Chronic Hand Eczema - Self-management and Prognosis

Chronic Hand Eczema Clinical Trial

Official title:

Chronic Hand Eczema - Self-management and Prognosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482663
• Other study ID #: CHE-2011-Geh
• Status: Completed
• Phase: N/A
• First received: November 23, 2011
• Last updated: December 2, 2014
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Hand Dermatitis
• Chronic Hand Eczema
• Dermatitis
• Eczema

Intervention

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.

Locations

Country	Name	City	State
Denmark	Dermatologic practise, Vesterbro 99	Aalborg
Denmark	Department of Dermato-Allergology, Copenhagen University Hospital Gentofte	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Dermatology Life Quality Index (DLQI)	DLQI measured by questionnaire at time = 6 months versus DLQI measured by questionnaire at time = 0.	6 months	No
Secondary	Overall burden of disease (VAS)	VAS measured by questionnaire at time = 6 months versus VAS measured by questionnaire at time = 0.	6 months	No
Secondary	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	No