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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05765890
• Collaborator: (none)
• Enrollment: 625
• Location: 1
• Anticipated Duration (Days): 28
• Patients Per Site Per Month: 679.4

Study Details

Study Description

Brief Summary

The purpose of this study is to better understand the main barriers to earlier diagnosis and better management of NAFLD/NASH 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.

Condition or Disease	Intervention/Treatment	Phase
Non-alcoholic Steatohepatitis; Non-alcoholic Fatty Liver Disease	Other: No treatment given

Study Design

• Study Type: Observational
• Anticipated Enrollment: 625 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Barriers to NAFLD Management in Europe: Findings From a Multidisciplinary HCP-survey
• Anticipated Study Start Date: Mar 13, 2023
• Anticipated Primary Completion Date: Apr 10, 2023
• Anticipated Study Completion Date: Apr 10, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Unaided awareness [At the time of survey response (Day 1)]

   Open ended response

2. Aided awareness [At the time of survey response (Day 1)]

   Multi- select from defined list

3. Behaviours relative to diagnosing and managing NASH [At the time of survey response (Day 1)]

   Numerical, multi-select from defined list

4. 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

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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 Nonalcoholic steatohepatitis (NASH) / Non-alcoholic fatty liver disease (NAFLD)

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 NAFLD/NASH 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Bangalore		India

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT05765890
• Other Study ID Numbers: DAS-7671; U1111-1284-5875
• First Posted: Mar 13, 2023
• Last Update Posted: Mar 13, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Mar 13, 2023