A 24-week Single-blind Trial of Prevention of Hand Eczema in Cleaners

Study Overview
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Brief Summary
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This study aims to investigate the effectiveness of picture-based prevention education among professional hospital cleaners in relation to hand eczema. This is a single-blinded randomized clinical trial including hospital cleaners at three different hospitals.

Official Title
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Hand Eczema in Cleaners: a Randomized Clinical Trial of Picture-based Prevention Compared to Treatment as Usual Among Professional Hospital Cleaners

Conditions
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Hand Eczema

Intervention / Treatment
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* Behavioral: Change in the incidence of hand eczema
* Behavioral: Change in severity of hand eczema
* Behavioral: Change in the number of self-reported days with absence from work due to having hand eczema
* Behavioral: Change in the number of participants being forced to change their job due to having hand eczema
* Behavioral: Change in The Quality Of Life in in relation to hand eczema
* Behavioral: Change in the level of knowledge regarding skin care and protection.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Professional hospital cleaners ≥ 18 years old Sufficient Danish skills Written informed consent Exclusion Criteria: Insufficient Danish skills Pregnancy Other skin diseases on the hands Receiving Immunomodulatory therapies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A cluster-randomized clinical trial, including three different hospitals. At each hospital, 78 cleaners will be included.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Picture-based prevention education and an educational course<br>The participants will have access to picture-based prevention education, and at the same time, they will participate in an educational course. | Behavioral: Change in the incidence of hand eczema<br>* Assessed by the self-reported cases of newly-developed hand eczema. Change between baseline and 6 months.<br>Behavioral: Change in severity of hand eczema<br>* Assessed by using the Hand Eczema Severity Index (HECSI). HECSI score: 0-360 points (0 best, 360 worst). Change between baseline and 6 months.<br>Behavioral: Change in the number of self-reported days with absence from work due to having hand eczema<br>* Self-reported total number of sick days due to having hand eczema. Change between baseline and 6 months.<br>Behavioral: Change in the number of participants being forced to change their job due to having hand eczema<br>* Self-reported change of job due to having hand eczema. Change between baseline and 6 months.<br>Behavioral: Change in The Quality Of Life in in relation to hand eczema<br>* Assessed by using Hand Eczema Questionnaire (QolHEQ). Change between baseline and 6 months.<br>Behavioral: Change in the level of knowledge regarding skin care and protection.<br>* Self-reported level of knowledge regarding skin care and protection. Change between baseline and 6 months.<br>|
| Experimental: Group 2: Picture-based prevention education only (no educational course)<br>The participants will only have access to picture-based prevention education and will not participate in any educational course. | Behavioral: Change in the incidence of hand eczema<br>* Assessed by the self-reported cases of newly-developed hand eczema. Change between baseline and 6 months.<br>Behavioral: Change in severity of hand eczema<br>* Assessed by using the Hand Eczema Severity Index (HECSI). HECSI score: 0-360 points (0 best, 360 worst). Change between baseline and 6 months.<br>Behavioral: Change in the number of self-reported days with absence from work due to having hand eczema<br>* Self-reported total number of sick days due to having hand eczema. Change between baseline and 6 months.<br>Behavioral: Change in the number of participants being forced to change their job due to having hand eczema<br>* Self-reported change of job due to having hand eczema. Change between baseline and 6 months.<br>Behavioral: Change in The Quality Of Life in in relation to hand eczema<br>* Assessed by using Hand Eczema Questionnaire (QolHEQ). Change between baseline and 6 months.<br>Behavioral: Change in the level of knowledge regarding skin care and protection.<br>* Self-reported level of knowledge regarding skin care and protection. Change between baseline and 6 months.<br>|
| Placebo Comparator: Group 3: Placebo (control)<br>The participants will not have access to picture-based prevention education and do not participate in any educational course. | Behavioral: Change in the incidence of hand eczema<br>* Assessed by the self-reported cases of newly-developed hand eczema. Change between baseline and 6 months.<br>Behavioral: Change in severity of hand eczema<br>* Assessed by using the Hand Eczema Severity Index (HECSI). HECSI score: 0-360 points (0 best, 360 worst). Change between baseline and 6 months.<br>Behavioral: Change in the number of self-reported days with absence from work due to having hand eczema<br>* Self-reported total number of sick days due to having hand eczema. Change between baseline and 6 months.<br>Behavioral: Change in the number of participants being forced to change their job due to having hand eczema<br>* Self-reported change of job due to having hand eczema. Change between baseline and 6 months.<br>Behavioral: Change in The Quality Of Life in in relation to hand eczema<br>* Assessed by using Hand Eczema Questionnaire (QolHEQ). Change between baseline and 6 months.<br>Behavioral: Change in the level of knowledge regarding skin care and protection.<br>* Self-reported level of knowledge regarding skin care and protection. Change between baseline and 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of hand eczema | Measured by a self-reported questionnaire | Change between baseline and 6 months | 
| Hand Eczema Severity Index (HECSI) | Objective assessment of disease severity, measured by HECSI-score: 0-360 points (0 best, 360) worst) | Change between baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of absence from work due to having hand eczema | Measured by a self-reported questionnaire | Change between baseline and 6 months | 
| Rate of participants being forced to change their job due to having hand eczema (questionnaire-based). | Measured by a self-reported questionnaire | Change between baseline and 6 months | 
| The Quality Of Life in Hand Eczema Questionnaire (QqlHEQ) | Subjective assessment of quality of life using QqlHEQ which contains 30 items; generally, all items are scored 0-4 (only three items differ in their scoring structure). | Change between baseline and 6 months | 
| Rate of knowledge regarding skin care and protection. | Measured by a self-reported questionnaire | Change between baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Occupational, Picture, Cleaning