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临床试验/NCT02614430
NCT02614430已完成不适用

Recover Working Life - Back on the Job After Acute Illness. A Study of the Effect on Functional Capacity and Self-rated Health and Working Capacity of a Vocational Training Course After Discharge From an Acute Hospitalisation

Hvidovre University Hospital2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Day of recovery after sick leave

研究概览

简要总结

The project will investigate levels of physical, psychosocial functions and inflammatory biomarkers in a group of patients who by self-assessment indicates a perceived risk of decline in work ability after hospital admittance. The patients will be randomised to an intervention of physical training and followed for development in functional levels compared with patients not receiving the intervention. The goal is to validate measures of work ability assessment in connection to hospital admittance. The validation will provide important information about the quality of rehabilitation services that many municipalities provides through private suppliers - and where the effect on work ability lacks evidence-based documentation.

The project aims to link patient treatment to recovery and an optimal return to everyday life, comprising the patients work life. The frame is a multi-sectoral accepted platform for assessing patients' needs for care, treatment and rehabilitation, which is based on a professional assessment of the efficacy and quality of, varies heath care related deliveries. The acceptance of a multi-sectoral creates a need for accessible clinical tests of physical and mental functioning, combined with biomarkers to identify patients need.

The project investigates whether it is possible to identify patients (age 18 to 60 year) with an increased risk of losing their ability to work after discharge from an acute hospitalisation. And to evaluate whether measurable effects on inflammation and functional levels of labour oriented training program can be identified.

详细描述

The project will examine the validity of identification of patients in risk of decreased work ability during and after hospitalisation and the effect of early intervention on the physical and mental functional level. The project consists of a pilot study and two clinical studies investigating the following:

  • The validity of work ability assessments by a self-administered questionnaire during hospitalisation.
  • The development in the inflammatory response after discharge in relation to the development in self-rated health.
  • The effect of a labour oriented training program measured in inflammatory response and functional level.
  • The effect of a labour oriented training program on work ability after discharge.

The self-administered questionnaire Work Ability Index will be tested and evaluated during the pilot study.

Study 1 is a prospective cohort study testing the identification tool for decreased work ability including inflammatory biomarkers and functional levels after discharge.

Study 2 is a randomised controlled intervention study of the effect of a labour oriented training program initiated within 2 weeks after discharge on functional level and self-rated health.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Acute medical/surgical patients between 18 to 60 years
  • Patients who have been hospitalised for at least 12 hours
  • Are entitled to sickness or unemployment benefits either from the employer or municipality
  • Patients who have an increased risk of loss of earning capacity of> 50% relative for the total group of patients in the pilot study

排除标准

  • Patients unable to cooperate
  • Patients with end-stage disease
  • Patients with major trauma

研究组 & 干预措施

Vocational training

Active Comparator

Participants are randomized into the intervention group (training) where they are offered a training course of 4-9 weeks of physical training three times a week with a physiotherapist.

干预措施: Vocational training (Other)

Control

No Intervention

Participants are randomized into the control group where they are offered the standard treatment.

结局指标

主要结局

Day of recovery after sick leave

时间窗: From discharge to 52 weeks after discharge

Time to recovery date from discharge is defined the first day back at work after sick leave. Data on day of recovery will be subtracted from register kept by Statistics Denmark.

次要结局

  • Diagnose(From admission (Baseline) to 12 weeks after discharge)
  • SuPAR(From 2 weeks after discharge to 12 weeks after discharge)
  • Hand-grip strength of dominant hand(Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge)
  • Work Ability Index (WAI)(From Admission (baseline), 2 weeks -, 12 weeks - and 52 weeks after discharge.)
  • Readmission(From discharge to 52 weeks after discharge)
  • Medication(From discharge to 12 weeks after discharge)
  • Day of recovery after sick leave(From discharge to 12 weeks after discharge)
  • Health Related Quality of Life (EQ-5D)(Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge)
  • Doctor visits(From discharge to 52 weeks after discharge)
  • Habitual gait speed(Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge)
  • Major Depression Inventory (MDI)(Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge)

研究者

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

Ove Andersen

Research Director

Hvidovre University Hospital

研究点 (2)

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