Chronic Hand Eczema - Self-management and Prognosis

NCT01482663 | Completed

• 1 other identifier: CHE-2011-Geh
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Hand Eczema; Chronic Hand Dermatitis

Keywords

Hand eczema; Hand dermatitis; Chronic hand eczema; Chronic hand dermatitis; Contact dermatitis; Skin disease; Self-management

Outcome Measures

Primary Outcomes (1)

• Hand Eczema Severity Index (HECSI)

  Objective assessment of disease severity, measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.

  6 months

Secondary Outcomes (3)

• Dermatology Life Quality Index (DLQI)

  6 months

• Overall burden of disease (VAS)

  6 months

• Danish version of The Medication Adherence Report Scale (DMARS-4)

  6 months

Study Arms (2)

Chronic hand eczema patients

NO INTERVENTION

Written information sheets and a 14-minutes DVD about hand eczema handed out by the dermatologist

Behavioral: Healthy Skin Clinic

EXPERIMENTAL

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

Interventions

Healthy Skin Clinic BEHAVIORAL

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.

Behavioral: Healthy Skin Clinic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who cannot reply to a questionnaire in Danish

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• TrygFonden, Denmark: collaborator

Study Sites (2)

Dermatologic practise, Vesterbro 99

Aalborg, 9000, Denmark

Location

Department of Dermato-Allergology, Copenhagen University Hospital Gentofte

Hellerup, 2900, Denmark

Location

Related Publications (3)

• Mollerup A, Veien NK, Johansen JD. Effectiveness of the Healthy Skin Clinic--a randomized clinical trial of nurse-led patient counselling in hand eczema. Contact Dermatitis. 2014 Oct;71(4):202-14. doi: 10.1111/cod.12243. Epub 2014 Apr 25.

  PMID: 24766387 RESULT

• Mollerup A, Veien NK, Johansen JD. An analysis of gender differences in patients with hand eczema - everyday exposures, severity, and consequences. Contact Dermatitis. 2014 Jul;71(1):21-30. doi: 10.1111/cod.12206. Epub 2014 Mar 12.

  PMID: 24618009 RESULT

• 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 DERIVED

MeSH Terms

Conditions

Dermatitis, Contact; Skin Diseases

Condition Hierarchy (Ancestors)

Dermatitis; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Annette Mollerup, MScHealth

  University Hospital, Gentofte, Copenhagen

  PRINCIPAL INVESTIGATOR

• Jeanne D Johansen, Prof, DMSc

  University Hospital, Gentofte, Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MScHealth, PhD-student

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: November 30, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

DK (2)