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NCT Number: NCT01482663

Chronic Hand Eczema - Self-management and Prognosis

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.

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Key information

Conditions

Chronic Hand Eczema Chronic Hand Dermatitis Dermatitis Dermatitis, Contact Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatologic practise, Vesterbro 99, Aalborg, Denmark

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Skin Clinic

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.

Primary outcomes

  1. Hand Eczema Severity Index (HECSI)

    Time frame: 6 months

    Objective assessment of disease severity, measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.

Secondary outcomes

  1. Dermatology Life Quality Index (DLQI)

    Time frame: 6 months

    DLQI measured by questionnaire at time = 6 months versus DLQI measured by questionnaire at time = 0.

  2. Overall burden of disease (VAS)

    Time frame: 6 months

    VAS measured by questionnaire at time = 6 months versus VAS measured by questionnaire at time = 0.

  3. Danish version of The Medication Adherence Report Scale (DMARS-4)

    Time frame: 6 months

    DMARS-4 measured by questionnaire at time = 6 months versus DMARS-4 measured by questionnaire at time = 0 months.

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • TrygFonden, Denmark

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 30, 2011
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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