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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-15101 | Other Identifier | Science Ethics Committee in Greenland |
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| Name | Class |
|---|---|
| LEO Foundation | UNKNOWN |
| University of Copenhagen | OTHER |
| Greenland University | UNKNOWN |
| Government of Greenland, Agency for Health and Prevention |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention programme | Experimental | The participants will have access to a prevention programme. |
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| Control group | No Intervention | The participants will not have access to a prevention programme. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevention programme | Behavioral | The prevention programme consists of a validated educational video and training in the basic recognition and prevention of hand eczema. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in knowledge of hand eczema at 3 months | Knowledge of hand eczema measured by a self-reported questionnaire | From enrollment to the end of intervention at 12 weeks |
| Change from baseline in clinical severity of hand eczema at 3 months | 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. | From enrollment to the end of intervention at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in patient-reported quality of life at 3 months | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Greenland | Ilulissat | Greenland | ||||
| Royal Greenland |
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| UNKNOWN |
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| From enrollment to the end of intervention at 12 weeks |
| Change from baseline in Patient Global Assessment of Disease Severity (PaGA) at 3 months | 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). | From enrollment to the end of intervention at 12 weeks |
| Change from baseline in the number of self-reported days with absence from work due to hand eczema at 3 months | The number of self-reported days with absence from work due to hand eczema measured by a questionnaire-based interview. | From enrollment to the end of intervention at 12 weeks |
| Change from baseline in the number of participants being forced to change their job due to hand eczema at 3 months | The number of participants being forced to change their job due to hand eczema measured by a questionnaire-based interview. | From enrollment to the end of intervention at 12 weeks |
| Change from baseline in the availability of protective equipment at 3 months | The availability of protective equipment (protective gloves, cotton undergloves, moisturisers, and disinfectants) at the workplace measured by a questionnaire-based interview. | From enrollment to the end of intervention at 12 weeks |
| Maniitsoq |
| Greenland |
| Royal Greenland | Qasigiannguit | Greenland |
| Royal Greenland | Sisimiut | Greenland |