Assessment of Dermatologic Family Impact Scale in the Par... | NCT02796014

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

NCT02796014

Sponsor

Istanbul Medeniyet University

Status

Completed

Last Update Posted

Aug 21, 2017Actual

Enrollment

129Actual

Phase

Not provided

Conditions

Psoriasis
Quality of Life

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Mar 2017Actual

Completion Date

Mar 2017Actual

First Submitted Date

Jun 7, 2016

First Submission Date that Met QC Criteria

Jun 9, 2016

First Posted Date

Jun 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2017

Last Update Posted Date

Aug 21, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

burak tekin, Dr, M.D., Istanbul Medeniyet UniversityPrincipal Investigator

Lead Sponsor

Istanbul Medeniyet UniversityOTHER

Collaborators

Name	Class
Bakirkoy Dr. Sadi Konuk Research and Training Hospital	OTHER_GOV
Haseki Training and Research Hospital	OTHER
Haydarpasa Numune Training and Research Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

129Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Burak Tekin, M.D.	Istanbul Medeniyet University Goztepe Research and Training Hospital Department of Dermatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Medeniyet University Goztepe Research and Training Hospital		Istanbul	Kadikoy	34720	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8033378	Background	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.
16336527	Background	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.

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases