Chronic Hand Eczema - Self-management and Prognosis

This study has been completed.
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by (Responsible Party):
Annette Mollerup, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01482663
First received: November 23, 2011
Last updated: December 2, 2014
Last verified: December 2014
  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:


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.


Enrollment: 306
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

  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
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: NCT01482663

Locations
Denmark
Dermatologic practise, Vesterbro 99
Aalborg, Denmark, 9000
Department of Dermato-Allergology, Copenhagen University Hospital Gentofte
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
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

Publications:
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: December 2, 2014
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 21, 2015