- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Disease Impact Score Assessed by the Psoriatic Arthritis Impact of Disease (PsAID-12) Questionnaire
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Psoriatic Arthritis Impact
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