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Chronic Hand Eczema - Self-management and Prognosis

NCT ID: NCT01482663

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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

Conditions

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Chronic Hand Eczema Chronic Hand Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Chronic hand eczema patients

Written information sheets and a 14-minutes DVD about hand eczema handed out by the dermatologist

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Healthy Skin Clinic

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TrygFonden, Denmark

INDUSTRY

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Annette Mollerup

MScHealth, PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Annette Mollerup, MScHealth

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Gentofte, Copenhagen

Jeanne D Johansen, Prof, DMSc

Role: STUDY_DIRECTOR

University Hospital, Gentofte, Copenhagen

Locations

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Dermatologic practise, Vesterbro 99

Aalborg, , Denmark

Site Status

Department of Dermato-Allergology, Copenhagen University Hospital Gentofte

Hellerup, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 24766387 (View on PubMed)

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.

Reference Type RESULT
PMID: 24618009 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22691871 (View on PubMed)

Other Identifiers

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CHE-2011-Geh

Identifier Type: -

Identifier Source: org_study_id