Trial record 7 of 48 for:    Open Studies | "Eczema"

A Randomised Clinical Trial on the Effect of Group Education on Patients With Occupational Hand Eczema (PREVEX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Copenhagen
Sponsor:
Collaborator:
The Copenhagen Trial Unit, Copenhagen University Hospital
Information provided by (Responsible Party):
Tove Agner, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01899287
First received: July 4, 2013
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.

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Condition Intervention
Eczema
Skin Conditions
Behavioral: group education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised Clinical Trial on the Effect of Group Education on Skin-protective Behaviour Versus Treatment as Usual Among Individuals With Newly Notified Occupational Hand Eczema

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Sick leave [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • Total sick leave; measured as self-reported number of days with sick leave during the trial period.

  • Health-related quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Health-related quality of life; measured as points scored in the Dermatology Life Quality Index (DLQI) at 12 months after inclusion.


  • Disease severity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Subjective assessment of hand eczema severity; measured by use of a photographic guide at 12 months after inclusion.


Secondary Outcome Measures:
  • eczema-related sick leave [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    The following outcomes will be assessed as explorative, as there is insufficient information to conduct power calculations.

    • Eczema-related sick leave; measured as self-reported number of days with eczema-related sick leave during the trial period.
    • Absence registered by the DREAM-register; only absence for more than 28 days from workplace is registered here. This will be done at T=12 months. We will measure absence from work because of sick leave for more than 21 days , yes or no.
    • Behaviour measured as number of points achieved in a questionnaire concerning both occupational and private risk behaviour at time T=12.
    • Knowledge of skin protection measured as numbers of points achieved in a multiple choice questionnaire at time T=12 months.
    • Performance management at time T=12 months of the participant measured by the number of points achieved in:

      • Self-efficacy; and
      • Self-evaluated ability to self-care.


Estimated Enrollment: 742
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Behavioral: 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: 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.

Detailed Description:

The hypotheses of the PREVEX trial are:

  • 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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899287

Locations
Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Tove Agner, DMSc    +45 35313486    tove.agner@regionh.dk   
Contact: Niels Ebbehøj, DMSc    +45 35313531      
Principal Investigator: niels ebbehøj, DMSc         
Sponsors and Collaborators
University of Copenhagen
The Copenhagen Trial Unit, Copenhagen University Hospital
  More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tove Agner, professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01899287     History of Changes
Other Study ID Numbers: H-1-2012-053
Study First Received: July 4, 2013
Last Updated: July 10, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Copenhagen:
workers education
occupational

Additional relevant MeSH terms:
Eczema
Skin Diseases
Dermatitis
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on July 22, 2014