Chronic Hand Eczema - Self-management and Prognosis

December 2, 2014 updated by: Annette Mollerup, University Hospital, Gentofte, Copenhagen
Hand eczema is a common disease which often gives a chronic course thus affecting many functions in daily life. The body of evidence related to self-management of chronic hand eczema is poor. Better methods to support self-management of patients with chronic hand eczema may potentially improve the prognosis of a disease which is both a tremendous burden to the individual and to the society. The purpose of this trial is to evaluate the effect of a newly designed guidance programme offering individual counselling compared to conventional information with written information sheets.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Detailed description of the trial and the intervention can be found in the publication:

Mollerup A, Veien NK, Johansen JD. Chronic hand eczema--self-management and prognosis: a study protocol for a randomised clinical trial'. BMC Dermatol. 2012 Jun 12;12:6. doi: 10.1186/1471-5945-12-6.

PMID: 22691871 [PubMed - indexed for MEDLINE] Free PMC Article

Study Type

Interventional

Enrollment (Actual)

306

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
      • Aalborg, Denmark, 9000
        • Dermatologic practise, Vesterbro 99
      • Hellerup, Denmark, 2900
        • Department of Dermato-Allergology, Copenhagen University Hospital Gentofte

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients clinically diagnosed with hand eczema at the first medical consultation at the outpatient ward, Copenhagen University Hospital Gentofte or at a private dermatologic practise in Aalborg, Denmark
  • Patients who have given a signed informed consent to participate

Exclusion Criteria:

  • Patients who cannot reply to a questionnaire in Danish

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Chronic hand eczema patients
Written information sheets and a 14-minutes DVD about hand eczema handed out by the dermatologist
Experimental: Behavioral: Healthy Skin Clinic
1-2 counselling sessions with a nurse, tailored according to individual risks and resources and user access to a website comprising a self-monitoring log, a patients' forum and the possibility of communication with the intervention team of nurses
Behavioral: Healthy Skin Clinic

The intervention is founded upon three concurrent elements. Firstly, a SKIN-profile generated by data from a baseline questionnaire (S=Susceptibility, K=Competencies, I=Individual characteristics, N=Necessary precautions).

Secondly, a patient self-management book which includes a patient's log and is offered in both an online and a physical form. Also support to self-management is offered through possible asynchronous communication and networking.

Finally, a counselling consultation with a nurse, trained within dermatology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand Eczema Severity Index (HECSI)
Time Frame: 6 months
Objective assessment of disease severity, measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermatology Life Quality Index (DLQI)
Time Frame: 6 months
DLQI measured by questionnaire at time = 6 months versus DLQI measured by questionnaire at time = 0.
6 months
Overall burden of disease (VAS)
Time Frame: 6 months
VAS measured by questionnaire at time = 6 months versus VAS measured by questionnaire at time = 0.
6 months
Danish version of The Medication Adherence Report Scale (DMARS-4)
Time Frame: 6 months
DMARS-4 measured by questionnaire at time = 6 months versus DMARS-4 measured by questionnaire at time = 0 months.
6 months

Collaborators and Investigators

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

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

TrygFonden, Denmark

Investigators

  • Principal Investigator: Annette Mollerup, MScHealth, Copenhagen University hospital, Gentofte
  • Study Director: Jeanne D Johansen, Prof, DMSc, Copenhagen University hospital, Gentofte

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

May 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 23, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (Estimate)

November 30, 2011

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHE-2011-Geh

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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