Hand Eczema
Conditions
Brief summary
This study aims to investigate the effect of a prevention programme on hand eczema among workers in the Greenlandic fishing industry. This is a non-randomised clinical trial including employees at four of Royal Greenland's fish processing facilities in Greenland.
Interventions
BEHAVIORALPrevention programme
The prevention programme consists of a validated educational video and training in the basic recognition and prevention of hand eczema.
Sponsors
LEO Foundation
University of Copenhagen
Greenland University
Government of Greenland, Agency for Health and Prevention
Bispebjerg Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Employee in Royal Greenland, a state-owned company and one of the largest seafood enterprises in the world * Written informed consent
Exclusion criteria
* Age below 18 years * Inability to understand the Greenlandic, Danish or English language * Pregnancy * Other chronic skin diseases on the hands * Receiving immunomodulatory therapies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in knowledge of hand eczema at 3 months | From enrollment to the end of intervention at 12 weeks | Knowledge of hand eczema measured by a self-reported questionnaire |
| Change from baseline in clinical severity of hand eczema at 3 months | From enrollment to the end of intervention at 12 weeks | Clinical severity of hand eczema measured by Hand Eczema Severity Index (HECSI). The HECSI score ranges from 0 to 360, with higher scores reflecting greater disease severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the number of self-reported days with absence from work due to hand eczema at 3 months | From enrollment to the end of intervention at 12 weeks | The number of self-reported days with absence from work due to hand eczema measured by a questionnaire-based interview. |
| Change from baseline in patient-reported quality of life at 3 months | From enrollment to the end of intervention at 12 weeks | Patient-reported quality of life measured by Hand Eczema Impact Scale (HEIS). The HEIS is a validated 9-item questionnaire that measure the impact of hand eczema on patients' quality of life, based on recall over the past week. Domains include proximal daily activity limitations, embarrassment with the appearance of the hands, frustration with chronic hand eczema, sleep, work, and physical functioning. Each item is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The HEIS score is the average of the 9 items. |
| Change from baseline in the availability of protective equipment at 3 months | From enrollment to the end of intervention at 12 weeks | The availability of protective equipment (protective gloves, cotton undergloves, moisturisers, and disinfectants) at the workplace measured by a questionnaire-based interview. |
| Change from baseline in the number of participants being forced to change their job due to hand eczema at 3 months | From enrollment to the end of intervention at 12 weeks | The number of participants being forced to change their job due to hand eczema measured by a questionnaire-based interview. |
| Change from baseline in Patient Global Assessment of Disease Severity (PaGA) at 3 months | From enrollment to the end of intervention at 12 weeks | The PaGA rates the severity of the patient's global disease assessed by the patient and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
Countries
Greenland
Outcome results
None listed