跳至主要内容
临床试验/NCT04709393
NCT04709393进行中(未招募)不适用

The Effects of FRAX+SARC-F Questionnaire Pre-screening on Promoting Public Awareness of Fragility Fracture and Fall Prevention Among Community-dwelling Older Adults

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 2,956 人开始时间: 2021年5月7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)
入组人数
2,956
试验地点
1
主要终点
proportions of participants diagnosed with osteoporosis in the FRAX+SARC-F pre-screening and control groups.

研究概览

简要总结

Hip fragility fractures are a major threat to functional independence in older adults locally and globally. In Hong Kong, the prevalence of osteoporosis and osteopenia in people aged >50 years were reported to be as high as 37% and 52%, respectively. The major challenge in fragility fracture prevention is that fragility fracture is caused by the combination of osteoporosis and propensity to fall, and both of these conditions are multifactorial. Ample evidence shows that fall risks can be reduced by well-designed exercises, and osteoporosis can be effectively diagnosed by Dual-energy X-ray Absorptiometry imaging (DXA) and treated with anti-osteoporosis medication. Lifestyle modifications e.g. diet, optimal physical activity, environmental safety can also help to prevent falls or improve bone health. The brief Fracture Risk Assessment Tool (FRAX) and SARC-F provide a low cost of prescreening for fracture risk and sarcopenia, respectively. Using SARC-F in conjunction with FRAX has increased sensitivity for hip fracture risk prediction. FRAX+SARC-F may help increase the public awareness of osteoporosis and get the at-risk group to receive diagnostic tests and be treated. This model should fit in well with the coming District Health Centres across Hong Kong.

详细描述

Participants will be randomly assigned to either the pre-screening or control group in a 1:1 ratio. Independent personnel not involved in data collection or intervention will perform and conceal the randomization using an online data server. Research assistants who are blinded to the group allocation will conduct all the baseline assessments and subsequent event surveillance. All data will also be entered and checked by the blinded research assistants. All procedures concur with the Declaration of Helsinki (2013).

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
Double (Investigator, Outcomes Assessor)

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

  • aged ≥ 65 years
  • living in the community

排除标准

  • cannot follow the instruction

结局指标

主要结局

proportions of participants diagnosed with osteoporosis in the FRAX+SARC-F pre-screening and control groups.

时间窗: within 1-6 months

proportions of participants diagnosed with osteoporosis in the FRAX+SARC-F pre-screening and control groups.

次要结局

  • Rate of receiving osteoporosis screening(6-12 months)
  • rate of receiving fall risk assessment(6-12 months)
  • rate of receiving fall prevention intervention(6-12 months)
  • subsequent fall rate(12 months)
  • subsequent fracture rate(12 months)
  • rate of receiving anti-osteoporosis intervention(6-12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Timothy Kwok

Professor

Chinese University of Hong Kong

研究点 (1)

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