A Randomised Clinical Trial in a Population of Health Care Workers With Hand Eczema (HET)
Primary Purpose
Eczema, Dermatitis, Skin Disease
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
A randomised clinical trial of the effect of classification and individual counselling
Sponsored by
About this trial
This is an interventional prevention trial for Eczema focused on measuring Hand eczema, Hand dermatitis, Occupational skin disease, skindisease in health care workers, occupational hand dermatitis, occupational hand eczema
Eligibility Criteria
Inclusion Criteria:
- Participants will be recruited on the basis of the results from the questionnaire investigation of 3,181 HCW in three Danish hospitals in the same region. Participants who have answered "yes" to the validated question "Have you had hand eczema within the past twelve months?" will be invited to take part in the clinical trial.
- Informed written consent must be present in order to participate.
Exclusion Criteria:
- Pregnancy
- Systemic use of immunosuppressive drugs
- Systemic use of retinoids
- Active psoriatic lesions on the hands
- Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
- Lack of informed written consent
Sites / Locations
- Holbaek Hospital
- Koege Hospital
- Dermatological Department, Roskilde County HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Hand Eczema in health care workers
Arm Description
Outcomes
Primary Outcome Measures
Primary outcome: Objective assessment of disease severity (HE), measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.
Secondary Outcome Measures
Secondary outcomes: -Subjective assessment of disease severity (HE) -Number of eruptions through the past three months -Knowledge of skin protection -Skinprotective behaviour -Quality of life
Full Information
NCT ID
NCT01012453
First Posted
November 12, 2009
Last Updated
November 12, 2009
Sponsor
Zealand University Hospital
Collaborators
The Danish Working Environment Authority, Region Zealand
1. Study Identification
Unique Protocol Identification Number
NCT01012453
Brief Title
A Randomised Clinical Trial in a Population of Health Care Workers With Hand Eczema
Acronym
HET
Official Title
Hand Eczema Trial: A Randomised Clinical Trial of the Effect of Classification and Individual Counselling Among Health Care Workers With Hand Eczema
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Zealand University Hospital
Collaborators
The Danish Working Environment Authority, Region Zealand
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objectives and perspective:
To estimate the prevalence of hand eczema in a cohort of health care workers and assess exposures in the hospital environment that can lead to hand eczema . To investigate the knowledge of skin protection among health care workers.
To classify subtypes of hand eczema, assess severity of hand eczema and quality of life in health care workers with hand eczema
To evaluate the effect of a combination of classification of hand eczema and individual work-related counseling in skin protective behavior.
The overall perspective of the trial is to develop new strategies for prevention of occupational hand eczema in health care workers.
Hypotheses:
Irritant contact dermatitis is more common than allergic contact dermatitis.
The combination of precise classification (subtyping of HE) and individual counseling will have a positive impact on the prognosis of hand eczema.
The positive impact on the prognosis of hand eczema will have a positive impact on quality of life (QoL).
The knowledge of protective behavior will increase.
Education in a skin care program will have a positive impact on skin protective behavior.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema, Dermatitis, Skin Disease
Keywords
Hand eczema, Hand dermatitis, Occupational skin disease, skindisease in health care workers, occupational hand dermatitis, occupational hand eczema
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hand Eczema in health care workers
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
A randomised clinical trial of the effect of classification and individual counselling
Intervention Description
The trial to be conducted is a randomised single-blinded parallel study. It is divided in two stages, T = 0 and follow-up at T = 6 months. All included participants will have a clinical examination at the beginning and at follow-up in the trial. Half of the participants will be randomised to intervention, the other half to control. The participants in the intervention group will, after the first clinical examination, pass on directly to the intervention which includes an allergological examination (patch and prick testing). Three days later they will be examined by a physician who will interpret the patch test and give a thorough, individual guidance in skin protection and occupational safety. The clinical examination of all participants at follow-up will reveal the difference in outcomes in the intervention and the control group.
Primary Outcome Measure Information:
Title
Primary outcome: Objective assessment of disease severity (HE), measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Secondary outcomes: -Subjective assessment of disease severity (HE) -Number of eruptions through the past three months -Knowledge of skin protection -Skinprotective behaviour -Quality of life
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants will be recruited on the basis of the results from the questionnaire investigation of 3,181 HCW in three Danish hospitals in the same region. Participants who have answered "yes" to the validated question "Have you had hand eczema within the past twelve months?" will be invited to take part in the clinical trial.
Informed written consent must be present in order to participate.
Exclusion Criteria:
Pregnancy
Systemic use of immunosuppressive drugs
Systemic use of retinoids
Active psoriatic lesions on the hands
Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
Lack of informed written consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Sophie Ibler, MD, Ph.d-student
Phone
+45-47322600
Email
ksi@regionsjaelland.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Tove Agner, MD, DM Science
Facility Information:
Facility Name
Holbaek Hospital
City
Holbaek
ZIP/Postal Code
4300
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Sophie Ibler, MD, Ph.d-student
Facility Name
Koege Hospital
City
Koege
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
kristina Sophie Ibler, MD, Ph.d-student
Facility Name
Dermatological Department, Roskilde County Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Sophie Ibler, Md, Ph.d-student
12. IPD Sharing Statement
Citations:
PubMed Identifier
23236031
Citation
Ibler KS, Jemec GB, Diepgen TL, Gluud C, Lindschou Hansen J, Winkel P, Thomsen SF, Agner T. Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised clinical trial. BMJ. 2012 Dec 12;345:e7822. doi: 10.1136/bmj.e7822.
Results Reference
derived
PubMed Identifier
20807407
Citation
Ibler KS, Agner T, Hansen JL, Gluud C. The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema. BMC Dermatol. 2010 Aug 31;10:8. doi: 10.1186/1471-5945-10-8.
Results Reference
derived
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A Randomised Clinical Trial in a Population of Health Care Workers With Hand Eczema
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