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Chronic Hand Eczema - Self-management and Prognosis

Primary Purpose

Chronic Hand Eczema, Chronic Hand Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Healthy Skin Clinic
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Hand Eczema focused on measuring Hand eczema, Hand dermatitis, Chronic hand eczema, Chronic hand dermatitis, Contact dermatitis, Skin disease, Self-management

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dermatologic practise, Vesterbro 99
  • Department of Dermato-Allergology, Copenhagen University Hospital Gentofte

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Chronic hand eczema patients

Behavioral: Healthy Skin Clinic

Arm Description

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

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

Outcomes

Primary Outcome Measures

Hand Eczema Severity Index (HECSI)
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)
DLQI measured by questionnaire at time = 6 months versus DLQI measured by questionnaire at time = 0.
Overall burden of disease (VAS)
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)
DMARS-4 measured by questionnaire at time = 6 months versus DMARS-4 measured by questionnaire at time = 0 months.

Full Information

First Posted
November 23, 2011
Last Updated
December 2, 2014
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
TrygFonden, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01482663
Brief Title
Chronic Hand Eczema - Self-management and Prognosis
Official Title
Chronic Hand Eczema - Self-management and Prognosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
TrygFonden, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hand Eczema, Chronic Hand Dermatitis
Keywords
Hand eczema, Hand dermatitis, Chronic hand eczema, Chronic hand dermatitis, Contact dermatitis, Skin disease, Self-management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic hand eczema patients
Arm Type
No Intervention
Arm Description
Written information sheets and a 14-minutes DVD about hand eczema handed out by the dermatologist
Arm Title
Behavioral: Healthy Skin Clinic
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Healthy Skin Clinic
Intervention Description
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 Outcome Measure Information:
Title
Hand Eczema Severity Index (HECSI)
Description
Objective assessment of disease severity, measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Dermatology Life Quality Index (DLQI)
Description
DLQI measured by questionnaire at time = 6 months versus DLQI measured by questionnaire at time = 0.
Time Frame
6 months
Title
Overall burden of disease (VAS)
Description
VAS measured by questionnaire at time = 6 months versus VAS measured by questionnaire at time = 0.
Time Frame
6 months
Title
Danish version of The Medication Adherence Report Scale (DMARS-4)
Description
DMARS-4 measured by questionnaire at time = 6 months versus DMARS-4 measured by questionnaire at time = 0 months.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette Mollerup, MScHealth
Organizational Affiliation
Copenhagen University Hospital, Gentofte
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeanne D Johansen, Prof, DMSc
Organizational Affiliation
Copenhagen University Hospital, Gentofte
Official's Role
Study Director
Facility Information:
Facility Name
Dermatologic practise, Vesterbro 99
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Department of Dermato-Allergology, Copenhagen University Hospital Gentofte
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24766387
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.
Results Reference
result
PubMed Identifier
24618009
Citation
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.
Results Reference
result
PubMed Identifier
22691871
Citation
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.
Results Reference
derived

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Chronic Hand Eczema - Self-management and Prognosis

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