A Randomised Clinical Trial on the Effect of Group Education on Patients With Occupational Hand Eczema
PREVEX
1 other identifier
interventional
770
1 country
1
Brief Summary
Occupational hand eczema (OHE) is a frequent disease which often takes a chronic course. The burden of the disease is high in a personal as well as in a socio-economic context. There is a need for evaluating new strategies to improve the prognosis for OHE patients. The objectives of the study is to evaluate the effect of group education on sick lave, health-related quality of life and disease severity among individuals with newly notified OHE. 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. .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 4, 2013
CompletedFirst Posted
Study publicly available on registry
July 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedDecember 2, 2015
November 1, 2015
1.5 years
July 4, 2013
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Sick leave
• Total sick leave; measured as self-reported number of days with sick leave during the trial period.
1 year
Health-related quality of life
Health-related quality of life; measured as points scored in the Dermatology Life Quality Index (DLQI) at 12 months after inclusion. •
1 year
Disease severity
Subjective assessment of hand eczema severity; measured by use of a photographic guide at 12 months after inclusion.
1 year
Secondary Outcomes (1)
eczema-related sick leave
1 year
Study Arms (2)
education in skin care
EXPERIMENTALThe 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
NO INTERVENTIONThe control group will not have access to the group education, the profession specific information and the social guidance or the telephone hotline.
Interventions
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
You may qualify if:
- Self-reported HE, i.e., individuals answering 'yes' in the questionnaire to the question 'Have you or have you had hand eczema?'
- The questionnaire is sufficiently filled in with respect to 'severity of HE' and 'profession'.
- Written informed consent.
You may not qualify if:
- Age below 18 years or above 65 years.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bispebjerg Hospital
Copenhagen, 2400, Denmark
Related Publications (1)
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.
PMID: 24245553DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
July 4, 2013
First Posted
July 15, 2013
Study Start
July 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
December 2, 2015
Record last verified: 2015-11