Back to resultsIntervention Study to Evaluate the Importance of Information Given to Patients With Contact Allergy (ISICA-13)
Primary Purpose
Dermatitis, Allergic Contact
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
extended information
Sponsored by
About this trial
This is an interventional prevention trial for Dermatitis, Allergic Contact focused on measuring Intervention Studies, Eczema, Randomized Controlled Trial, Knowledge, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- Patients with suspected contact allergy
- Age above 18 years
- Participants have given informed consent
Exclusion Criteria:
- Mental or language disabilities
Sites / Locations
- Hudmottagningen SUS
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
extended information
Information according to clin. routine
Arm Description
Extended information on specific allergy
Information according to clinical routine
Outcomes
Primary Outcome Measures
knowledge
knowledge about specific contact allergies and exposure, assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and patient records.
Secondary Outcome Measures
clinical improvement
assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and patient records.
quality of life
assessed by questionnaire, Dermatology Life Quality Index (DLQI).
effect on daily functioning
assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and Dermatology Life Quality Index (DLQI).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01953380
Brief Title
Intervention Study to Evaluate the Importance of Information Given to Patients With Contact Allergy
Acronym
ISICA-13
Official Title
Intervention Study to Evaluate the Importance of Information Given to Patients With Contact Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether extended information given to patients with contact allergy improves knowledge, treatment efficacy and daily functioning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Allergic Contact
Keywords
Intervention Studies, Eczema, Randomized Controlled Trial, Knowledge, Quality of Life
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
extended information
Arm Type
Active Comparator
Arm Description
Extended information on specific allergy
Arm Title
Information according to clin. routine
Arm Type
No Intervention
Arm Description
Information according to clinical routine
Intervention Type
Behavioral
Intervention Name(s)
extended information
Primary Outcome Measure Information:
Title
knowledge
Description
knowledge about specific contact allergies and exposure, assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and patient records.
Time Frame
one year after inclusion
Secondary Outcome Measure Information:
Title
clinical improvement
Description
assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and patient records.
Time Frame
one year after inclusion
Title
quality of life
Description
assessed by questionnaire, Dermatology Life Quality Index (DLQI).
Time Frame
one year after inclusion
Title
effect on daily functioning
Description
assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and Dermatology Life Quality Index (DLQI).
Time Frame
one year after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with suspected contact allergy
Age above 18 years
Participants have given informed consent
Exclusion Criteria:
Mental or language disabilities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Sonesson, MD PhD
Organizational Affiliation
Region Skåne, Hudkliniken SUS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hudmottagningen SUS
City
Lund
State/Province
Skåne
ZIP/Postal Code
22185
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
35794786
Citation
Mossing K, Dizdarevic A, Svensson A, Sonesson A. Impact on quality of life of an intervention providing additional information to patients with allergic contact dermatitis; a randomized clinical trial. J Eur Acad Dermatol Venereol. 2022 Nov;36(11):2166-2171. doi: 10.1111/jdv.18412. Epub 2022 Jul 18.
Results Reference
derived
Learn more about this trial
Intervention Study to Evaluate the Importance of Information Given to Patients With Contact Allergy
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