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

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

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.

Study Overview

• Status: Completed
• Conditions: Hand Eczema
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Zealand Region
    • Køge, Zealand Region, Denmark
      • Cleaning departments at Køge, Slagelse and Holbæk hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Picture-based prevention education and an educational course; 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; Assessed by the self-reported cases of newly-developed hand eczema. Change between baseline and 6 months.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.
Experimental: Group 2: Picture-based prevention education only (no educational course); 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; Assessed by the self-reported cases of newly-developed hand eczema. Change between baseline and 6 months.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.
Placebo Comparator: Group 3: Placebo (control); 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; Assessed by the self-reported cases of newly-developed hand eczema. Change between baseline and 6 months.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: University of Copenhagen; Danish Working Environment Fund
• Investigators: Principal Investigator: Kristina Sophie Ibler, M.D., Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Actual): June 24, 2023
• Study Completion (Actual): June 24, 2023

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 9, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Prevention; Occupational; Picture; Cleaning
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: 20205100702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The results of the project will be shared with other researchers.
• IPD Sharing Time Frame: Materials will be made available six months after the publication of the primary outcomes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No