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临床试验/NCT05712252
NCT05712252进行中(未招募)不适用

Risk Factors for Fall and Fracture - A Cohort Study of Fall-related Factors Obtained in Routine Orthopaedic Fracture Care

Region Skane1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
Region Skane
入组人数
1,200
试验地点
1
主要终点
Mortality

研究概览

简要总结

This project aims to improve the global outcome for an aging individual after a traumatic fall, through identifying conditions contributing to a fall and promoting recovery and rehabilitation. Through better understanding 'falling phenotype', the ultimate aim is to prevent future complications, as well as new falls and fractures in the growing older population.

详细描述

Background: The knowledge of risk factors for falls and fractures amongst older individuals are enormous, still identification of fallers and prevention of falls is not part of Swedish standard of care. Some risk factors are more or less overlooked, such as alcohol consumption, orthostatic reactions, as are increased risks related to common medications such as certain antidepressants, opioids and sedatives. Although functional activity and frailty scores have been suggested to be potential predictors of adverse events, length of hospital stay and mortality, the use of standardized questionnaires has not been implemented in routine care in Sweden. Furthermore, outcomes after fragility fractures, a well known consequence of falls among older individuals, are continuously poor, although palpable improvements have been reached regarding surgical treatment. Are there other factors that are equally or more decisive for the global outcome from the patient's point of view?

Material & Methods: In this prospective observational cohort study, all in-patients treated due to a fall-related trauma (fracture, dislocation or contusion) at the Department of Orthopaedics, Skane University Hospital Malmö, aged 65 years or older will be invited to participate during a 1-year study period. In all participants, a standard package of blood samples, temperature, measurement of orthostatic blood pressure and grip strength, grading of frailty and activity will be routinely obtained.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 65 years or older at the time of admission.
  • Admitted to Orthopaedic ward at due to fall, with or without a fracture.

排除标准

  • Severe head trauma or other severe non-orthopaedic trauma.
  • Other condition requiring ward at other department (CCU, ICU) >24 hours.
  • Moribund individuals with palliative care only.
  • Declined to participate
  • Fall > 7 days before admission
  • Residence outside the region (lack of follow-up)

结局指标

主要结局

Mortality

时间窗: One year after admission to hospital

The number of deaths during follow-up

Other adverse events

时间窗: One year after admission to hospital

Other adverse events that are not included in outcome measure 1 or 2, such as infection, new falls, fractures, or complications from previous fall/fracture, or other medical complications. These can be further grouped by whether the events occur in in-patient or out-patient care.

Re-admission

时间窗: One year after admission to hospital

Number of re-admissions to emergency centre or in-patient ward due to a new fall (primarily) or complications related previous fall/fracture

次要结局

未报告次要终点

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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