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临床试验/NCT03153943
NCT03153943已完成不适用

HIP Mobile: A Community-based Monitoring, Rehabilitation and Learning e-System for Patients Following a Fracture

McGill University Health Centre/Research Institute of the McGill University Health Centre6 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2017年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
6
主要终点
Change in mobility

研究概览

简要总结

Approximately 30,000 adults in Quebec over the age of 50 suffer a fragility fracture each year. Fractures can affect a person's health, well-being and autonomy. Personal costs of these fractures are high, with as many as 50% of hip fracture patients being unable to return their pre-fracture level of autonomy.

Homecare and community services provide customary rehabilitation support immediately following discharge from acute-care, though this contribution can be limited by lack of resources. For those patients at risk of negative outcomes, we have demonstrated clinically important benefits of extended exercise rehabilitation programs offered beyond the regular rehabilitation period on improving physical function.

Through advances in sensor and telecommunication technology, eHealth solutions incorporated within homecare services as an integral part of the continuum of care can lead to better patient and health professional experience, improve clinical outcomes and reduce costs to the healthcare system.

The purpose of this study is to determine if the implementation of a 3-month community-based extended-rehabilitation e-Monitoring and Coaching support program is more effective at improving mobility in community-dwelling elderly patients who have sustained a fracture than a printed material support program, and if these effects persist 6 months after discontinuation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Community dwelling men and women aged ≥ 60 years
  • Treated for any fracture excluding hands, feet, patella, cervical spine, skull, ribs, or clavicle, at any of the 3 participating sites, within the previous 8 weeks.

排除标准

  • Upper limb fractures that do not meet the criteria of gait frailty
  • Multiple traumas
  • Open fractures
  • Pathological fractures
  • Inability to communicate adequately in either French or English
  • Inability to give written informed consent
  • Discharge to a long-term care institution

结局指标

主要结局

Change in mobility

时间窗: 0, 1, 3, and 7 months

Measured as an ordinal mobility response variable quantified by the number of minimal clinically important changes (MIC) a participant attains using the gait speed and 30 second Sit to Stand tests. A person making no MIC in either measure is given a response category of 0, the lowest. A person changing by 1 MIC on only of the measures (either one) will be given a value of 1; a MIC gain on both measures would be assigned a value of 2, and so forth.

次要结局

  • Change in grip strength(0, 1, 3, and 7 months)
  • Change in the spatial area an individual moves through(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months)
  • Change in global function status(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months)
  • Change in perceived physical health status(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months)
  • Change in walking endurance(0, 1, 3, and 7 months)
  • Change in Health-related quality of life(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months)
  • Change in global quality of life (QOL)(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months)
  • Change in cognition(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months)
  • Change in balance(0, 1, 3, and 7 months)
  • Change in patient-reported health perception(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months)
  • Change in goal directed behavior(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months)
  • Change in confidence in maintaining balance while doing daily activities.(0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzanne Morin

Dr.

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (6)

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