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Recover Working Life - Back on the Job After Acute Illness

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ClinicalTrials.gov Identifier: NCT02614430
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Amager Hospital
Information provided by (Responsible Party):
Ove Andersen, Hvidovre University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Specific Work Inhibition Other: Vocational training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2015
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : September 1, 2017

Arm Intervention/treatment
Active Comparator: Vocational training
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.
Other: Vocational training
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.

No Intervention: Control
Participants are randomized into the control group where they are offered the standard treatment.



Primary Outcome Measures :
  1. Day of recovery after sick leave [ Time Frame: 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.


Secondary Outcome Measures :
  1. Day of recovery after sick leave [ Time Frame: From discharge to 12 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.

  2. Diagnose [ Time Frame: From admission (Baseline) to 12 weeks after discharge ]
    Data on patient's diagnosis will be subtracted from the National Patients Registry in relation to ICD-10. This will be used to measure severity of disease.

  3. SuPAR [ Time Frame: From 2 weeks after discharge to 12 weeks after discharge ]
    Soluble urokinase plasminogen activator receptor: Biomarker of low-grade inflammation. SuPAR are measured 2 weeks- and 12 weeks after discharge.

  4. Hand-grip strength of dominant hand [ Time Frame: Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge ]
    Development in isometric handgrip strength from 2 weeks to 12 weeks will be measured in the dominant hand using a handheld dynamometer (Digi-II; Saehan). The patient will be placed in a sitting position in an armchair, with the lower arm placed on the arm rest and an elbow flexion of 90 degrees. The patients will be asked to squeeze the handle as forcefully as possible for 5 secs. Handgrip strength will be expressed in kilograms.

  5. Habitual gait speed [ Time Frame: Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge ]
    Development in physical function from 2 weeks to 12 weeks 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.

  6. Major Depression Inventory (MDI) [ Time Frame: Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge ]
    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).

  7. Health Related Quality of Life (EQ-5D) [ Time Frame: Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge ]
    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. Low health-related quality is defined as below 80 on a scale of 0-100.

  8. Work Ability Index (WAI) [ Time Frame: From Admission (baseline), 2 weeks -, 12 weeks - and 52 weeks after discharge. ]

    Participants are tested for working capacity by answering WAI questionnaire, which in addition to self-assessed work contains parameters regarding self-rated health, marital status, education, smoking, alcohol and exercise.

    Low working capacity will be defined as patients who has; 1) a disease that affects the work capacity, 2) One or more doctor diagnosed diseases or 3) pain in muscles and joints.


  9. Readmission [ Time Frame: From discharge to 52 weeks after discharge ]
    Readmission is measured from the day of discharge to the day the patient is readmitted to a hospital. Data from the National Patients Register kept by the statistics Denmark will be subtracted.

  10. Medication [ Time Frame: From discharge to 12 weeks after discharge ]
    Data on medication use will be subtracted from National Prescription registry kept by Statistics Denmark. This will be used as an explanatory of a possible lack of effect on the primary outcome.

  11. Doctor visits [ Time Frame: From discharge to 52 weeks after discharge ]
    Data on visits to the doctor will be subtracted from register of National Health Insurance kept by Statistics Denmark. This will be used as an explanatory of a possible lack of effect on the primary outcome.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614430


Locations
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Denmark
Clinical research Centre, Amager Hvidovre hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Amager Hospital
Investigators
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Principal Investigator: Ove Andersen, PHD, MD Clinical Research Centre, University Hospital of Copenhagen, Hvidovre

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Responsible Party: Ove Andersen, Research Director, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02614430     History of Changes
Other Study ID Numbers: GA-2015
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Keywords provided by Ove Andersen, Hvidovre University Hospital:
Rehabilitation
Prediction
Inflammation