Chronic Hand Eczema - Self-management and Prognosis
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|ClinicalTrials.gov Identifier: NCT01482663|
Recruitment Status : Completed
First Posted : November 30, 2011
Last Update Posted : December 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hand Eczema Chronic Hand Dermatitis||Behavioral: Healthy Skin Clinic||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||306 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chronic Hand Eczema - Self-management and Prognosis|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||December 2012|
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.
- Hand Eczema Severity Index (HECSI) [ Time Frame: 6 months ]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 ]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 ]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 ]DMARS-4 measured by questionnaire at time = 6 months versus DMARS-4 measured by questionnaire at time = 0 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|