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临床试验/NCT04424186
NCT04424186已完成不适用

Effect of Measuring Vital Signs and Coherent Rehabilitation in Primary and Secondary Sectors in Older Adults After Hip Fracture Surgery

Kolding Sygehus2 个研究点 分布在 1 个国家目标入组 339 人开始时间: 2020年9月22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
339
试验地点
2
主要终点
Timed up and go

研究概览

简要总结

Despite implementing hospital quality programs after hip fracture surgery older adults often experience a decline in the level of physical function, reduced quality of life; and the mortality and readmission rates are high.

Early mobilization is important in order to prevent loss of muscle mass; however to prevent morbidity an early start of strength training is also necessary. Furthermore, the risk of complications, morbidity, and mortality are associated with insufficient management of pain.

The project aims to examine the effect of measuring vital signs and consistent rehabilitation in the primary and secondary sectors in older adults after hip fracture surgery.

Method/ design:

The study is a cluster-randomized stepped wedge study. Participants will be recruited among patients admitted to an orthogeriatric ward who are 65 years of age or older and citizens in one of six municipalities. Participants are also the health professionals in the orthogeriatric ward and the six municipalities.

The six municipalities form six clusters, which are randomized, and every three-month one cluster cross from control to intervention.

The study compares usual practice (control) to an intervention named 'Rehabilitation of Life'. An intervention best described as an empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation and combined with convenient access for collaboration among professionals.

Primary outcomes: Timed Up and Go (TUG) measured 2 months after the time of operation.

The investigators hypothesize that 'Rehabilitation of Life' for older adults with a hip fracture will result in a significant reduced TUG-score in comparison to a practice not offering 'Rehabilitation of Life'.

And as the study is organised across two sectors, the Cumulated Ambulation Score (CAS) makes a second primary outcome. It is hypothesised that patients in the intervention group will achieve a significantly reduced TUG score compared to usual care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
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

  • Patients with a hip fracture
  • Patients of 65 years of age or older
  • Patients admitted to an orthogeriatric ward
  • Patient who are citizens in one og three municipalities

排除标准

  • Patients discharged for permanent residence in nursing homes
  • Patients who cannot participate in a conversation
  • Terminal registered patients.

结局指标

主要结局

Timed up and go

时间窗: Two months after the time of operation

Measures functional mobility, as the time in seconds it takes a person to rise from a chair with arms, walk 3 m and return to the chair. A higher scores mean a worse outcome

Cumulated Ambulation Score (CAS)

时间窗: One months after the time of operation

Measures basic mobility. The score 0-6. Higher scores mean a better outcome

次要结局

  • Timed up and go(Three and six months after the time of operation)
  • Barthel-20(2, 3, 6 and 12 months after the time of surgery)

研究者

发起方
Kolding Sygehus
申办方类型
Other
责任方
Sponsor

研究点 (2)

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