HOPE: A 24-week Single-blind Trial of Prevention of Hand Eczema in Professional Hospital Cleaners

• Sponsor: Zealand University Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05763914
• Collaborator: University of Copenhagen (Other), Danish Working Environment Fund (Other)
• Enrollment: 219
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 10.6
• Patients Per Site Per Month: 20.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hand Eczema	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.	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 219 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A cluster-randomized clinical trial, including three different hospitals. At each hospital, 73 cleaners will be included.A cluster-randomized clinical trial, including three different hospitals. At each hospital, 73 cleaners will be included.
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: The Hand Eczema Occupation and Prevention -: a Randomized Clinical Trial of Picture-based Prevention Among Professional Hospital Cleaners
• Actual Study Start Date: Dec 5, 2022
• Anticipated Primary Completion Date: Jun 24, 2023
• Anticipated Study Completion Date: Oct 24, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Incidence rate of hand eczema [Change between baseline and 6 months]

   Measured by a self-reported questionnaire

2. 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

1. Rate of absence from work due to having hand eczema [Change between baseline and 6 months]

   Measured by a self-reported questionnaire

2. 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

3. 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).

4. Rate of knowledge regarding skin care and protection. [Change between baseline and 6 months]

   Measured by a self-reported questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleaning departments at Køge	Køge	Zealand Region	Denmark

Sponsors and Collaborators

• Zealand University Hospital
• University of Copenhagen
• Danish Working Environment Fund

Investigators

• Principal Investigator: Kristina Sophie Ibler, M.D., Zealand University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Farnam Barati Sedeh, Principal Investigator, Zealand University Hospital
• ClinicalTrials.gov Identifier: NCT05763914
• Other Study ID Numbers: 20205100702
• First Posted: Mar 10, 2023
• Last Update Posted: Mar 10, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Farnam Barati Sedeh, Principal Investigator, Zealand University Hospital: Prevention; Occupational; Picture; Cleaning
• Additional relevant MeSH terms: Eczema

Study Results

No Results Posted as of Mar 10, 2023