- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07793773
Disease Impact and Its Correlation With Disease Activity in Psoriatic Arthritis
Assessment of Disease Impact in Patients With Psoriatic Arthritis and Its Correlation With Disease Activity
Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disorder that causes joint pain, stiffness, skin lesions, and functional disability, significantly affecting patients' quality of life. Patient-reported outcome measures (PROMs) provide essential insights into the impact of disease from the patient's perspective. The Psoriatic Arthritis Impact of Disease-12 (PsAID-12) questionnaire is a validated tool designed to evaluate 12 physical and psychological aspects of disease burden.
The main purpose of this cross-sectional study is to evaluate disease impact using the Arabic version of the PsAID-12 questionnaire and to investigate how disease impact correlates with clinical disease activity measured by the Disease Activity in Psoriatic Arthritis (DAPSA) score in adult patients with PsA.
Participants will undergo routine clinical and rheumatological evaluations, including joint examinations (tender and swollen joint counts), laboratory tests (complete blood count, inflammatory markers such as ESR and CRP, liver and kidney function tests, and lipid profile), and plain radiography of affected joints (hands, feet, and sacroiliac joints). Patients will also complete the Arabic PsAID-12 questionnaire and patient global and pain assessments. All assessments will take place during a single evaluation visit at Assiut University Hospital.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients diagnosed with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria
- Age ≥ 18 years
- Willingness to participate in the study and provide informed consent
Exclusion Criteria:
- Patients younger than 18 years of age
- Presence of other coexisting autoimmune diseases
- Patients with advanced malignancy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Psoriatic Arthritis Patients
Adult patients aged 18 years or older diagnosed with psoriatic arthritis fulfilling the CASPAR (Classification Criteria for Psoriatic Arthritis) criteria who are attending the inpatient or outpatient clinics of the Rheumatology, Rehabilitation and Physical Medicine Department at Assiut University Hospital.
Patients undergo evaluation for disease impact using the Arabic 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaire and assessment of disease activity via the Disease Activity in Psoriatic Arthritis (DAPSA) score.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Disease Impact Score Assessed by the Psoriatic Arthritis Impact of Disease (PsAID-12) Questionnaire
Délai: Baseline
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The Arabic version of the Psoriatic Arthritis Impact of Disease 12-item (PsAID-12) questionnaire is used to evaluate patient-reported disease impact.
It assesses 12 domains: pain, fatigue, skin problems, work and leisure activities, functional capacity, discomfort, sleep disturbance, coping, anxiety/fear, embarrassment/shame, social participation, and depression.
Each domain is scored on a numerical rating scale from 0 to 10, weighted, and aggregated into a total score ranging from 0 (no impact/best status) to 10 (extreme impact/worst status).
Higher total scores indicate greater negative disease impact.
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Baseline
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Psoriatic Arthritis Impact
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