- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07682363
Management Concepts of Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) Among Chinese Physicians
Attitudes, Perceptions, Clinical Practice, and Barriers in Diagnosis and Management of Patients With Metabolic Dysfunction-associated Steatotic Liver Disease: a Cross-sectional Survey on Physicians in China
Studieoversikt
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-post: clinicaltrials@novonordisk.com
Studiesteder
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Beijing, Kina
- Rekruttering
- Novo Nordisk Investigational Site
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Has provided informed consent.
- Registered clinical practice location in provincial capital or municipality.
- Physician with a license for clinical practice.
- Employed in the Department of Endocrinology, Hepatology, Infection or Gastroenterology.
- Hospital level: Grade IIIA hospital.
- Hold a professional title of associate chief physician or above, or senior attending physician (as an attending physician for more than or equal to (≥) 3 years).
- Conducts outpatient clinics for at least 1 half-days per week.
- The patient load of MASLD/MASH per month in the department should be:
- a. Endocrinology ≥20 patients per month
- b. Hepatology/Gastroenterology/ Infectious ≥30 patients per month
Exclusion Criteria:
-Participants will be excluded if they have unwillingness precluding adequate cooperation, fail to complete the questionnaire, or submit questionnaires verified as invalid.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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Physicians treating MASLD
The survey will be conducted via 15-minute online questionnaire survey of 30 specialists in the departments of endocrinology, hepatology, infection, and gastroenterology.
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This study is a cross-sectional survey-based study.
The design is observational and descriptive.
Collection of data will be performed via a quantitative online survey.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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To investigate attitudes and perceptions concerning the reasons for further severity assessment (mainly refers to the assessment of liver fibrosis) following a MASLD diagnosis
Tidsramme: At the data capture (Day 1)
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The reason for severity assessment will be measured via questionnaires. The corresponding questionnaire items were designed to explore whether physicians would conduct further evaluation for patients diagnosed with MASLD and what dimensions such further evaluation would cover. Details of the questions are shown below:
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At the data capture (Day 1)
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Methods used for diagnose liver fibrosis
Tidsramme: At the data capture (Day 1)
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Methods used for liver fibrosis diagnosis will be assessed via questionnaires. The corresponding questionnaire items asked physicians to select the examinations they use to assess the stage of liver fibrosis in patients with MASLD. For physicians who perform liver fibrosis staging: Among patients with confirmed MASLD, which of the following tools do you use in routine clinical practice to evaluate liver fibrosis stage? Available response options include FibroScan, FibroTouch, Magnetic Resonance Elastography (MRE), fibrosis-specific serological tests (e.g., PIIINP, C-IV, LN, HA), simple scoring systems (e.g., FIB-4, NFS, APRI), and others (please specify). |
At the data capture (Day 1)
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To find percentages of patients who undergo different liver fibrosis examination
Tidsramme: At the data capture (Day 1)
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Percentages of patients who undergo different liver fibrosis examination will be measured via questionnaires. The corresponding questionnaire items asked physicians to report the proportion of patients with MASLD for whom they utilize each liver fibrosis assessment method in routine clinical practice. For each selected examination tool, physicians report the proportion of patients receiving the test in their daily clinical work using predefined categories (≤10%, 10%-25%, 25%-50%, 50%-75%, and 75%-100%). |
At the data capture (Day 1)
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To find reasons for insufficient liver fibrosis assessment
Tidsramme: At the data capture (Day 1)
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This will be assessed via questionnaires. The corresponding questionnaire items investigate whether physicians believe there is insufficient liver fibrosis assessment in current clinical practice. Those who answer affirmatively are then asked to select contributing factors. For patients with confirmed MASLD, physicians are asked: do you think liver fibrosis assessment is currently inadequate in clinical practice? If yes, what are the leading causes of insufficient fibrosis evaluation? Physicians can select from predefined causes, including clinicians paying insufficient attention to liver fibrosis evaluation, low patient acceptance rate of liver biopsy, low diagnostic accuracy of existing noninvasive fibrosis assessment tools, lack of effective pharmacotherapies for liver fibrosis, and others (please specify). There is also an option indicating that there is no inadequate liver fibrosis assessment in clinical practice, which is mutually exclusive with the other options. |
At the data capture (Day 1)
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To investigate importance order of the reasons for insufficient liver fibrosis assessment
Tidsramme: At the data capture (Day 1)
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This will be measured via questionnaires. The corresponding questionnaire items investigate whether physicians believe there is insufficient liver fibrosis assessment in current clinical practice. Those who answer affirmatively are then asked to rank the contributing factors in order of importance. For the selected causes of insufficient fibrosis evaluation, physicians rank each factor based on its importance in contributing to inadequate liver fibrosis assessment in clinical practice. |
At the data capture (Day 1)
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DAS-8853
- U1111-1336-6265 (Annen identifikator: World Health Organization (WHO))
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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