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Prevention of Hand Eczema Among Workers in the Fishing Industry in Greenland

Not Applicable
Recruiting
Conditions
Hand Eczema
Registration Number
NCT06997393
Lead Sponsor
Bispebjerg Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
70
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change from baseline in knowledge of hand eczema at 3 monthsFrom 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 monthsFrom 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 Outcome Measures
NameTimeMethod
Change from baseline in patient-reported quality of life at 3 monthsFrom 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 Patient Global Assessment of Disease Severity (PaGA) at 3 monthsFrom 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).

Change from baseline in the number of self-reported days with absence from work due to hand eczema at 3 monthsFrom 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 the number of participants being forced to change their job due to hand eczema at 3 monthsFrom 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 the availability of protective equipment at 3 monthsFrom 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.

Trial Locations

Locations (1)

Royal Greenland

🇬🇱

Sisimiut, Greenland

Royal Greenland
🇬🇱Sisimiut, Greenland
Mathilde Tuborg Andersen, MD
Contact
+4538636173
mathilde.tuborg.andersen@regionh.dk

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