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临床试验/NCT05389371
NCT05389371进行中(未招募)1 期

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

University of Calgary2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年6月28日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
70
试验地点
2
主要终点
The number and percentage of participants retained at 12-months

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

The number and percentage of participants retained at 12-months

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 0-12 months

Patient sex, gender, age, and medical history

次要结局

  • Change in glycemic control(0-12 months)
  • Change in quality of life(0-12 months)
  • Change in waist circumference(0-12 months)
  • Change in blood lipid profile(0-12 months)
  • Change in body mass(0-12 months)
  • Decision to proceed with joint replacement surgery(12 months)
  • Change in blood pressure(0-12 months)
  • Change in medication usage(0-12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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