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临床试验/NCT05393349
NCT05393349Unknown不适用

'Home Sweet Home' Programme: Empowering the Patient and Caregiver for Early and Safe Discharge of Patients With Geriatric Hip Fractures

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2019年9月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
142
试验地点
1
主要终点
Walking function

研究概览

简要总结

Objective:

To study whether fracture hip patients can be benefited from the empowerment program

Hypothesis to be tested Primary hypothesis: empowerment program can improve the patient's functional recovery.

Secondary hypothesis: the program can improve readmission rate, length of stay, and secondary fracture.

Design and subjects This is a prospective randomised controlled trial and subjects are fracture hip patients

Instruments Ipads are needed to show the videos of the rehabilitation program

Interventions

The empowerment program consists of three main areas which directly correspond to the contents that the patients and caregivers expressed as most needed in interviews conducted by the investigators during hip fracture patients' follow up:

  • Knowledge of the disease
  • Confidence and skills in self-care management
  • Support in the post-discharge period

Main outcome measures

Primary outcomes:

Functional scores (Modified Barthel Index and EQ-5D-5L) at the first follow-up visit (3 months postop).

Timed-up-and-go test at follow-up at 6 months and 1 year.

Secondary outcome:

Cumulative readmission rates at 1 month, 6 months, and 1 year The length of stay in the convalescent hospital Subsequent injury with fractures within 1 year

Data analysis Chi-square test is used for categorical variables. For continuous variables, the normal distribution is determined by the Kolmogorov-Smirnov test. Independent t-test is used for comparing average values of normally distributed continuous variables, while the Wilcoxon rank sum test is used for comparing median values of abnormally distributed variables.

Binary logistic regression is used to determine predictive factors for outcomes. Multivariate analysis is performed to verify independent predictive factors for outcomes.

Expected results Fracture hip patients can be benefited from the empowerment program.

详细描述

Introduction:

Health care consequences of hip fracture The global incidence of geriatric hip fractures is projected to increase by more than 250% in the next twenty-five years. Local data showed that there was a steady increase from 3500 to more than 4500 hip fractures per year from 2000 to 2011. Nevertheless, the consequence of hip fractures is serious and costly. Ten percent of patients have a contralateral hip fracture, 30% of the patients are readmitted for other acute reasons, 25% need long-term care, 10-25% die within 1 year and almost 50% have residual functional disabilities.

Geriatric hip fracture clinical pathway decreased preoperative length of stay Since 2006, the geriatric hip fracture clinical pathway (GFH) has been implemented in the Hong Kong West Cluster. The implementation of GFH resulted in a decreased preoperative length of stay, decreased surgical site infection, decreased pressure sore, and decreased 30-day and 12-month mortality rate.

High dependency of patients upon discharge:

However, according to our data, a significant number of patients still required an extended length of stay, which is defined as more than 28 days in a rehabilitation hospital. More than 60% of the patients were discharged home, however, 39% and 51% of the patients had severe and moderate dependency respectively upon discharge from the rehabilitation hospital (Modified Barthel Index 0-60 and 61-90 respectively). Current training provided to those patients and their caregivers was brief and inadequate. The lack of a trained caregiver affects the decision to return home and patients may need settlement in nursing homes. Moreover, 12% had readmission within 28 days of discharge, with repeated falls accounting for the majority.

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
None

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

  • Acute intracapsular or extracapsular proximal femur fracture
  • Surgical treatment: Hemiarthroplasty or reduction-internal fixation
  • Availability of caregiver

排除标准

  • No caregiver support
  • Non-operative treatment
  • Pathological fracture
  • Multiple fractures
  • Patient discharged directly from the acute hospital without convalescence
  • Premorbid bedbound/chairbound status

结局指标

主要结局

Walking function

时间窗: 1 year

Timed-up-and-go test

Functional scores

时间窗: First follow up visit (3 months postop)

Modified Barthel Index

次要结局

  • Cumulative readmission rates(2 years after hip surgery)
  • The length of stay in convalescent hospital(Up to discharge back to home)
  • Number of subsequent injury with fractures(within 2 years)

研究者

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

Dr. Wong Tak-Man

Clinical Associate Professor

The University of Hong Kong

研究点 (1)

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