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

Hand Eczema Clinical Trial

— HEIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05763914
• Other study ID #: 20205100702
• Status: Completed
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: June 24, 2023

Study information

• Verified date: September 2023
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: June 24, 2023
• Est. primary completion date: June 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eczema
• Hand Eczema

Intervention

Behavioral:
• Change in the incidence of hand eczema
Assessed by the self-reported cases of newly-developed hand eczema. Change between baseline and 6 months.
• Change in severity of hand eczema
Assessed by using the Hand Eczema Severity Index (HECSI). HECSI score: 0-360 points (0 best, 360 worst). Change between baseline and 6 months.
• Change in the number of self-reported days with absence from work due to having hand eczema
Self-reported total number of sick days due to having hand eczema. Change between baseline and 6 months.
• Change in the number of participants being forced to change their job due to having hand eczema
Self-reported change of job due to having hand eczema. Change between baseline and 6 months.
• Change in The Quality Of Life in in relation to hand eczema
Assessed by using Hand Eczema Questionnaire (QolHEQ). Change between baseline and 6 months.
• Change in the level of knowledge regarding skin care and protection.
Self-reported level of knowledge regarding skin care and protection. Change between baseline and 6 months.

Locations

Country	Name	City	State
Denmark	Cleaning departments at Køge, Slagelse and Holbæk hospitals	Køge	Zealand Region

Sponsors (3)

Lead Sponsor	Collaborator
Zealand University Hospital	Danish Working Environment Fund, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of hand eczema	Measured by a self-reported questionnaire	Change between baseline and 6 months
Primary	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	Rate of absence from work due to having hand eczema	Measured by a self-reported questionnaire	Change between baseline and 6 months
Secondary	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
Secondary	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
Secondary	Rate of knowledge regarding skin care and protection.	Measured by a self-reported questionnaire	Change between baseline and 6 months