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

Not Applicable

Completed

• Conditions: Hand Eczema
• Interventions: 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.

• Registration Number: NCT05763914
• Lead Sponsor: Zealand University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-14
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-10
• Primary Completion: 2023-06-24
• Study Completion: 2023-06-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-09
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3: Placebo (control)	Change in the incidence of hand eczema	The participants will not have access to picture-based prevention education and do not participate in any educational course.
Group 1: Picture-based prevention education and an educational course	Change in the number of participants being forced to change their job due to having hand eczema	The participants will have access to picture-based prevention education, and at the same time, they will participate in an educational course.
Group 3: Placebo (control)	Change in the number of participants being forced to change their job due to having hand eczema	The participants will not have access to picture-based prevention education and do not participate in any educational course.
Group 1: Picture-based prevention education and an educational course	Change in The Quality Of Life in in relation to hand eczema	The participants will have access to picture-based prevention education, and at the same time, they will participate in an educational course.
Group 2: Picture-based prevention education only (no educational course)	Change in The Quality Of Life in in relation to hand eczema	The participants will only have access to picture-based prevention education and will not participate in any educational course.
Group 1: Picture-based prevention education and an educational course	Change in the incidence of hand eczema	The participants will have access to picture-based prevention education, and at the same time, they will participate in an educational course.
Group 2: Picture-based prevention education only (no educational course)	Change in the level of knowledge regarding skin care and protection.	The participants will only have access to picture-based prevention education and will not participate in any educational course.
Group 3: Placebo (control)	Change in the level of knowledge regarding skin care and protection.	The participants will not have access to picture-based prevention education and do not participate in any educational course.
Group 2: Picture-based prevention education only (no educational course)	Change in severity of hand eczema	The participants will only have access to picture-based prevention education and will not participate in any educational course.
Group 2: Picture-based prevention education only (no educational course)	Change in the number of self-reported days with absence from work due to having hand eczema	The participants will only have access to picture-based prevention education and will not participate in any educational course.
Group 3: Placebo (control)	Change in the number of self-reported days with absence from work due to having hand eczema	The participants will not have access to picture-based prevention education and do not participate in any educational course.
Group 3: Placebo (control)	Change in The Quality Of Life in in relation to hand eczema	The participants will not have access to picture-based prevention education and do not participate in any educational course.
Group 1: Picture-based prevention education and an educational course	Change in severity of hand eczema	The participants will have access to picture-based prevention education, and at the same time, they will participate in an educational course.
Group 1: Picture-based prevention education and an educational course	Change in the number of self-reported days with absence from work due to having hand eczema	The participants will have access to picture-based prevention education, and at the same time, they will participate in an educational course.
Group 1: Picture-based prevention education and an educational course	Change in the level of knowledge regarding skin care and protection.	The participants will have access to picture-based prevention education, and at the same time, they will participate in an educational course.
Group 2: Picture-based prevention education only (no educational course)	Change in the incidence of hand eczema	The participants will only have access to picture-based prevention education and will not participate in any educational course.
Group 2: Picture-based prevention education only (no educational course)	Change in the number of participants being forced to change their job due to having hand eczema	The participants will only have access to picture-based prevention education and will not participate in any educational course.
Group 3: Placebo (control)	Change in severity of hand eczema	The participants will not have access to picture-based prevention education and do not participate in any educational course.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of participants being forced to change their job due to having hand eczema (questionnaire-based).	Change between baseline and 6 months	Measured by a self-reported questionnaire
Rate of absence from work due to having hand eczema	Change between baseline and 6 months	Measured by a self-reported questionnaire
The Quality Of Life in Hand Eczema Questionnaire (QqlHEQ)	Change between baseline and 6 months	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).
Rate of knowledge regarding skin care and protection.	Change between baseline and 6 months	Measured by a self-reported questionnaire

Trial Locations

Locations (1)

Cleaning departments at Køge, Slagelse and Holbæk hospitals; 🇩🇰 Køge, Zealand Region, Denmark