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Chronic Hand Eczema - Self-management and Prognosis

This study is currently recruiting participants.
Verified November 2011 by University Hospital, Gentofte, Copenhagen
Sponsor:
Collaborators:
National Allergy Research Centre, Denmark
TrygFonden, Denmark
Information provided by (Responsible Party):
Annette Mollerup, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01482663
First received: November 23, 2011
Last updated: November 28, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Chronic Hand Eczema
Chronic Hand Dermatitis
 Behavioral: Healthy Skin Clinic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Chronic Hand Eczema - Self-management and Prognosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Hand Eczema Severity Index (HECSI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Objective assessment of disease severity, measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.


Secondary Outcome Measures:
  • Dermatology Life Quality Index (DLQI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    DLQI measured by questionnaire at time = 6 months versus DLQI measured by questionnaire at time = 0.

  • Overall burden of disease (VAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    VAS measured by questionnaire at time = 6 months versus VAS measured by questionnaire at time = 0.

  • Danish version of The Medication Adherence Report Scale (DMARS-4) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    DMARS-4 measured by questionnaire at time = 6 months versus DMARS-4 measured by questionnaire at time = 0 months.

  • Number of eruptions through the last six months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Chronic hand eczema patients
Experimental: Behavioral: Healthy Skin Clinic 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482663

Contacts
Contact: Annette Mollerup, MScHealth +45 39777302 amol0005@geh.regionh.dk
Contact: Jeanne D Johansen, Prof, DMSc +45 39777300 jedu@geh.regionh.dk

Locations
Denmark
Dermatologic practise, Vesterbro 99 Recruiting
Aalborg, Denmark, 9000
Contact: Annette Mollerup, MScHealth            
Principal Investigator: Annette Mollerup, MScHealth            
Department of Dermato-Allergology, Copenhagen University Hospital Gentofte Recruiting
Hellerup, Denmark, 2900
Principal Investigator: Annette Mollerup, MScHealth            
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
National Allergy Research Centre, Denmark
TrygFonden, Denmark
Investigators
Principal Investigator: Annette Mollerup, MScHealth Copenhagen University Hospital Gentofte
Study Director: Jeanne D Johansen, Prof, DMSc Copenhagen University Hospital Gentofte
  More Information

No publications provided by University Hospital, Gentofte, Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Annette Mollerup, MScHealth, PhD-student, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01482663     History of Changes
Other Study ID Numbers: CHE-2011-Geh
Study First Received: November 23, 2011
Last Updated: November 28, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University Hospital, Gentofte, Copenhagen:
Hand eczema
Hand dermatitis
Chronic hand eczema
Chronic hand dermatitis
 Contact dermatitis
Skin disease
Self-management

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

ClinicalTrials.gov processed this record on May 19, 2013