Chronic Hand Eczema - Self-management and Prognosis
|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|
- 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.
- 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.
|Study Start Date:||May 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482663
|Dermatologic practise, Vesterbro 99|
|Aalborg, Denmark, 9000|
|Department of Dermato-Allergology, Copenhagen University Hospital Gentofte|
|Hellerup, Denmark, 2900|
|Principal Investigator:||Annette Mollerup, MScHealth||Copenhagen University Hospital Gentofte|
|Study Director:||Jeanne D Johansen, Prof, DMSc||Copenhagen University Hospital Gentofte|