Cross-sectional, Non-randomized Observational Study to Assess the Frequency of Reduced Sodium Intake in the Primary Care Setting - LAXAP

Completed

• Conditions: Dietary Deficiency; Sodium

• Registration Number: NCT06121583
• Lead Sponsor: Casen Recordati S.L.

Brief Summary

This study is a cross-sectional epidemiological, observational study. It would be carried out in primary health care sites. The purpose of this study is estimating the percentage of patients aged 60 years or older who suffer from a condition, or take medication, associated with a low or sodium-free diet in primary care consultations.

This is a cross-sectional epidemiological study of data collection without medication.

Participants data will be collected after obtaining their confirmation through an Informed Consent From. No medication will be given to patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-03
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-08
• Primary Completion: 2023-12-29
• Study Completion: 2023-12-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 449

Inclusion Criteria

• Patients seen in the primary care unit, in person, with inclusion beginning in order of care in consultation from the beginning of the study.
• Age greater than or equal to 60 years.

Exclusion Criteria

Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients who suffer from a condition or take medication associated with a diet low or absent of sodium.	At the time of the consultation, anticipated average 1 hour	Patients who require to follow a diet with low sodium content defined as patients that suffer from a condition or take medication associated with a diet low or absent of sodium: Right or congestive heart failure, Acute kidney failure, Chronic renal failure, Nephrotic syndrome, Edematogenic glomerulonephritis, Diabetic nephropathy, Nephrolithiasis, Arterial hypertension, Ascites, Hepatic cirrhosis, Prolonged treatments (more than 6 months) with corticosteroids

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who present a recommendation/prescription for a low-sodium diet.	At the time of the consultation, anticipated average 1 hour
Percentage of patients with constipation	At the time of the consultation, anticipated average 1 hour	Constipation according to Rome III: a diagnosis of functional constipation is made when at least two of the following criteria are met for the last 3 months with symptom onset at least 6 months prior to diagnosis: a) straining on \>25% of defecations; b) lumpy or hard stools on \>25% of defecations; c) sensation of incomplete evacuation on \>25% of defecations; d) sensation of anorectal obstruction/blockage on \>25% of defecations; e) manual maneuvers on \>25% of defecations; and f) less than 3 defecations per week.
Percentage of patients who take laxatives	At the time of the consultation, anticipated average 1 hour
Description of each of the study populations	At the time of the consultation, anticipated average 1 hour	Description of patients who suffer from a condition or take a medication associated with a low or no sodium diet, patients with a low sodium diet recommendation, patients with constipation, patients taking laxatives: Data demographics, anthropometric data, diseases associated with a low sodium diet, constipation, laxatives and concomitant medication. In terms of their demographics and clinical characteristics.
Percentage of patients who present constipation and suffer from a condition or take a medication associated with a low or absent sodium diet and receive a prescription for a laxative with a high level of sodium	At the time of the consultation, anticipated average 1 hour	Constipation according to Rome III: a diagnosis of functional constipation is made when at least two of the following criteria are met for the last 3 months with symptom onset at least 6 months prior to diagnosis: a) straining on \>25% of defecations; b) lumpy or hard stools on \>25% of defecations; c) sensation of incomplete evacuation on \>25% of defecations; d) sensation of anorectal obstruction/blockage on \>25% of defecations; e) manual maneuvers on \>25% of defecations; and f) less than 3 defecations per week.; Patients who require to follow a diet with low sodium content defined as patients that suffer from a condition or take medication associated with a diet low or absent of sodium: Right or congestive heart failure, Acute kidney failure, Chronic renal failure, Nephrotic syndrome, Edematogenic glomerulonephritis, Diabetic nephropathy, Nephrolithiasis, Arterial hypertension, Ascites, Hepatic cirrhosis, Prolonged treatments (more than 6 months) with corticosteroids
Percentage of patients with concomitant medication that may affect the amount of sodium in the blood by type, dosage, duration of treatment	At the time of the consultation, anticipated average 1 hour
Percentage of patients who present constipation and suffer from a condition or take medication associated with a diet low or absent of sodium.	At the time of the consultation, anticipated average 1 hour	Constipation according to Rome III: a diagnosis of functional constipation is made when at least two of the following criteria are met for the last 3 months with symptom onset at least 6 months prior to diagnosis: a) straining on \>25% of defecations; b) lumpy or hard stools on \>25% of defecations; c) sensation of incomplete evacuation on \>25% of defecations; d) sensation of anorectal obstruction/blockage on \>25% of defecations; e) manual maneuvers on \>25% of defecations; and f) less than 3 defecations per week.; Patients who require to follow a diet with low sodium content defined as patients that suffer from a condition or take medication associated with a diet low or absent of sodium: Right or congestive heart failure, Acute kidney failure, Chronic renal failure, Nephrotic syndrome, Edematogenic glomerulonephritis, Diabetic nephropathy, Nephrolithiasis, Arterial hypertension, Ascites, Hepatic cirrhosis, Prolonged treatments (more than 6 months) with corticosteroids
Percentage of patients with each of the diseases or taking treatments that recommend the intake of a diet with low sodium content.	At the time of the consultation, anticipated average 1 hour	Patients that suffer from a condition or take medication associated with a diet low or absent of sodium: Right or congestive heart failure, Acute kidney failure, Chronic renal failure, Nephrotic syndrome, Edematogenic glomerulonephritis, Diabetic nephropathy, Nephrolithiasis, Arterial hypertension, Ascites, Hepatic cirrhosis, Prolonged treatments (more than 6 months) with corticosteroids
Percentage of patients who have sodium restriction in the diet and receive sodium in the form of concomitant medication.	At the time of the consultation, anticipated average 1 hour

Trial Locations

Locations (14)

Centro de Salud Avenida de Aragón; 🇪🇸 Madrid, Spain

Centro de Salud La Barrera; 🇪🇸 Castro Urdiales, Santander, Spain

Centro de Salud Adrià; 🇪🇸 Barcelona, Spain

Centro de Salud Dr. Guigou; 🇪🇸 Santa Cruz De Tenerife, Tenerife, Spain

Centro de Salud Reyes Magos; 🇪🇸 Alcalá De Henares, Madrid, Spain

Consultorio Ojo de Garza; 🇪🇸 Las Palmas De Gran Canaria, Gran Canaria, Spain

Centro de Salud Abarán; 🇪🇸 Abarán, Murcia, Spain

Centro de Salud Icod de los Vinos; 🇪🇸 Santa Cruz De Tenerife, Tenerife, Spain

Centro de Salud Goya; 🇪🇸 Madrid, Spain

Centro de Salud Daroca; 🇪🇸 Madrid, Spain

Centro de Salud Potes; 🇪🇸 Madrid, Spain

Centro de Salud Gracia Sabadell; 🇪🇸 Sabadell, Barcelona, Spain

Centro de Salud Cieza Este; 🇪🇸 Cieza, Murcia, Spain

Centro de Salud Just Oliveras; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain