Clinical trial NCT01482663: Chronic Hand Eczema - Self-management and Prognosis
Official title: Chronic Hand Eczema - Self-management and Prognosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hand Eczema
Chronic Hand Dermatitis
Keywords: Hand eczema
Hand dermatitis
Chronic hand eczema
Chronic hand dermatitis
Contact dermatitis
Skin disease
Self-management
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
First posted: 2011-11-30
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Hand Eczema Severity Index (HECSI)
timeFrame: 6 months
Secondary outcomes:
measure: Dermatology Life Quality Index (DLQI)
timeFrame: 6 months
measure: Overall burden of disease (VAS)
timeFrame: 6 months
measure: Danish version of The Medication Adherence Report Scale (DMARS-4)
timeFrame: 6 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Dermatologic practise, Vesterbro 99
city: Hellerup
country: Denmark
facility: Department of Dermato-Allergology, Copenhagen University Hospital Gentofte
Study officials:
affiliation: Copenhagen University Hospital, Gentofte
name: Annette Mollerup, MScHealth
role: PRINCIPAL_INVESTIGATOR
affiliation: Copenhagen University Hospital, Gentofte
name: Jeanne D Johansen, Prof, DMSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.