HET: A Randomised Clinical Trial in a Population of Health Care Workers With Hand Eczema

Sponsor

Zealand University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01012453

Collaborator

The Danish Working Environment Authority (Other), Region Zealand (Other)

300

Enrollment

Locations

Arm

100

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Eczema Dermatitis Skin Disease	Behavioral: A randomised clinical trial of the effect of classification and individual counselling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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 :

Oct 1, 2009

Actual Primary Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

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. [6 months]

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 [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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