Recover Working Life - Back on the Job After Acute Illness
Condition: Specific Work Inhibition
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Primary aim of study 1: testing the validity of Work Ability Index in relation to
      observations on functional level and measurement of inflammatory biomarkers after discharge.

      Primary aim of study 2: examine the effect of labour oriented training on functional level
      and work ability.

      Following measuring tools will be used during the project: Work Ability Index, hand grip
      strength, gait speed (6M), Major Depression Inventory (MDI), Self-rated health (EQ-5D) and
      inflammatory biomarkers including markers for inflammatory receptors, cytokines and
      chemokines.

      Hand grip strength:

      The project manager and trained clinical staff will test participants included in study 1.
      Participants are tested for physical capacity measured by grip strength. This is assessed
      twice by a hand dynamometer for 5 seconds with his dominant hand and an average is
      calculated.

      Gait speed (6M):

      Physical function is measured by a walking test of 6 m. The participants are measured from a
      starting line with the message to go in for them normal pace on a marked field of 8 m. The
      time is measured when the first foot reaches the 6m point and the test is repeated, after
      which an average is calculated.

      Major Depression Inventory (MDI):

      MDI is a depression questionnaire to 10 symptoms, which is part of the World Health
      Organization's definition of depression. The table focuses on the patient's current
      experience of symptoms within the last two weeks and the changes that the disease extent and
      rehabilitation can cause. MDI is used in the study as a rating scale with a theoretical sum
      score from 0 (no depression) to 50 (maximum depression).

      EQ-5D:

      EQ-5D is a validated questionnaire to measure health status by a simple descriptive profile
      and a single index value, which is evaluated for clinical and health economic studies of
      self-rated health. The questionnaire was approved by the EuroQol Group, and includes
      questions about mobility, personal care, activity, depression and pain.

      Biomarkers:

      At admission, 2 - and 12 weeks after discharge blood sample is taken for analysis of
      inflammatory receptors, cytokines and chemokines. The analyses will be carried out as batch
      after sample collection by ELISA and / or Luminex technology.

      Total duration of the test, instruction and replies to the questionnaires represent a total
      of 45 minutes per. participant Patients who submit a written informed consent to participate
      based on an interview are randomised into an intervention or control group. The groups are
      stratified for hospitalisation due to medical and surgical reasons, physical work load and
      education to ensure an equitable distribution among participant receiving the intervention.

      The intervention is performed in public-private collaboration with a health care provider
      specialised in labour oriented training. The program consists of a physical training program,
      individual motivational talks and guidance on labour market-oriented topics. Each program is
      customised to the patient's physical resources and conditions. The scope of the intervention
      is physical activity 1-2 hours 3 times weekly with concurrent motivational talks for an
      overall of max. 9 weeks.

      The project aims to include 120 patients giving an interventions size of 50 participants and
      an estimated drop-out rate of 20%. The studies are carried out in accordance with the
      principles of the Helsinki Declaration.

      Participants are covered by Amager Hvidovre Hospital Patient Insurance. The collected data
      will be kept in accordance to the Data Protection Agency guidelines.

      The Project Manager will work with the clinical staff from the participating departments
      responsible for contacts with all patients who meet the inclusion criteria for the studies.
      Patients who meet the inclusion criteria will receive written and verbal information about
      the project including the advantages, disadvantages, risks and patient rights by
      participation in the project. The patient contacted by the project manager the day after the
      verbal and written information. If the patient wishes to participate in the project obtained
      accepted consent form and schedule time for tests and blood sampling.

      Results:

      The project will help to focus attention on an overlooked task in health care, where the
      patient after treatment can still be at risk of losing their ability to work. The project
      will also mean greater knowledge about the use of biomarkers and how these may reflect the
      development of the individual's refund and the current level of functioning.
    

Intervention name(s): Vocational training
Intervention type(s): Other
Intervention description(s): The intervention consists of a physical training program, individual motivational talks and guidance on labor market-oriented topics. Each program is customised to the patient's physical resources and conditions where. The framework for the intervention of physical activity 1 hours 3 times weekly with concurrent motivational talks for an overall maximum duration of 9 weeks. Based on an assessment of the patient is instructed about pain management, ergonomics, conflict management, diet, lifestyle, behavior modification, stress symptoms and preventive home training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Rehabilitation; Prediction; Inflammation