Chronic Hand Eczema - Self-management and Prognosis - Full Text View

Purpose

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.

Condition	Intervention
Chronic Hand Eczema Chronic Hand Dermatitis	Behavioral: Healthy Skin Clinic


Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Eczema

U.S. FDA Resources

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


Enrollment:	306
Study Start Date:	May 2011
Study Completion Date:	December 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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:

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


Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482663

Locations


Denmark
Dermatologic practise, Vesterbro 99
Aalborg, Denmark, 9000
Department of Dermato-Allergology, Copenhagen University Hospital Gentofte
Hellerup, Denmark, 2900

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

TrygFonden, Denmark

Investigators


Principal Investigator:	Annette Mollerup, MScHealth	Copenhagen University Hospital Gentofte
Study Director:	Jeanne D Johansen, Prof, DMSc	Copenhagen University Hospital Gentofte

More Information

Publications:

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Annette Mollerup, MScHealth, PhD-student, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:	NCT01482663 History of Changes
Other Study ID Numbers:	CHE-2011-Geh
Study First Received:	November 23, 2011
Last Updated:	December 2, 2014
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency

Keywords provided by University Hospital, Gentofte, Copenhagen:


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

Additional relevant MeSH terms:


Dermatitis Eczema Skin Diseases Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on March 03, 2015