Chronic Hand Eczema - Self-management and Prognosis

Study Overview
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Brief Summary
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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
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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

Official Title
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Chronic Hand Eczema - Self-management and Prognosis

Conditions
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Chronic Hand Eczema, Chronic Hand Dermatitis

Intervention / Treatment
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* Behavioral: Healthy Skin Clinic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Chronic hand eczema patients<br>Written information sheets and a 14-minutes DVD about hand eczema handed out by the dermatologist | |
| Experimental: Behavioral: Healthy Skin Clinic<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology Life Quality Index (DLQI) | DLQI measured by questionnaire at time = 6 months versus DLQI measured by questionnaire at time = 0. | 6 months | 
| Overall burden of disease (VAS) | 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) | DMARS-4 measured by questionnaire at time = 6 months versus DMARS-4 measured by questionnaire at time = 0 months. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hand eczema, Hand dermatitis, Chronic hand eczema, Chronic hand dermatitis, Contact dermatitis, Skin disease, Self-management