Clinical trial NCT05765890: Barriers to MASLD Management in Europe: Findings From a Multidisciplinary HCP-survey
Official title: Barriers to MASLD Management in Europe: Findings From a Multidisciplinary HCP-survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-alcoholic Steatohepatitis (MASH)
Non-alcoholic Fatty Liver Disease (MASLD)
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 675
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatologists and other metabolically focused healthcare providers (HCPs)

Brief summary: The purpose of this study is to better understand the main barriers to earlier diagnosis and better management of MASLD/MASH patients and to understand the key barriers to adoption of guidelines.

This study is a cross-sectional design, conducted across 5 countries in Europe- France, Germany, Spain, United Kingdom (UK), Italy. Study participants, Hepatologists and other metabolically focused healthcare providers (HCPs), will be recruited to complete a 15 minute self-administered online survey.


Eligibility criteria: Inclusion Criteria:

For Hepatologists:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age above or equal to 18 years at the time of signing informed consent.
3. Is a physician
4. Lives in UK, France, Germany, Italy or Spain
5. Primary medical specialty is:

5.a. Hepatology or 5.b. Gastroenterology or Internal Medicine with a subspecialty in Hepatology 6. In practice at least 3 years 7. Spends at least 50 percent of their time in an office/clinic setting 8. Spends at least 60 percent of their time in direct patient care 9. Sees at least 15 patients/month with MASH/MASLD

For Metabolically-Focused HCPs (Endocrinologist/General Physician/Family Physician/Internal Medicine):

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age above or equal to 18 years at the time of signing informed consent.
3. Is a physician
4. Lives in UK, France, Germany, Italy or Spain
5. Primary medical specialty is:

5.a. General Physician/Family Practitioner or Endocrinology or 5.b. Internal Medicine without subspecialty in Hepatology 6. In practice at least 3 years 7. Spends less than 50 percent of their time in an office/clinic setting 8. Spends less than 60 percent of their time in direct patient care 9. Sees at least 15 patients/month with suspected/diagnosed MASH/MASLD 10. Sees and actively treats at least 30 patients/month with Type 2 Diabetes (T2D) and/or Obesity

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Does not meet inclusion criteria requirements

Primary outcomes:
measure: Unaided awareness
timeFrame: At the time of survey response (Day 1)
measure: Aided awareness
timeFrame: At the time of survey response (Day 1)
measure: Behaviours relative to diagnosing and managing MASLD
timeFrame: At the time of survey response (Day 1)
measure: Use of current guidelines
timeFrame: At the time of survey response (Day 1)
measure: Barriers in guideline adoption
timeFrame: At the time of survey response (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: