Assessment of Dermatologic Family Impact Scale in the Parents of Children With Psoriasis

August 16, 2017 updated by: burak tekin, Istanbul Medeniyet University

Assessment of Dermatologic Family Impact Scale in the Parents of Children With Psoriasis, and Comparison of This Scale With the Children's Dermatology Life Quality Index and Disease Severity

The Dermatological Diseases Family Impact Scale (DeFIS) was developed to assess different aspects of health-related quality of life in the relatives of the patients with various skin diseases. The preliminary validation of this instrument was performed for the Turkish population. In the pilot study, this 15-item-questionnaire was shown to be easy to complete and score, and reliably help to evaluate the family members' quality of life.

Psoriasis is a chronic disease which can be expected to have a significant impact on the quality of life of the patients and parents/family members alike. In line with this assumption, previous studies demonstrated that psoriasis psychosocially affects not only the patients, but also their close relatives. The psoriasis family index has been developed in an effort to objectively measure the health-related quality of life of the family members of patients with psoriasis. Nevertheless, data regarding the health-related quality of life of the parents of pediatric patients with psoriasis in the Turkish population are relatively scarce.

In study, the investigators primarily aim to utilize DeFIS to assess the impact of childhood psoriasis on the quality of life of the patients' parents. Further, the investigators attempt to investigate the relation between the quality of life of the patients and their parents, and reveal disease characteristics which might influence the quality of life.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

129

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

  • Turkey
      • Istanbul, Turkey
        • Haseki Training and Research Hospital
      • Istanbul, Turkey
        • Istanbul Training and Research Hospital
      • Istanbul, Turkey
        • Bakirkoy Dr. Sadi Konuk Research and Training Hospital
      • Istanbul, Turkey
        • Haydarpasa Numune Training and Research Hospital
      • Istanbul, Turkey
        • Okmeydani Training and Research Hospital
      • Istanbul, Turkey
        • Sisli Etfal Training & Research Hospital
    • Kadikoy
      • Istanbul, Kadikoy, Turkey, 34720
        • Istanbul Medeniyet University Goztepe Research and TRaining Hospital

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

3 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients clinically (andif necessary histopathologically) diagnosed with psoriasis < 18 years of age

Description

Inclusion Criteria:

  • Pediatric patients diagnosed with psoriasis by the dermatologists within the study period

Exclusion Criteria:

  • Patients with an equivocal diagnosis
  • Parents unable to complete the questionnaire
  • Patients with a serious medical disorder or in an emergency condition

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the impact of childhood psoriasis on the parents of the patients using the Dermatological Diseases Family Impact Scale
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the quality of life of the parents (as evaluated using the Dermatological Diseases Family Impact Scale) with the quality of life of the patients (as assessed using the Children's Dermatology Life Quality Index)
Time Frame: 6 months
6 months
Delineating disease characteristics which influence the patients' and/or their parents' health-related quality of life
Time Frame: 6 months
Disease characteristics such as age of onset, disease subtype, psoriasis area and severity index and scalp involvement will be recorded. The impact of these parameters on quality of life will be assessed using statistical methods.
6 months

Collaborators and Investigators

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

Sponsor

Istanbul Medeniyet University

Collaborators

Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul Training and Research Hospital
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sisli Hamidiye Etfal Training and Research Hospital
Haseki Training and Research Hospital
Haydarpasa Numune Training and Research Hospital

Investigators

  • Principal Investigator: Burak Tekin, M.D., Istanbul Medeniyet University Goztepe Research and Training Hospital Department of Dermatology

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

Helpful Links

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

May 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/0118

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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