OA Optimization Program Pilot Trial

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteo Arthritis Knee, Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis

Intervention / Treatment
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* Behavioral: Alberta Healthy Living Program
* Behavioral: Alberta Obesity Centre Program
* Behavioral: Osteoarthritis advice
* Behavioral: Physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel-arm randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alberta Healthy Living Program<br>An integrated community-based chronic disease management program available to residents of Alberta. | Behavioral: Alberta Healthy Living Program<br>* Weight management services<br>Behavioral: Osteoarthritis advice<br>* Living Your Best Life with Osteoarthritis Handbook<br>Behavioral: Physiotherapy<br>* GLA:D physiotherapy programs.<br>* Other names: GLA:D (TM) education and exercise;|
| Experimental: Alberta Obesity Centre Program<br>Evidence-based medical management of obesity using a multidisciplinary approach. | Behavioral: Alberta Obesity Centre Program<br>* Multi-disciplinary obesity management<br>Behavioral: Osteoarthritis advice<br>* Living Your Best Life with Osteoarthritis Handbook<br>Behavioral: Physiotherapy<br>* GLA:D physiotherapy programs.<br>* Other names: GLA:D (TM) education and exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the number of adults with osteoarthritis and obesity that are eligible to participate in the trial | The number of patients approached | 0-12 months | 
| 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 | 0-12 months | 
| 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 | 0-12 months | 
| 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 | 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass | Change in body mass (weight loss) | 0-12 months | 
| Decision to proceed with joint replacement surgery | Yes/no decision to proceed with joint replacement surgery | 12 months | 
| Change in waist circumference | waist circumference (centimetres) | 0-12 months | 
| Change in blood pressure | blood pressure (millimetres of mercury) | 0-12 months | 
| Change in blood lipid profile | blood lipids | 0-12 months | 
| Change in glycemic control | glycated hemoglobin (HbA1c) | 0-12 months | 
| Change in quality of life | Quality of life measured by the Alberta Bone and Joint Health Institute Hip and Knee Replacement Outcomes Tool | 0-12 months | 
| Change in medication usage | All prescription medications will be tracked and recorded by a study physician | 0-12 months |