Chronic Hand Eczema - Self-management and Prognosis

Not Applicable

Completed

• Conditions: Chronic Hand Eczema; Chronic Hand Dermatitis
• Interventions: Behavioral: Healthy Skin Clinic

• Registration Number: NCT01482663
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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.

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-11-23
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-30
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral: Healthy Skin Clinic	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

Primary Outcome Measures

Name	Time	Method
Hand Eczema Severity Index (HECSI)	6 months	Objective assessment of disease severity, measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.

Secondary Outcome Measures

Name	Time	Method
Dermatology Life Quality Index (DLQI)	6 months	DLQI measured by questionnaire at time = 6 months versus DLQI measured by questionnaire at time = 0.
Overall burden of disease (VAS)	6 months	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)	6 months	DMARS-4 measured by questionnaire at time = 6 months versus DMARS-4 measured by questionnaire at time = 0 months.

Trial Locations

Locations (2)

Dermatologic practise, Vesterbro 99; 🇩🇰 Aalborg, Denmark

Department of Dermato-Allergology, Copenhagen University Hospital Gentofte; 🇩🇰 Hellerup, Denmark