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

Not Applicable

Completed

• Conditions: Hand Eczema

• 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

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