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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLI test implementation | Experimental | 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. |
|
| control | No Intervention | This group of healthcare professionals will continue with their usual clinical practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLI | Other | Health professionals will use the FLI test in their clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lifestyle Intervention | Percentage of participants receiving a lifestyle intervention from the start of the study to month 6 | Month 6 |
| 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 |
| Triglycerides |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M Carmen Rosas, MD | CSAPG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud Vilanova i la Geltrú 3 Baix A Mar | Vilanova i la Geltrú | Barcelona | Spain |
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).
After publication of main results of the study.
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.
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Value of triglycerides 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 |
| FLI administration | Percentage of patients with body mass index equal or more than 25 who have been administered the FLI | Month 12 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |