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OpenTrials
Completed

NCT Number: NCT05765890

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

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.

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Key information

Conditions

Non-alcoholic Steatohepatitis (MASH) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Non-alcoholic Fatty Liver Disease (MASLD)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Bangalore, India

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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:

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):

  • 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:

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

  • 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
  • Does not meet inclusion criteria requirements

Treatment and study plan

No treatment given

Other

No treatment given

Primary outcomes

  1. Unaided awareness

    Time frame: At the time of survey response (Day 1)

    Open ended response

  2. Aided awareness

    Time frame: At the time of survey response (Day 1)

    Multi- select from defined list

  3. Behaviours relative to diagnosing and managing MASLD

    Time frame: At the time of survey response (Day 1)

    Numerical, multi-select from defined list

  4. Use of current guidelines

    Time frame: 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

  5. Barriers in guideline adoption

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Acronym: BARRIERS-MASLD

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2023
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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