- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Novo Nordisk
- Telefonní číslo: (+1) 866-867-7178
- E-mail: clinicaltrials@novonordisk.com
Studijní místa
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Beijing, Čína
- Nábor
- Novo Nordisk Investigational site
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- DAS-8853
- U1111-1336-6265 (Jiný identifikátor: World Health Organization (WHO))
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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