A Randomised Clinical Trial in a Population of Health Care Workers With Hand Eczema (HET)
|ClinicalTrials.gov Identifier: NCT01012453|
Recruitment Status : Unknown
Verified November 2009 by Zealand University Hospital.
Recruitment status was: Recruiting
First Posted : November 13, 2009
Last Update Posted : November 13, 2009
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.
- 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.
|Condition or disease||Intervention/treatment|
|Eczema Dermatitis Skin Disease||Behavioral: A randomised clinical trial of the effect of classification and individual counselling|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||October 2009|
|Primary Completion Date :||October 2009|
|No Intervention: Hand Eczema in health care workers||
Behavioral: A randomised clinical trial of the effect of classification and individual counselling
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: 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 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012453
|Contact: Kristina Sophie Ibler, MD, Ph.firstname.lastname@example.org|
|Contact: Tove Agner, MD, DM Science|
|Holbaek Hospital||Not yet recruiting|
|Holbaek, Denmark, 4300|
|Principal Investigator: Kristina Sophie Ibler, MD, Ph.d-student|
|Koege Hospital||Not yet recruiting|
|Koege, Denmark, 4600|
|Principal Investigator: kristina Sophie Ibler, MD, Ph.d-student|
|Dermatological Department, Roskilde County Hospital||Recruiting|
|Roskilde, Denmark, 4000|
|Principal Investigator: Kristina Sophie Ibler, Md, Ph.d-student|