Intervention Study to Evaluate the Importance of Information Given to Patients With Contact Allergy (ISICA-13)

April 11, 2017 updated by: Andreas Sonesson, Region Skane
The purpose of this study is to determine whether extended information given to patients with contact allergy improves knowledge, treatment efficacy and daily functioning.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne
      • Lund, Skåne, Sweden, 22185
        • Hudmottagningen SUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with suspected contact allergy
  • Age above 18 years
  • Participants have given informed consent

Exclusion Criteria:

  • Mental or language disabilities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: extended information
Extended information on specific allergy
Behavioral: extended information
No Intervention: Information according to clin. routine
Information according to clinical routine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
knowledge
Time Frame: one year after inclusion
knowledge about specific contact allergies and exposure, assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and patient records.
one year after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical improvement
Time Frame: one year after inclusion
assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and patient records.
one year after inclusion
quality of life
Time Frame: one year after inclusion
assessed by questionnaire, Dermatology Life Quality Index (DLQI).
one year after inclusion
effect on daily functioning
Time Frame: one year after inclusion
assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and Dermatology Life Quality Index (DLQI).
one year after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Principal Investigator: Andreas Sonesson, MD PhD, Region Skåne, Hudkliniken SUS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISICA-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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