- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Novo Nordisk
- Puhelinnumero: (+1) 866-867-7178
- Sähköposti: clinicaltrials@novonordisk.com
Opiskelupaikat
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Beijing, Kiina
- Rekrytointi
- Novo Nordisk Investigational Site
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
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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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- DAS-8853
- U1111-1336-6265 (Muu tunniste: World Health Organization (WHO))
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
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