NCT02796014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

June 7, 2016

Last Update Submit

August 16, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of the impact of childhood psoriasis on the parents of the patients using the Dermatological Diseases Family Impact Scale

    6 months

Secondary Outcomes (2)

  • 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)

    6 months

  • Delineating disease characteristics which influence the patients' and/or their parents' health-related quality of life

    6 months

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Istanbul Medeniyet University Goztepe Research and Training Hospital

Istanbul, Kadikoy, 34720, Turkey (Türkiye)

Location

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Haydarpasa Numune Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Okmeydani Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Sisli Etfal Training & Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 8033378BACKGROUND
  • 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.

    PMID: 16336527BACKGROUND
  • 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.

    PMID: 7662573BACKGROUND
  • 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.

    PMID: 17300244BACKGROUND
  • 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.

    PMID: 19295185BACKGROUND
  • 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.

    PMID: 21241373BACKGROUND
  • 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.

    PMID: 21736605BACKGROUND

Related Links

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Burak Tekin, M.D.

    Istanbul Medeniyet University Goztepe Research and Training Hospital Department of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, M.D.

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 10, 2016

Study Start

May 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations