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

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.

Study Overview

• Status: Completed
• Conditions: Dietary Deficiency; Sodium

• Study Type: Observational
• Enrollment (Actual): 449

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Centro de Salud Adrià
  • Madrid, Spain
    • Centro de Salud Avenida de Aragón
  • Madrid, Spain
    • Centro de Salud Daroca
  • Madrid, Spain
    • Centro de Salud Goya
  • Madrid, Spain
    • Centro de Salud Potes
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain
      • Centro de Salud Just Oliveras
    • Sabadell, Barcelona, Spain
      • Centro de Salud Gracia Sabadell
  • Gran Canaria
    • Las Palmas De Gran Canaria, Gran Canaria, Spain
      • Consultorio Ojo de Garza
  • Madrid
    • Alcalá De Henares, Madrid, Spain
      • Centro de Salud Reyes Magos
  • Murcia
    • Abarán, Murcia, Spain
      • Centro de Salud Abarán
    • Cieza, Murcia, Spain
      • Centro de Salud Cieza Este
  • Santander
    • Castro Urdiales, Santander, Spain
      • Centro de Salud La Barrera
  • Tenerife
    • Santa Cruz De Tenerife, Tenerife, Spain
      • Centro de Salud Dr. Guigou
    • Santa Cruz De Tenerife, Tenerife, Spain
      • Centro de Salud Icod de los Vinos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (over 60 years of age or older) who attend primary care units

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients who suffer from a condition or take medication associated with a diet low or absent of sodium.	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	At the time of the consultation, anticipated average 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	At the time of the consultation, anticipated average 1 hour
Percentage of patients who take laxatives		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.	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	At the time of the consultation, anticipated average 1 hour
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	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	At the time of the consultation, anticipated average 1 hour
Percentage of patients with each of the diseases or taking treatments that recommend the intake of a diet with low sodium content.	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	At the time of the consultation, anticipated average 1 hour
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
Description of each of the study populations	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.	At the time of the consultation, anticipated average 1 hour
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

Collaborators and Investigators

• Sponsor: Casen Recordati S.L.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

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

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: LAXAP-CASEN-NI 0600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: there is no IMPD object of the study

Drug and device information, study documents

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