跳至主要内容
临床试验/NCT06842420
NCT06842420Enrolling By Invitation不适用

Model Development and Temporal Validation of the Predictive Factors for Return to Work After Stroke Rehabilitation

Changi General Hospital1 个研究点 分布在 1 个国家目标入组 1,375 人开始时间: 2023年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,375
试验地点
1
主要终点
Return to work

研究概览

简要总结

The purpose of the study is to develop a predictive model for return to work after stroke rehabilitation.

详细描述

Background Return to work post stroke is a key milestone for many survivors of stroke; however, many cannot achieve this goal. Based on the previous work by Tay et al, independent predictive factors were identified for return to work post inpatient stroke rehabilitation. In further works by Koh and Tay with the same dataset put through different models such as LASSO-Full, Lasso-Routine, ElasticNet-Full, etc suggests that the good discrimination performance of the return-to-work prediction models during internal validation supports a multisite, external validation study. Performing a temporal validation study is the interim step. A smaller part of the dataset could be used to further train the development model.

Significant economic costs are incurred because of stroke, which do not include further economic costs from the downstream loss of earnings and caregiver burden. Existing prediction models of return-to-work have area under the receiver operating characteristic curves (AUROCs) between 0.65 and 0.80. However, these models have not been assessed for calibration or clinical utility. No externally validated prediction model exists for return-to-work after stroke. There are advantages to having a prediction model. One of the concerns of patients and their families involve the loss of income as a result of stroke. The prediction model would help to prognosticate, as well as assist to set appropriate rehabilitation goals for the patient. Suitable patients can be directed to return to work services, if necessary.

Health is related to one's employment and financial position. Being able to return to gainful employment can result in better general and mental health5. People with disabilities employed in the past year reported better general and mental health than their peers with the same disabilities who were unemployed.

This study could be completed in 1 to 2 years and a prospective study involving external validation can be simultaneously performed with NUHS collaborators over 2 to 2.5 years. Both projects could be published in the next 2 to 3 years upon obtaining the grant for the temporal validation study. Thereafter, a Return to work calculator could be designed and launched in the next 4 years.

Hypothesis This study seeks to collect 1375 patient data who had completed inpatient stroke rehabilitation between the time periods of 2018-2025. We seek to further train our development model and to perform a temporal validation on this model.

研究设计

研究类型
观察性
观察模型
其他
时间视角
前瞻性

入排标准

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

入选标准

  • Completed inpatient stroke rehabilitation in CGH
  • Diagnosis of a first ever stroke
  • Patients who were working prior to stroke
  • Consent given

排除标准

  • Not first ever stroke
  • Did not require inpatient stroke rehabilitation
  • Not working prior to stroke
  • No consent obtained

结局指标

主要结局

Return to work

时间窗: 1 year and 2 years

Return to work at 1 year and 2 years post stroke

次要结局

未报告次要终点

研究者

申办方类型
其他
责任方
申办方

研究点 (1)

Loading locations...

标识符

NCT 编号
NCT06842420
其他研究编号
2023/2526

日期

首次提交
(去年)
首次发布
(去年)
主要完成日期
(6个月前)
研究完成日期
(6个月前)
最近核实
最近更新
(去年)

监管与共享

FDA 监管药物
否
个体参与者数据共享计划
否

Data is protected under the SingHealth Data Protection Policy which is compliant to the Singapore Personal Data Protection Act 2012

是否有结果
否

相似试验