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EczemaPREVEXNCT01899287

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

A study testing group education in people with Eczema and Skin Conditions, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Eczema, Skin Conditions
What is being tested?
group education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
770 participants
Where
1 siteDenmark
Study dates
Jul 2012to Jan 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Bispebjerg Hospital

    Copenhagen, 2400

Other trials in Denmark

About this study

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

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.

Read more

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.

.

Read the 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.
Being tested
group education
Keywords
workers education, occupational
Medical subject headings
Eczema, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • group educationBehavioural

    The experimental intervention consists of:

    1. 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.
    2. Social guidance related to OHE. D. Telephone hot-line for work and case-related problems, maintained by nurse.
Study groups in NCT01899287
Study groupRoleWhat they receive
education in skin careExperimentalThe 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.
Receives: Behavioral: group education
no interventionNo interventionThe control group will not have access to the group education, the profession specific information and the social guidance or the telephone hotline.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sick leave

    • Total sick leave; measured as self-reported number of days with sick leave during the trial period.

    Measured: 1 year

  2. 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.

    •

    Measured: 1 year

  3. Disease severity

    Subjective assessment of hand eczema severity; measured by use of a photographic guide at 12 months after inclusion.

    Measured: 1 year

Secondary outcomes (1)

  1. eczema-related sick leave

    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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2013 (estimated)
  2. Study startJul 2012
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
770 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01899287
Sponsor's protocol ID
H-1-2012-053
Acronym
PREVEX
Status last verified
Nov 2015
First submitted
4 Jul 2013
Last updated
2 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24245553

Questions about this trial

What is this clinical trial studying?

A study testing group education in people with Eczema and Skin Conditions, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sick leave (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01899287, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.

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