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Psoriasis is a chronic-recurrent inflammatory disease with a significant impact on patients' physical and psychological well-being. Fortunately, in recent years, the introduction of increasingly selective biologic therapies on the market has resulted in an excellent control of the disease, with high rates of complete (PASI100) or nearly complete (PASI90) in treated patients. At the same time, however, various studies have shown that these patients' quality of life and satisfaction with these therapies do not always correlate with the high levels of efficacy of these drugs, and this is often a limitation, as it has negative feedbacks on treatment adherence. This study aims to identify, through the use of questionnaires, demographic, clinical and psychological factors that might best correlate with the satisfaction of psoriatic patients on therapy systemic with biologic drugs for more than one year afferent to the Dermatology Outpatient Clinics of the Policlinico Universitario A. Gemelli-IRCCS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients diagnosed with psoriasis | Psoriasis already treated with a systemic biologic drug for at least one year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | DLQI, PHQ 9, TSQM 2, DS14 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome assessed by Treatment Satisfaction Questionnaire for Medication (TSQM-9) - towards treatment, in a sample of psoriatic patients on therapy for more than one year with a biologic drug | The primary objective of the study is to evaluate satisfaction with treatment of psoriatic patients who have been on therapy for at least one year with a biologic drug. Satisfaction will be expressed in terms of a score derived from the Treatment Satisfaction Questionnaire for Medication (TSQM-9).(0-100) higher scores mean a better outcome. | 1 year |
| DLQI | Evaluate after 1 year of treatment with biologic drug:
| 1 year |
| Effect of clinical variables on satisfaction of treatment | Evaluate the effect of objectively measurable clinical variables such as:
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Type D personality with satisfaction with treatment. | As a secondary objective, the relationship of specific characteristics will also be assessed. psychopathology (Type D personality, Depression) with satisfaction with treatment. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with Psoriasis referred to the outpatient clinics of Dermatology and Venereology of FPG already treated with a systemic biologic drug for at least one year.
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| Name | Affiliation | Role |
|---|---|---|
| Giacomo Caldarola | Università Cattolica del Sacro Cuore, Roma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli | Rome | Lazio | 00168 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2023 | Sep 22, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |