PsoriasisNCT02796014
Assessment of Dermatologic Family Impact Scale in the Parents of Children With Psoriasis
An observational study of Psoriasis and Quality of Life, run by Istanbul Medeniyet University at 7 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Psoriasis, Quality of Life
- How many people
- 129 participants
- Where
- 7 sitesTurkey (Türkiye)
- Study dates
- May 2016to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients clinically (andif necessary histopathologically) diagnosed with psoriasis < 18 years of age
Who may be able to join
- Pediatric patients diagnosed with psoriasis by the dermatologists within the study period
Who cannot join
- Patients with an equivocal diagnosis
- Parents unable to complete the questionnaire
- Patients with a serious medical disorder or in an emergency condition
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Turkey (Türkiye)7 sites
Istanbul Medeniyet University Goztepe Research and Training Hospital
Istanbul, Kadikoy, 34720
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul
Haseki Training and Research Hospital
Istanbul
Haydarpasa Numune Training and Research Hospital
Istanbul
Istanbul Training and Research Hospital
Istanbul
Okmeydani Training and Research Hospital
Istanbul
Sisli Etfal Training & Research Hospital
Istanbul
About this study
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
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.
- Conditions
- Psoriasis, Quality of Life
- Medical subject headings
- Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the impact of childhood psoriasis on the parents of the patients using the Dermatological Diseases Family Impact Scale
Measured: 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)
Measured: 6 months
Delineating disease characteristics which influence the patients' and/or their parents' health-related quality of life
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- 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, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization, Sisli Hamidiye Etfal Training and Research Hospital
- Responsible party
- Principal investigator, burak tekin, Istanbul Medeniyet University
- Investigators
- Burak Tekin, M.D., Principal investigator, Istanbul Medeniyet University Goztepe Research and Training Hospital Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796014
- Sponsor's protocol ID
- 2016/0118
- Status last verified
- Aug 2017
- First submitted
- 7 Jun 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8033378Gurel 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.
PubMed 16336527Lewis-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.
PubMed 7662573Basra 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.
PubMed 17300244Eghlileb 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.
PubMed 19295185Tadros 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.
PubMed 21241373Ganemo 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.
PubMed 21736605
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02796014
- Acronym / sponsor ID
- 2016/0118
- Conditions
- Psoriasis, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- 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, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization, Sisli Hamidiye Etfal Training and Research Hospital
- Study start
- May 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients clinically (andif necessary histopathologically) diagnosed with psoriasis < 18 years of age
Key inclusion criteria (1 listed)
- Pediatric patients diagnosed with psoriasis by the dermatologists within the study period
Key exclusion criteria (3 listed)
- Patients with an equivocal diagnosis
- Parents unable to complete the questionnaire
- Patients with a serious medical disorder or in an emergency condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the impact of childhood psoriasis on the parents of the patients using the Dermatological Diseases Family Impact Scale
Time frame: 6 months
2 secondary outcomes
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
Delineating disease characteristics which influence the patients' and/or their parents' health-related quality of life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Background: PubMed 8033378Finlay 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.
- Background: PubMed 16336527Gurel 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.
- Background: PubMed 7662573Lewis-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.
- Background: PubMed 17300244Basra 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.
- Background: PubMed 19295185Eghlileb 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.
- Background: PubMed 21241373Tadros 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.
- Background: PubMed 21736605Ganemo 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.
- Development and preliminary validation of the dermatological family impact scaleLink provided by the sponsor.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burak Tekin, M.D. principal investigator
Istanbul Medeniyet University Goztepe Research and Training Hospital Department of Dermatology
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Quality of Life, run by Istanbul Medeniyet University at 7 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the impact of childhood psoriasis on the parents of the patients using the Dermatological Diseases Family Impact Scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02796014, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.