Barriers to MASLD Management in Europe: Findings From a Multidisciplinary HCP-survey

NCT05765890 | Completed

• 2 other identifiers: DAS-7671U1111-1284-5875
• Study Type: observational
• Target: 675
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Steatohepatitis (MASH); Non-alcoholic Fatty Liver Disease (MASLD)

Outcome Measures

Primary Outcomes (5)

• Unaided awareness

  Open ended response

  At the time of survey response (Day 1)

• Aided awareness

  Multi- select from defined list

  At the time of survey response (Day 1)

• Behaviours relative to diagnosing and managing MASLD

  Numerical, multi-select from defined list

  At the time of survey response (Day 1)

• Use of current guidelines

  Multi-select from defined list; Likert scales; Numerical Likert scales: 1=Not at all Relevant, 7=Extremely Relevant

  At the time of survey response (Day 1)

• Barriers in guideline adoption

  Multi-select from defined list; Likert scales; Numerical Likert scales: 1=Doesn't impact at all, 7=Greatly impacts

  At the time of survey response (Day 1)

Study Arms (2)

Hepatologists

Recruited via email through online panel companies with which respondents have provided permission to be contacted for research purposes

Other: No treatment given

Metabolically-Focused HCPs

Recruited via email through online panel companies with which respondents have provided permission to be contacted for research purposes

Other: No treatment given

Interventions

No treatment given OTHER

No treatment given

Hepatologists; Metabolically-Focused HCPs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hepatologists and other metabolically focused healthcare providers (HCPs)

You may qualify if:

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

You may not qualify if:

• Previous participation in this study. Participation is defined as having given informed consent in this study
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Bangalore, India

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 13, 2023
• Study Start: March 24, 2023
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)