Implementation of the Fatty Liver Index in Primary Care
- Conditions
- Overweight and ObesityHepatic Steatosis
- Interventions
- Other: FLI
- Registration Number
- NCT06363617
- Lead Sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 434
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FLI test implementation FLI 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.
- Primary Outcome Measures
Name Time Method Lifestyle Intervention Month 6 Percentage of participants receiving a lifestyle intervention from the start of the study to month 6
- Secondary Outcome Measures
Name Time Method FLI administration Month 12 Percentage of patients with body mass index equal or more than 25 who have been administered the FLI
Analytical checks in the first year Month 12 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.
Medical and nursing visits Month 12 Number of medical and nursing visits in the year following the intervention.
Triglycerides Month 12 Value of triglycerides in analyses performed between 6 months and one year post-intervention
Gamma-glutamyl transpeptidase Month 12 Value of gamma-glutamyl transpeptidase in analyses performed between 6 months and one year post-intervention
Low-density lipoprotein cholesterol Month 12 Value of low-density lipoprotein cholesterol (LDL cholesterol) in analyses performed between 6 months and one year post-intervention
Lipid-lowering drugs Month 12 Number of prescriptions for lipid-lowering drugs.
Healthcare spending Month 12 Analysis of healthcare spending associated with each intervention, using billing data from the center associated with the use of resources by the insured party.
Trial Locations
- Locations (1)
Centro de Salud Vilanova i la Geltrú 3 Baix A Mar
🇪🇸Vilanova I La Geltrú, Barcelona, Spain