A Randomised Clinical Trial on the Effect of Group Education on Patients With Occupational Hand Eczema
NCT ID: NCT01899287
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
770 participants
INTERVENTIONAL
2012-07-31
2014-01-31
Brief Summary
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The trial population consist of individuals from the Capital Region of Denmark and Region Zealand with a suspected skin-related industrial injury notified to the Danish National Board of Industrial Injuries (DNBII). Recruitment is started Juli 2012, and will continue until the designed number of participants have been included.
All participants will be assessed in a questionnaire at time T=0 with regard to: self evaluated disease severity, health-related quality of life, skin protective behaviour, knowledge of skin protection, self-efficacy, work-role function and if active in workforce. The participants will then be randomised. The intervention group will be invited to participate in the educative course, and work place visits will be offered. In the intervention group a telephone hot line will be available for further questions concerning these topics. The control group will not have access to any of these interventions. Both intervention group and control group will be contacted every eighth week about number of days of sick leave/absence from workforce. Both groups are re-assessed using a questionnaire at T=12 months. There will be a total of 742 included participants.
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Detailed Description
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* Early information build on evidence-based skin-protection programmes and work-place visits with counselling in skin care, followed by telephone hotline, will give the participants increased level of knowledge concerning the treatment and prevention of OHE.
* Increased level of knowledge concerning prevention and focus on skin care will have a positive impact on skin-protective behaviour and will lower the severity of HE and prevent the development of chronic eczema.
* The decrease in severity of HE will decrease sick leave and keep the participants in job, or prevent job loss, or facilitate the re-entry into the workforce.
* In total, the intervention will have a positive effect on health-related quality of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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education in skin care
The experimental intervention consists of:
A. Group education on general skin-protective behaviour. B. Group education and counselling on work-related skin-protective behaviour, which might extend to a work-place visit.
C. Social guidance related to OHE. D. Telephone hot-line for work and case-related problems, maintained by nurse.
group education
The experimental intervention consists of:
A. Group education on general skin-protective behaviour. B. Group education and counselling on work-related skin-protective behaviour, which might extend to a work-place visit.
C. Social guidance related to OHE. D. Telephone hot-line for work and case-related problems, maintained by nurse.
no intervention
The control group will not have access to the group education, the profession specific information and the social guidance or the telephone hotline.
No interventions assigned to this group
Interventions
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group education
The experimental intervention consists of:
A. Group education on general skin-protective behaviour. B. Group education and counselling on work-related skin-protective behaviour, which might extend to a work-place visit.
C. Social guidance related to OHE. D. Telephone hot-line for work and case-related problems, maintained by nurse.
Eligibility Criteria
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Inclusion Criteria
* The questionnaire is sufficiently filled in with respect to 'severity of HE' and 'profession'.
* Written informed consent.
Exclusion Criteria
* Permanently excluded from the workforce.
* Inability to understand the Danish language sufficiently to benefit from the course.
* Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results.
* Lack of written informed consent.
18 Years
65 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
Responsible Party
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Tove Agner
professor
Locations
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Bispebjerg Hospital
Copenhagen, , Denmark
Countries
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References
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Fisker MH, Agner T, Lindschou J, Bonde JP, Ibler KS, Gluud C, Winkel P, Ebbehoj NE. Protocol for a randomised trial on the effect of group education on skin-protective behaviour versus treatment as usual among individuals with newly notified occupational hand eczema - the Prevention of Hand Eczema (PREVEX) Trial. BMC Dermatol. 2013 Nov 19;13:16. doi: 10.1186/1471-5945-13-16.
Other Identifiers
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H-1-2012-053
Identifier Type: -
Identifier Source: org_study_id