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

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ClinicalTrials.gov Identifier: NCT02796014
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : August 21, 2017
Sponsor:
Collaborators:
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Haseki Training and Research Hospital
Haydarpasa Numune Training and Research Hospital
Istanbul Training and Research Hospital
Okmeydani Training and Research Hospital
Sisli Hamidiye Etfal Training and Research Hospital
Information provided by (Responsible Party):
burak tekin, Istanbul Medeniyet University

Brief Summary:

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.


Condition or disease
Psoriasis Quality of Life

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Study Type : Observational
Actual Enrollment : 129 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Study Start Date : May 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis




Primary Outcome Measures :
  1. Assessment of the impact of childhood psoriasis on the parents of the patients using the Dermatological Diseases Family Impact Scale [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients clinically (andif necessary histopathologically) diagnosed with psoriasis < 18 years of age
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796014


Locations
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Turkey
Istanbul Medeniyet University Goztepe Research and Training Hospital
Istanbul, Kadikoy, Turkey, 34720
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul, Turkey
Haseki Training and Research Hospital
Istanbul, Turkey
Haydarpasa Numune Training and Research Hospital
Istanbul, Turkey
Istanbul Training and Research Hospital
Istanbul, Turkey
Okmeydani Training and Research Hospital
Istanbul, Turkey
Sisli Etfal Training & Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Istanbul Medeniyet University
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Haseki Training and Research Hospital
Haydarpasa Numune Training and Research Hospital
Istanbul Training and Research Hospital
Okmeydani Training and Research Hospital
Sisli Hamidiye Etfal Training and Research Hospital
Investigators
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Principal Investigator: Burak Tekin, M.D. Istanbul Medeniyet University Goztepe Research and Training Hospital Department of Dermatology

Additional Information:
Publications:
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Responsible Party: burak tekin, Dr, M.D., Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT02796014     History of Changes
Other Study ID Numbers: 2016/0118
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases