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

November 30, 2015 updated by: Tove Agner, University of Copenhagen

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

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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Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

770

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sick leave
Time Frame: 1 year
• Total sick leave; measured as self-reported number of days with sick leave during the trial period.
1 year
Health-related quality of life
Time Frame: 1 year

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
Time Frame: 1 year
Subjective assessment of hand eczema severity; measured by use of a photographic guide at 12 months after inclusion.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eczema-related sick leave
Time Frame: 1 year

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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 15, 2013

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2012-053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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