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

September 9, 2023 updated by: Farnam Barati Sedeh, Zealand University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
234

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence rate of hand eczema
Time Frame: Change between baseline and 6 months
Measured by a self-reported questionnaire
Change between baseline and 6 months
Hand Eczema Severity Index (HECSI)
Time Frame: Change between baseline and 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of absence from work due to having hand eczema
Time Frame: Change between baseline and 6 months
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).
Time Frame: Change between baseline and 6 months
Measured by a self-reported questionnaire
Change between baseline and 6 months
The Quality Of Life in Hand Eczema Questionnaire (QqlHEQ)
Time Frame: 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).
Change between baseline and 6 months
Rate of knowledge regarding skin care and protection.
Time Frame: Change between baseline and 6 months
Measured by a self-reported questionnaire
Change between baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zealand University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen
Danish Working Environment Fund

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristina Sophie Ibler, M.D., Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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