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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

234

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7 months study duration

Study Start

First participant enrolled

November 14, 2022

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed

24 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2023

Completed

Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

February 14, 2023

Last Update Submit

September 9, 2023

Conditions

Hand Eczema

Keywords

PreventionOccupationalPictureCleaning

Outcome Measures

Primary Outcomes (2)

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 Outcomes (4)

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

Study Arms (3)

Group 1: Picture-based prevention education and an educational course

EXPERIMENTAL

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 eczemaBehavioral: Change in severity of hand eczemaBehavioral: Change in the number of self-reported days with absence from work due to having hand eczemaBehavioral: Change in the number of participants being forced to change their job due to having hand eczemaBehavioral: Change in The Quality Of Life in in relation to hand eczemaBehavioral: Change in the level of knowledge regarding skin care and protection.

Group 2: Picture-based prevention education only (no educational course)

EXPERIMENTAL

The participants will only have access to picture-based prevention education and will not participate in any educational course.

Group 3: Placebo (control)

PLACEBO COMPARATOR

The participants will not have access to picture-based prevention education and do not participate in any educational course.

Interventions

Change in the incidence of hand eczemaBEHAVIORAL

Assessed by the self-reported cases of newly-developed hand eczema. Change between baseline and 6 months.