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

NCT ID: NCT01012453

Last Updated: 2009-11-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31

Brief Summary

Objectives and perspective:

1. 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.

2. To classify subtypes of hand eczema, assess severity of hand eczema and quality of life in health care workers with hand eczema

3. 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.

Conditions

Eczema; Dermatitis; Skin Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Hand Eczema in health care workers

Group Type: NO_INTERVENTION

A randomised clinical trial of the effect of classification and individual counselling

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Danish Working Environment Authority

UNKNOWN

Sponsor Role: collaborator

Region Zealand

OTHER

Sponsor Role: collaborator

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dermatological Department, Roskilde County Hospital

Locations

Holbaek Hospital

Holbæk, , Denmark

Site Status: NOT_YET_RECRUITING

Koege Hospital

Koege, , Denmark

Site Status: NOT_YET_RECRUITING

Dermatological Department, Roskilde County Hospital

Roskilde, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Kristina Sophie Ibler, MD, Ph.d-student

Role: CONTACT

ksi@regionsjaelland.dk

+45-47322600

Tove Agner, MD, DM Science

Role: CONTACT

References

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.

Reference Type: DERIVED

PMID: 23236031 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20807407 (View on PubMed)

Other Identifiers

SJ-126

Identifier Type: -

Identifier Source: org_study_id