized or therapeutic diet
pregnant or breastfeeding
diagnosed with type 1 diabetes
unable to read or speak English
unable to use email
unable to use virtual platforms such as Zoom
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Berchuk, MD
Phone
403-943-8720
Email
miriam.berchuk@ucalgary.ca
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Berchuk, MD
Phone
403-943-8720
Email
miriam.berchuk@ucalgary.ca
12. IPD Sharing Statement
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OA Optimization Program Pilot Trial
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