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

Primary Purpose

Hand Eczema

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Change in the incidence of hand eczema

Change in severity of hand eczema

Change in the number of self-reported days with absence from work due to having hand eczema

Change in the number of participants being forced to change their job due to having hand eczema

Change in The Quality Of Life in in relation to hand eczema

Change in the level of knowledge regarding skin care and protection.

About this trial

This is an interventional prevention trial for Hand Eczema focused on measuring Prevention, Occupational, Picture, Cleaning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cleaning departments at Køge, Slagelse and Holbæk hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

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

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

Group 3: Placebo (control)

Arm Description

The participants will have access to picture-based prevention education, and at the same time, they will participate in an educational course.

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

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

Outcomes

Primary Outcome Measures

Incidence rate of hand eczema

Measured by a self-reported questionnaire

Hand Eczema Severity Index (HECSI)

Objective assessment of disease severity, measured by HECSI-score: 0-360 points (0 best, 360) worst)

Secondary Outcome Measures

Rate of absence from work due to having hand eczema

Measured by a self-reported questionnaire

Rate of participants being forced to change their job due to having hand eczema (questionnaire-based).

Measured by a self-reported questionnaire

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).

Rate of knowledge regarding skin care and protection.

Measured by a self-reported questionnaire

Full Information

NCT ID

NCT05763914

First Posted

February 14, 2023

Last Updated

September 9, 2023

Sponsor

Zealand University Hospital

Collaborators

University of Copenhagen, Danish Working Environment Fund

1. Study Identification

Unique Protocol Identification Number

NCT05763914

Brief Title

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

Acronym

HEIC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

November 14, 2022 (Actual)

Primary Completion Date

June 24, 2023 (Actual)

Study Completion Date

June 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zealand University Hospital

Collaborators

University of Copenhagen, Danish Working Environment Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hand Eczema

Keywords

Prevention, Occupational, Picture, Cleaning

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A cluster-randomized clinical trial, including three different hospitals. At each hospital, 78 cleaners will be included.

Masking

Participant

Allocation

Randomized

Enrollment

234 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

The participants will have access to picture-based prevention education, and at the same time, they will participate in an educational course.

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

Group 3: Placebo (control)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Change in the incidence of hand eczema

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Change in severity of hand eczema

Intervention Description

Assessed by using the Hand Eczema Severity Index (HECSI). HECSI score: 0-360 points (0 best, 360 worst). Change between baseline and 6 months.

Intervention Type

Behavioral

Intervention Name(s)

Change in the number of self-reported days with absence from work due to having hand eczema

Intervention Description

Self-reported total number of sick days due to having hand eczema. Change between baseline and 6 months.

Intervention Type

Behavioral

Intervention Name(s)

Change in the number of participants being forced to change their job due to having hand eczema

Intervention Description

Self-reported change of job due to having hand eczema. Change between baseline and 6 months.

Intervention Type

Behavioral

Intervention Name(s)

Change in The Quality Of Life in in relation to hand eczema

Intervention Description

Assessed by using Hand Eczema Questionnaire (QolHEQ). Change between baseline and 6 months.

Intervention Type

Behavioral

Intervention Name(s)

Change in the level of knowledge regarding skin care and protection.

Intervention Description

Self-reported level of knowledge regarding skin care and protection. Change between baseline and 6 months.

Primary Outcome Measure Information:

Title

Incidence rate of hand eczema

Description

Measured by a self-reported questionnaire

Time Frame

Change between baseline and 6 months

Title

Hand Eczema Severity Index (HECSI)

Description

Objective assessment of disease severity, measured by HECSI-score: 0-360 points (0 best, 360) worst)

Time Frame

Change between baseline and 6 months

Secondary Outcome Measure Information:

Title

Rate of absence from work due to having hand eczema

Description

Measured by a self-reported questionnaire

Time Frame

Change between baseline and 6 months

Title

Rate of participants being forced to change their job due to having hand eczema (questionnaire-based).

Description

Measured by a self-reported questionnaire

Time Frame

Change between baseline and 6 months

Title

The Quality Of Life in Hand Eczema Questionnaire (QqlHEQ)

Description

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).

Time Frame

Change between baseline and 6 months

Title

Rate of knowledge regarding skin care and protection.

Description

Measured by a self-reported questionnaire

Time Frame

Change between baseline and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristina Sophie Ibler, M.D.

Organizational Affiliation

Zealand University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleaning departments at Køge, Slagelse and Holbæk hospitals

City

Køge

State/Province

Zealand Region

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

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

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