Implementation of the Fatty Liver Index in Primary Care (FLI-AP)

Implementation of the Fatty Liver Index in Primary Care for Patients at Risk of Hepatic Steatosis to Optimize Clinical Control: Randomized Clinical Trial

This trial aims to evaluate the impact on cardiovascular risk control in individuals in risk of being affected by hepatic steatosis through the implementation of a screening test (Fatty Liver Index) in Primary Care. Medical teams in a primary care center will be divided into 2 groups, with one group using the screening test in their clinical practice. The number of interventions on cardiovascular risk occurring in patients attended by each group of medical teams will be evaluated and compared.

Study Overview

• Status: Not yet recruiting
• Conditions: Overweight and Obesity; Hepatic Steatosis
• Intervention / Treatment: Other: FLI

• Study Type: Interventional
• Enrollment (Estimated): 434
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noemí Casaponsa; Phone Number: 43197 +34 938960025; Email: recerca@csapg.cat
• Study Contact Backup: Name: M Carmen Rosas, MD; Phone Number: +34 938 10 30 03; Email: mrosas@csapg.cat

Study Locations

• Spain
  • Barcelona
    • Vilanova I La Geltrú, Barcelona, Spain
      • Centro de Salud Vilanova i la Geltrú 3 Baix A Mar
      • Contact: M Carmen Rosas, MD; Phone Number: +34 938 10 30 03; Email: mrosas@csapg.cat
      • Contact: Noemí Casaponsa; Phone Number: 43197 +34 938960026; Email: recerca@csapg.cat
      • Principal Investigator: M Carmen Rosas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men and women aged 14 years and older.
• Attended at the Basic Care Units (BCU) participating in the Primary Care Center Baix a Mar study.
• Intention to undergo medical follow-up at the study center.
• Body mass index ≥ 25.

Exclusion Criteria:

• Pregnant women
• Alcohol consumption habit (Standard Drink Unit (SDU); one SDU equals 10 grams of alcohol. Risky consumption is considered from 4 SDUs in men and 2 SDUs in women).
• Displaced patients not assigned to the study center.
• Patients classified as Advanced Chronic Care Model or Complex Chronic Patient.
• Participants diagnosed with any of the following pathologies: Chronic liver diseases, including hepatic steatosis; Dementia; Active oncological diseases
• Cognitive or affective pathology that limits the ability to collaborate with lifestyle interventions carried out at the center.
• Patients under the care of endocrinology specialists.
• Participation in another clinical trial involving an experimental intervention during the period of this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FLI test implementation; A training session will be conducted for healthcare professionals on the risks of hepatic steatosis in patients with a body mass index (BMI) equal to or greater than 25. Additionally, professionals will be instructed in the use of the Fatty Liver Index (FLI) tool, validated for assessing the risk of steatosis. This tool will be implemented in the center's computer system, making it accessible via a link for the professionals receiving the intervention.	Other: FLI; Health professionals will use the FLI test in their clinical practice
No Intervention: control; This group of healthcare professionals will continue with their usual clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lifestyle Intervention	Percentage of participants receiving a lifestyle intervention from the start of the study to month 6	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low-density lipoprotein cholesterol	Value of low-density lipoprotein cholesterol (LDL cholesterol) in analyses performed between 6 months and one year post-intervention	Month 12
Gamma-glutamyl transpeptidase	Value of gamma-glutamyl transpeptidase in analyses performed between 6 months and one year post-intervention	Month 12
Medical and nursing visits	Number of medical and nursing visits in the year following the intervention.	Month 12
Analytical checks in the first year	Percentage of patients who had not undergone previous analytical checks according to protocol and who undergo analysis in the first year after the start of the study.	Month 12
Lipid-lowering drugs	Number of prescriptions for lipid-lowering drugs.	Month 12
Healthcare spending	Analysis of healthcare spending associated with each intervention, using billing data from the center associated with the use of resources by the insured party.	Month 12
Triglycerides	Value of triglycerides in analyses performed between 6 months and one year post-intervention	Month 12
FLI administration	Percentage of patients with body mass index equal or more than 25 who have been administered the FLI	Month 12

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
• Investigators: Principal Investigator: M Carmen Rosas, MD, CSAPG

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Overnutrition; Nutrition Disorders; Body Weight; Fatty Liver; Overweight
• Other Study ID Numbers: CSAPG-58

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
• IPD Sharing Time Frame: After publication of main results of the study.
• IPD Sharing Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

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