Evaluation of the Sensitivity and Specificity of a Novel Quality of Life Tool to Assess the Treatment Satisfaction in Psoriasis Patients

Psoriasis Clinical Trial

— PSO-TARGET  

Official title:

Evaluation of the Sensitivity and Specificity of a Novel Quality of Life (QoL) Tool to Assess the Treatment Satisfaction in Psoriasis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04765332
• Other study ID #: PSO-TARGET
• Status: Completed
• Start date: December 4, 2020
• Est. completion date: March 13, 2023

Study information

• Verified date: August 2023
• Source: Clinact
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The severity of psoriasis can be influenced by a great variety of factors including extent of the disease, lesions location and impact on quality of life. The current standard of care for psoriasis is focusing on the reduction of the skin symptoms as defined by the PASI, somewhat setting asides the patient's feelings in terms of which aspects of his/her life are affected by the disease. Despite the fact that multiple patient reported outcomes (PRO) questionnaires are available to evaluate the impact of the disease on patients' quality of life, only few items address the subjective impact of skin disease. Among the available PROs the Dermatology Life Quality Index (DLQI) is the most frequently used. It is a standardized tool designed to cover a broad range of dermatologic afflictions but lacks specificity towards the effect of psoriasis on quality of life. The DLQI is composed of ten questions grouped in 6 domains "symptoms and feelings", "daily activities", "leisure", "work/school", "personal relationships" and "treatment". Each answer is graded from 0 to 3. The DLQI score is calculated by adding the score of each question, resulting in a maximum score of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.

Because of its limitations, some patients cannot seem to completely restore a normal quality of life (e.g. DLQI 0-1) even though their reached a perfect PASI score (100). This phenomenon may be explained by the fact that the patient's own perception can be different from the physician's perspective and may have changed in time, between follow-ups. These are as many reasons as why it is highly difficult to accurately fathom the therapeutic expectations of the psoriasis patients. The standard tools currently in use are not able to assess the perception of the disease by the patient its evolution over time. In addition, it is widely recognized that alexithymia is more prevalent in the psoriasis patients than in the general population and patients with alexithymia appear to suffer higher psoriasis burden as they have more difficulties to express their expectations. Since patients struggle to recognize and verbalize their emotions, it can be useful and informative to offer patients a variety of verbatim in which they can identify. PSO-TARGET is an exploratory observational, non-interventional study aiming to evaluate a novel approach of assessing psoriasis patients' satisfaction towards their biologic treatment from a quality of life standpoint by using a psoriasis-specific Quality of Life assessment grid.

The aim of this exploratory study is to evaluate the sensitivity and specificity of the PSO-TARGET QoL Component grid as part of a new approach for assessing the level of achievement of the psoriasis patient's therapeutic goal, identified by himself, after a treatment with Kyntheum®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: March 13, 2023
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Patient for whom the dermatologist decided to initiate a treatment by Kyntheum® according to SmPC.

• Patient who signed an informed consent

Exclusion Criteria:

• Vulnerable subjects according to the law;

• pregnant, parturient or breast feeding women;

• deprived of their freedom by administrative, medical or legal decision or who is under trusteeship/guardianship;

• legally protected, or unable to express their consent to participate;

• With no affiliation to a social security system;

• Psychologically/linguistically unable to express their consent to participate

• With an hypersensitivity to at least one of the excipients of Kyntheum®

• Participating at the same time in another clinical trial

Related Conditions & MeSH terms

• Psoriasis

Intervention

Other:
• DLQI and PSO-TARGET QoL grid
At inclusion visit, and after 3 and 12 months, the patient will fill a patient questionnaire containing DLQI and PSO-TARGET QoL grid

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc - UCLouvain	Bruxelles
Belgium	Private practice	Geel
Belgium	Private practice	Genk
Belgium	Private practice	Kalken
Belgium	Centre Dermatologique du Roy	Lasne
Belgium	Dermatology Maldegem	Maldegem
Belgium	CHU Ambroise Paré	Mons
Belgium	CHU UCL Namur - Sainte Elisabeth	Namur
Belgium	Private practice	Namur
Belgium	Private practice	Waregem
France	Chu de Rennes	Auray
France	Chru de Besancon - Hopital Jean Minjoz	Besançon
France	Polyclinique de Courlancy-Bezanes	Bezannes
France	Centre Hospitalier de Boulogne-sur-mer	Boulogne-sur-Mer
France	CHU de CAEN	Caen
France	Ch William Morey	Chalon-sur-Saône
France	Nouvel Hôpital Sud Francilien	Corbeil-Essonnes
France	Ch Annecy Genevois	Épagny
France	Hopital Jacques Monod	Montivilliers
France	Cide Azur	Nice
France	Ch Cote de Lumiere	Olonne-sur-Mer
France	Hopital Paris Saint-Joseph	Paris
France	Ch de Perpignan	Perpignan
France	CHU de Poitiers	Poitiers
France	Hôpital d'Instruction des armées SAINTE ANNE	Toulon
France	Hopital Larrey	Toulouse
France	CHRU de NANCY - BSM BRABOIS	Vandœuvre-lès-Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Clinact	LEO Pharma

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of concordance between the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid and the DLQI in assessing the impact of the treatment on the patients' quality of life.		At first follow-up visit (around 12 weeks)
Secondary	The percentage of patients who achieved the main treatment goal identified by the patient himself in the QoL component grid at baseline.	The therapeutic objective achievement is defined as "satisfied" or "very satisfied" response on 4 points Likert scale.	At first follow-up visit (around 12 weeks)
Secondary	Level of concordance between the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid and the DLQI		At last follow up (around 52 weeks)
Secondary	Research of predictive factors (among baseline characteristics) of the achievement of the main treatment goal.		At first follow-up visit (around 12 weeks)
Secondary	Percentage of agreement between the physician-reported and the patient-reported dimensions		At first follow-up visit (around 12 weeks)
Secondary	Rate of patients having changed objective at the 1st follow-up visit		At first follow-up visit (around 12 weeks)
Secondary	Percentage of patients who have maintained at 52 ± 4 weeks the level of satisfaction achieved at the 1st follow-up visit.		At last follow up (around 52 weeks)
Secondary	Psoriasis Area and Severity Index (PASI)	Calculation of the percentage of skin surface area affected. Estimation of how many hands surface (palm + fingers) of the patient correspond to psoriatic lesions. one hand surface is considered as 1% of total body skin surface	at baseline
Secondary	Psoriasis Area and Severity Index (PASI)	Calculation of the percentage of skin surface area affected. Estimation of how many hands surface (palm + fingers) of the patient correspond to psoriatic lesions. one hand surface is considered as 1% of total body skin surface	at the 1st follow-up visit ), at the 2nd follow-up visit (52 ± 4 weeks.).
Secondary	Psoriasis Area and Severity Index (PASI)	Calculation of the percentage of skin surface area affected. Estimation of how many hands surface (palm + fingers) of the patient correspond to psoriatic lesions. one hand surface is considered as 1% of total body skin surface	at the 2nd follow-up visit (around 52 weeks.).
Secondary	Level of accordance between PASI 90/100 and the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid.		at baseline, at the 1st follow-up visit (12/ 16 weeks), at the 2nd follow-up visit 52 ± 4 weeks.
Secondary	Level of accordance between PASI 90/100 and the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid.		at the 1st follow-up visit (around 12 weeks)
Secondary	Level of accordance between PASI 90/100 and the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid.		at the 2nd follow-up visit (around 52 weeks)
Secondary	Dermatology Life Quality Index (DLQI Scores)	Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)	at baseline
Secondary	Dermatology Life Quality Index (DLQI Scores)	Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)	at the 1st follow-up visit (around 12 weeks)
Secondary	Dermatology Life Quality Index (DLQI Scores)	Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)	at the 2nd follow-up visit (around 52 weeks)