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Completed

NCT Number: NCT05763914

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

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Key information

Conditions

Hand Eczema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleaning departments at Køge, Slagelse and Holbæk hospitals

Køge, Region Sjælland, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Change in the incidence of hand eczema

Behavioral

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

Change in severity of hand eczema

Behavioral

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 eczema

Behavioral

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 eczema

Behavioral

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 eczema

Behavioral

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

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

Behavioral

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

Primary outcomes

  1. Incidence rate of hand eczema

    Time frame: Change between baseline and 6 months

    Measured by a self-reported questionnaire

  2. 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)

Secondary outcomes

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

    Time frame: 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).

    Time frame: Change between baseline and 6 months

    Measured by a self-reported questionnaire

  3. 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).

  4. Rate of knowledge regarding skin care and protection.

    Time frame: Change between baseline and 6 months

    Measured by a self-reported questionnaire

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • Danish Working Environment Fund
  • University of Copenhagen

Registry information

Official study title

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

Acronym: HEIC

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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