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

NCT06121583 | Completed

• 1 other identifier: LAXAP-CASEN-NI 0600
• Study Type: observational
• Target: 449
• Locations: 1 country
• Sites: 14

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.

Conditions

Dietary Deficiency; Sodium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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.

  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

  At the time of the consultation, anticipated average 1 hour

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age greater than or equal to 60 years.

Sponsors & Collaborators

• Casen Recordati S.L.: lead

Study Sites (14)

Centro de Salud Just Oliveras

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Centro de Salud Gracia Sabadell

Sabadell, Barcelona, Spain

Location

Centro de Salud La Barrera

Castro Urdiales, Cantabria, Spain

Location

Consultorio Ojo de Garza

Las Palmas de Gran Canaria, Gran Canaria, Spain

Location

Centro de Salud Reyes Magos

Alcalá de Henares, Madrid, Spain

Location

Centro de Salud Abarán

Abarán, Murcia, Spain

Location

Centro de Salud Cieza Este

Cieza, Murcia, Spain

Location

Centro de Salud Dr. Guigou

Santa Cruz de Tenerife, Tenerife, Spain

Location

Centro de Salud Icod de los Vinos

Santa Cruz de Tenerife, Tenerife, Spain

Location

Centro de Salud Adrià

Barcelona, Spain

Location

Centro de Salud Avenida de Aragón

Madrid, Spain

Location

Centro de Salud Daroca

Madrid, Spain

Location

Centro de Salud Goya

Madrid, Spain

Location

Centro de Salud Potes

Madrid, Spain

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 8, 2023
• Study Start: October 3, 2023
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (14)