Specific Work InhibitionNCT02614430
Recover Working Life - Back on the Job After Acute Illness
A study testing Vocational training in people with Specific Work Inhibition, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Specific Work Inhibition
- What is being tested?
- Vocational training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patients unable to cooperate
- Patients with end-stage disease
- Patients with major trauma
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Clinical research Centre, Amager Hvidovre hospital
Hvidovre, 2650
About this study
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
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.
Read the 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.
- Conditions
- Specific Work Inhibition
- Being tested
- Vocational training
- Keywords
- Rehabilitation, Prediction, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocational trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Vocational training |
| Control | No intervention | Participants are randomized into the control group where they are offered the standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day of recovery after sick leave
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.
Measured: From discharge to 52 weeks after discharge
Secondary outcomes (11)
Day of recovery after sick leave
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.
Measured: From discharge to 12 weeks after discharge
Diagnose
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.
Measured: From admission (Baseline) to 12 weeks after discharge
SuPAR
Soluble urokinase plasminogen activator receptor: Biomarker of low-grade inflammation. SuPAR are measured 2 weeks- and 12 weeks after discharge.
Measured: From 2 weeks after discharge to 12 weeks after discharge
Hand-grip strength of dominant hand
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.
Measured: Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge
Habitual gait speed
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.
Measured: Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge
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).
Measured: Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge
Health Related Quality of Life (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. Low health-related quality is defined as below 80 on a scale of 0-100.
Measured: Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge
Work Ability Index (WAI)
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.
Measured: From Admission (baseline), 2 weeks -, 12 weeks - and 52 weeks after discharge.
Readmission
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.
Measured: From discharge to 52 weeks after discharge
Medication
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.
Measured: From discharge to 12 weeks after discharge
Doctor visits
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.
Measured: From discharge to 52 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startSep 2015
- Primary completion1 May 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific Work InhibitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amager Hospital
- Responsible party
- Principal investigator, Ove Andersen, Hvidovre University Hospital
- Investigators
- Ove Andersen, PHD, MD, Principal investigator, Clinical Research Centre, University Hospital of Copenhagen, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614430
- Sponsor's protocol ID
- GA-2015
- Status last verified
- Sep 2017
- First submitted
- 9 Oct 2015
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02614430
- Acronym / sponsor ID
- GA-2015
- Conditions
- Specific Work Inhibition
- Keywords
- Rehabilitation, Prediction, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Amager Hospital
- Study start
- Sep 2015
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vocational training | Active comparator | Other: Vocational trainingParticipants 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. |
| Control | No intervention | –Participants are randomized into the control group where they are offered the standard treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients unable to cooperate
- Patients with end-stage disease
- Patients with major trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vocational trainingThe 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. | Other | Vocational training |
Primary outcome
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.
11 secondary outcomes
Day of recovery after sick leave
Time frame: From discharge to 12 weeks after discharge
Diagnose
Time frame: From admission (Baseline) to 12 weeks after discharge
SuPAR
Time frame: From 2 weeks after discharge to 12 weeks after discharge
Hand-grip strength of dominant hand
Time frame: Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge
Habitual gait speed
Time frame: Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge
Major Depression Inventory (MDI)
Time frame: Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge
Health Related Quality of Life (EQ-5D)
Time frame: Admission (Baseline), 2 weeks after discharge and 12 weeks after discharge
Work Ability Index (WAI)
Time frame: From Admission (baseline), 2 weeks -, 12 weeks - and 52 weeks after discharge.
Readmission
Time frame: From discharge to 52 weeks after discharge
Medication
Time frame: From discharge to 12 weeks after discharge
Doctor visits
Time frame: From discharge to 52 weeks after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ove Andersen, PHD, MD principal investigator
Clinical Research Centre, University Hospital of Copenhagen, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vocational training in people with Specific Work Inhibition, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day of recovery after sick leave (time frame: From discharge to 52 weeks after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.