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

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.

Study Overview

• Status: Completed
• Conditions: Non-alcoholic Steatohepatitis (MASH); Non-alcoholic Fatty Liver Disease (MASLD)
• Intervention / Treatment: Other: No treatment given

• Study Type: Observational
• Enrollment (Actual): 675

Contacts and Locations

Study Locations

• India
  • Bangalore, India
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Hepatologists and other metabolically focused healthcare providers (HCPs)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hepatologists; Recruited via email through online panel companies with which respondents have provided permission to be contacted for research purposes	Other: No treatment given; 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; No treatment given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Behaviours relative to diagnosing and managing MASLD	Numerical, multi-select from defined list	At the time of survey response (Day 1)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2023
• Primary Completion (Actual): September 12, 2023
• Study Completion (Actual): September 12, 2023

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: DAS-7671; U1111-1284-5875 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No