Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102356
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-21
Brief Title:
Impact of Clinical and Psychological Factors on Treatment Satisfaction in Psoriatic Patients in Biological Therapy
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Impact of Clinical and Psychological Factors on Treatment Satisfaction in Psoriatic Patients in Biological Therapy
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PsoSAT
Brief Summary:
This study aims to identify through the use of questionnaires demographic clinical and psychological factors that could better correlate with the satisfaction of psoriatic patients in systemic therapy with biological drugs for more than a year belonging to the Dermatology Clinics of the A Gemelli-IRCCS University Hospital
Detailed Description:
Psoriasis is a chronic inflammatory disease with a significant impact on the quality of life of those affected The introduction of monoclonal antibodies directed against key cytokines in the pathogenesis of the disease has so far allowed to obtain excellent results not only in terms of objective clinical response PASI90 PASI100 but also in terms of quality of life DLQI thanks to the speed of action the long-term response and the better safety profile compared to so-called traditional drugs such as cyclosporine methotrexate and acitretin
Patient satisfaction is one of the main elements to ensure the success of a systemic therapy for a chronic disease such as psoriasis as it is closely related to adherence to treatment Although the literature suggests that treatment satisfaction derives mainly from objective data such as the extent of residual disease there are no unequivocal data on which values of the disease severity index PASI are associated with greater patient satisfaction Recent studies have also shown that a certain percentage of patients who achieve optimal responses with biological therapies PASI90 PASI100 absolute PASI 2 still report an impact of the disease on their quality of life assessed by DLQI 2021 Life Basel Kirsten et al Which PASI OutcomeIs Most Relevant to the Patients in Real-World Care This paradox has been partly explained by the localization of residual disease in so-called sensitive sites and by the presence of a possible associated symptomatology but it is still partially unexplored how the psychological profile of the patient can influence this aspect DermatolTher 2022 Lebwol M et al Evolution of Patient Perceptions of Psoriatic Disease Results from the Understanding Psoriatic Disease Leveraging Insights for Treatment UPLIFT Survey In particular it remains to be clarified the weight of some psychopathological characteristics of patients and how these can negatively affect the quality of life and consequently satisfaction with treatment On the other hand it is known that there is an increased prevalence of numerous psychiatric pathologies in psoriatic patients depression bipolar disorder anxiety psychosis cognitive impairment sexual disorders sleep disorders eating behavior and personality disorders Rev Neurosci 2018 Amanat M et al Neurological and psychiatricdisorders in psoriasis
With regard to personality alterations several studies have shown an increased prevalence 374 of a particular personality profile Type D in patients with psoriasis this is a personality profile characterized by negative emotionality often associated with a higher incidence of psychiatric diseases such as anxiety and depression and which could affect satisfaction with therapies
Patient satisfaction is one of the main elements to ensure the success of a systemic therapy for a chronic disease such as psoriasis as it is closely related to adherence to treatment Although the literature suggests that treatment satisfaction derives mainly from objective data such as the extent of residual disease there are no unequivocal data on which values of the disease severity index PASI are associated with greater patient satisfaction Recent studies have also shown that a certain percentage of patients who achieve optimal responses with biological therapies PASI90 PASI100 absolute PASI 2 still report an impact of the disease on their quality of life assessed by DLQI 2021 Life Basel Kirsten et al Which PASI OutcomeIs Most Relevant to the Patients in Real-World Care This paradox has been partly explained by the localization of residual disease in so-called sensitive sites and by the presence of a possible associated symptomatology but it is still partially unexplored how the psychological profile of the patient can influence this aspect DermatolTher 2022 Lebwol M et al Evolution of Patient Perceptions of Psoriatic Disease Results from the Understanding Psoriatic Disease Leveraging Insights for Treatment UPLIFT Survey In particular it remains to be clarified the weight of some psychopathological characteristics of patients and how these can negatively affect the quality of life and consequently satisfaction with treatment On the other hand it is known that there is an increased prevalence of numerous psychiatric pathologies in psoriatic patients depression bipolar disorder anxiety psychosis cognitive impairment sexual disorders sleep disorders eating behavior and personality disorders Rev Neurosci 2018 Amanat M et al Neurological and psychiatricdisorders in psoriasis
With regard to personality alterations several studies have shown an increased prevalence 374 of a particular personality profile Type D in patients with psoriasis this is a personality profile characterized by negative emotionality often associated with a higher incidence of psychiatric diseases such as anxiety and depression and which could affect satisfaction with therapies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None