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Chronic Hand Eczema - Self-management and Prognosis

Chronic Hand Eczema - Self-management and Prognosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01482663
Enrollment
306
Registered
2011-11-30
Start date
2011-05-31
Completion date
2012-12-31
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hand Dermatitis, Chronic Hand Eczema

Keywords

Hand eczema, Hand dermatitis, Chronic hand eczema, Chronic hand dermatitis, Contact dermatitis, Skin disease, Self-management

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

Interventions

BEHAVIORALHealthy 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.

Sponsors

TrygFonden, Denmark
CollaboratorINDUSTRY
University Hospital, Gentofte, Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hand Eczema Severity Index (HECSI)6 monthsObjective assessment of disease severity, measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.

Secondary

MeasureTime frameDescription
Dermatology Life Quality Index (DLQI)6 monthsDLQI measured by questionnaire at time = 6 months versus DLQI measured by questionnaire at time = 0.
Overall burden of disease (VAS)6 monthsVAS 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 monthsDMARS-4 measured by questionnaire at time = 6 months versus DMARS-4 measured by questionnaire at time = 0 months.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026