OA Optimization Program Pilot Trial

NCT ID: NCT05389371

Last Updated: 2024-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-28

Study Completion Date

2025-09-30

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.

Detailed Description

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Conditions

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Osteo Arthritis Knee Osteoarthritis, Knee Osteoarthritis, Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel-arm randomized trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Alberta Healthy Living Program

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

Group Type ACTIVE_COMPARATOR

Alberta Healthy Living Program

Intervention Type BEHAVIORAL

Weight management services

Osteoarthritis advice

Intervention Type BEHAVIORAL

Living Your Best Life with Osteoarthritis Handbook

Physiotherapy

Intervention Type BEHAVIORAL

GLA:D physiotherapy programs.

Alberta Obesity Centre Program

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

Group Type EXPERIMENTAL

Alberta Obesity Centre Program

Intervention Type BEHAVIORAL

Multi-disciplinary obesity management

Osteoarthritis advice

Intervention Type BEHAVIORAL

Living Your Best Life with Osteoarthritis Handbook

Physiotherapy

Intervention Type BEHAVIORAL

GLA:D physiotherapy programs.

Interventions

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Alberta Healthy Living Program

Weight management services

Intervention Type BEHAVIORAL

Alberta Obesity Centre Program

Multi-disciplinary obesity management

Intervention Type BEHAVIORAL

Osteoarthritis advice

Living Your Best Life with Osteoarthritis Handbook

Intervention Type BEHAVIORAL

Physiotherapy

GLA:D physiotherapy programs.

Intervention Type BEHAVIORAL

Other Intervention Names

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GLA:D (TM) education and exercise

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB19-1814

Identifier Type: -

Identifier Source: org_study_id

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