Clinical trial NCT02796014: Assessment of Dermatologic Family Impact Scale in the Parents of Children With Psoriasis
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Quality of Life
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
Collaborators: name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
name: Haseki Training and Research Hospital
name: Haydarpasa Numune Training and Research Hospital
name: Istanbul Training and Research Hospital
name: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
name: Sisli Hamidiye Etfal Training and Research Hospital
First posted: 2016-06-10
Enrollment: 129
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients clinically (andif necessary histopathologically) diagnosed with psoriasis \< 18 years of age

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.


Eligibility 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

Primary outcomes:
measure: Assessment of the impact of childhood psoriasis on the parents of the patients using the Dermatological Diseases Family Impact Scale
timeFrame: 6 months
Secondary outcomes:
measure: 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)
timeFrame: 6 months
measure: Delineating disease characteristics which influence the patients' and/or their parents' health-related quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Goztepe Research and Training Hospital
state: Kadikoy
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
city: Istanbul
country: Turkey
facility: Okmeydani Training and Research Hospital
city: Istanbul
country: Turkey
facility: Sisli Etfal Training & Research Hospital
Study officials:
affiliation: Istanbul Medeniyet University Goztepe Research and Training Hospital Department of Dermatology
name: Burak Tekin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
citation: Gurel MS, Yanik M, Simsek Z, Kati M, Karaman A. Quality of life instrument for Turkish people with skin diseases. Int J Dermatol. 2005 Nov;44(11):933-8. doi: 10.1111/j.1365-4632.2004.02225.x.
citation: Lewis-Jones MS, Finlay AY. The Children's Dermatology Life Quality Index (CDLQI): initial validation and practical use. Br J Dermatol. 1995 Jun;132(6):942-9. doi: 10.1111/j.1365-2133.1995.tb16953.x.
citation: Basra MK, Sue-Ho R, Finlay AY. The Family Dermatology Life Quality Index: measuring the secondary impact of skin disease. Br J Dermatol. 2007 Mar;156(3):528-38. doi: 10.1111/j.1365-2133.2006.07617.x.
citation: Eghlileb AM, Basra MK, Finlay AY. The psoriasis family index: preliminary results of validation of a quality of life instrument for family members of patients with psoriasis. Dermatology. 2009;219(1):63-70. doi: 10.1159/000209234. Epub 2009 Mar 13.
citation: Tadros A, Vergou T, Stratigos AJ, Tzavara C, Hletsos M, Katsambas A, Antoniou C. Psoriasis: is it the tip of the iceberg for the quality of life of patients and their families? J Eur Acad Dermatol Venereol. 2011 Nov;25(11):1282-7. doi: 10.1111/j.1468-3083.2010.03965.x. Epub 2011 Jan 17.
citation: Ganemo A, Wahlgren CF, Svensson A. Quality of life and clinical features in Swedish children with psoriasis. Pediatr Dermatol. 2011 Jul-Aug;28(4):375-9. doi: 10.1111/j.1525-1470.2010.01292.x. Epub 2011 Jul 8.