Quality of Life Clinical Trial
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
| Verified date | August 2017 |
| Source | Istanbul Medeniyet University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 129 |
| Est. completion date | March 2017 |
| Est. primary completion date | March 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Months to 18 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | 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 Medeniyet University Goztepe Research and Training Hospital | Istanbul | Kadikoy |
| Turkey | Istanbul Training and Research Hospital | Istanbul | |
| Turkey | Okmeydani Training and Research Hospital | Istanbul | |
| Turkey | Sisli Etfal Training & Research Hospital | Istanbul |
| Lead Sponsor | Collaborator |
|---|---|
| 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 Etfal Training & Research Hospital |
Turkey,
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. Erratum in: Br J Dermatol. 2007 Apr;156(4):791. — View 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. — View 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. — View Citation
Gånemo A, Wahlgren CF, Svensson Å. 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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessment of the impact of childhood psoriasis on the parents of the patients using the Dermatological Diseases Family Impact Scale | 6 months | ||
| Secondary | 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 | ||
| Secondary | 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. | 6 months |
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