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

Completed

• Conditions: Non-alcoholic Steatohepatitis (MASH); Non-alcoholic Fatty Liver Disease (MASLD)
• Interventions: Other: No treatment given

• Registration Number: NCT05765890
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-13
• Study Start: 2023-03-24
• Primary Completion: 2023-09-12
• Study Completion: 2023-09-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 675

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metabolically-Focused HCPs	No treatment given	Recruited via email through online panel companies with which respondents have provided permission to be contacted for research purposes
Hepatologists	No treatment given	Recruited via email through online panel companies with which respondents have provided permission to be contacted for research purposes

Primary Outcome Measures

Name	Time	Method
Unaided awareness	At the time of survey response (Day 1)	Open ended response
Behaviours relative to diagnosing and managing MASLD	At the time of survey response (Day 1)	Numerical, multi-select from defined list
Use of current guidelines	At the time of survey response (Day 1)	Multi-select from defined list; Likert scales; Numerical; Likert scales: 1=Not at all Relevant, 7=Extremely Relevant
Aided awareness	At the time of survey response (Day 1)	Multi- select from defined list
Barriers in guideline adoption	At the time of survey response (Day 1)	Multi-select from defined list; Likert scales; Numerical; Likert scales: 1=Doesn't impact at all, 7=Greatly impacts

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇳 Bangalore, India