OA Optimization Program Pilot Trial

University of Calgary

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Osteoarthritis, Hip; Osteoarthritis; Osteoarthritis, Knee; Osteo Arthritis Knee

Treatments: Behavioral: Osteoarthritis advice; Behavioral: Alberta Obesity Centre Program; Behavioral: Alberta Healthy Living Program; Behavioral: Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05389371

REB19-1814

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Alberta Healthy Living Program

Active Comparator group

Description:

An integrated community-based chronic disease management program available to residents of Alberta.

Treatment:

Behavioral: Physiotherapy

Behavioral: Alberta Healthy Living Program

Behavioral: Osteoarthritis advice

Alberta Obesity Centre Program

Experimental group

Description:

Evidence-based medical management of obesity using a multidisciplinary approach.

Treatment:

Behavioral: Physiotherapy

Behavioral: Alberta Obesity Centre Program

Behavioral: Osteoarthritis advice