OA Optimization Program Pilot Trial

Phase 1

Active, not recruiting

• Conditions: Osteo Arthritis Knee; Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis
• Interventions: Behavioral: Alberta Obesity Centre Program; Behavioral: Alberta Healthy Living Program; Behavioral: Osteoarthritis advice; Behavioral: Physiotherapy

• Registration Number: NCT05389371
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-25
• Study Start: 2022-06-28
• Status Verified: 2023-11
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22
• Primary Completion: 2024-08-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alberta Obesity Centre Program	Osteoarthritis advice	Evidence-based medical management of obesity using a multidisciplinary approach.
Alberta Healthy Living Program	Physiotherapy	An integrated community-based chronic disease management program available to residents of Alberta.
Alberta Healthy Living Program	Osteoarthritis advice	An integrated community-based chronic disease management program available to residents of Alberta.
Alberta Obesity Centre Program	Alberta Obesity Centre Program	Evidence-based medical management of obesity using a multidisciplinary approach.
Alberta Obesity Centre Program	Physiotherapy	Evidence-based medical management of obesity using a multidisciplinary approach.
Alberta Healthy Living Program	Alberta Healthy Living Program	An integrated community-based chronic disease management program available to residents of Alberta.

Primary Outcome Measures

Name	Time	Method
The number and percentage of participants retained at 12-months	0-12 months	Number and percentage of patients attending at 12-month follow up and reasons for drop-out
Determine the number of adults with osteoarthritis and obesity that are eligible to participate in the trial	0-12 months	The number of patients approached
The number of these adults with osteoarthritis and obesity who would be willing to take part in this trial	0-12 months	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	0-12 months	Patient sex, gender, age, and medical history

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada