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Hand EczemaHEICNCT05763914

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

A study testing Change in the incidence of hand eczema, Change in severity of hand eczema and Change in the number of self-reported days with absence from work due to having hand eczema in people with Hand Eczema, run by Zealand University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hand Eczema
What is being tested?
Change in the incidence of hand eczema, Change in severity of hand eczema and Change in the number of self-reported days with absence from work due to having hand eczema
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
234 participants
Where
1 siteDenmark
Study dates
14 Nov 2022to 24 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Professional hospital cleaners ≥ 18 years old
  • Sufficient Danish skills
  • Written informed consent

Who cannot join

  • Insufficient Danish skills
  • Pregnancy
  • Other skin diseases on the hands
  • Receiving Immunomodulatory therapies

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Cleaning departments at Køge, Slagelse and Holbæk hospitals

    Køge, Region Sjælland

Other trials in Denmark

About this study

Official title: 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.

Conditions
Hand Eczema
Being tested
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
Keywords
Prevention, Occupational, Picture, Cleaning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Change in the incidence of hand eczemaBehavioural

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

  • Change in severity of hand eczemaBehavioural

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

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

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

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

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

  • Change in The Quality Of Life in in relation to hand eczemaBehavioural

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

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

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

Study groups in NCT05763914
Study groupRoleWhat they receive
Group 1: Picture-based prevention education and an educational courseExperimentalThe participants will have access to picture-based prevention education, and at the same time, they will participate in an educational course.
Receives: 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.
Group 2: Picture-based prevention education only (no educational course)ExperimentalThe participants will only have access to picture-based prevention education and will not participate in any educational course.
Receives: 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.
Group 3: Placebo (control)Placebo comparatorThe participants will not have access to picture-based prevention education and do not participate in any educational course.
Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of hand eczema

    Measured by a self-reported questionnaire

    Measured: Change between baseline and 6 months

  2. Hand Eczema Severity Index (HECSI)

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

    Measured: Change between baseline and 6 months

Secondary outcomes (4)

  1. Rate of absence from work due to having hand eczema

    Measured by a self-reported questionnaire

    Measured: Change between baseline and 6 months

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

    Measured by a self-reported questionnaire

    Measured: Change between baseline and 6 months

  3. 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).

    Measured: Change between baseline and 6 months

  4. Rate of knowledge regarding skin care and protection.

    Measured by a self-reported questionnaire

    Measured: Change between baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2023
  2. Study start14 Nov 2022
  3. Primary completion24 Jun 2023
  4. Study completion24 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A cluster-randomized clinical trial, including three different hospitals. At each hospital, 78 cleaners will be included.
Masking
Single blind
Who is masked
Participant
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05763914
Sponsor's protocol ID
20205100702
Acronym
HEIC
Status last verified
Sep 2023
First submitted
14 Feb 2023
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The results of the project will be shared with other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Change in the incidence of hand eczema, Change in severity of hand eczema and Change in the number of self-reported days with absence from work due to having hand eczema in people with Hand Eczema, run by Zealand University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of hand eczema (time frame: Change between baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05763914.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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