Clinical trial NCT06121583: Cross-sectional, Non-randomized Observational Study to Assess the Frequency of Reduced Sodium Intake in the Primary Care Setting - LAXAP
Official title: Cross-sectional, Non-randomized Observational Study to Assess the Frequency of Reduced Sodium Intake in the Primary Care Setting - LAXAP
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dietary Deficiency
Sodium
Lead sponsor: Casen Recordati S.L.
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 449
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (over 60 years of age or older) who attend primary care units

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients who suffer from a condition or take medication associated with a diet low or absent of sodium.
timeFrame: At the time of the consultation, anticipated average 1 hour
Secondary outcomes:
measure: Percentage of patients who present a recommendation/prescription for a low-sodium diet.
timeFrame: At the time of the consultation, anticipated average 1 hour
measure: Percentage of patients with constipation
timeFrame: At the time of the consultation, anticipated average 1 hour
measure: Percentage of patients who take laxatives
timeFrame: At the time of the consultation, anticipated average 1 hour
measure: Percentage of patients who present constipation and suffer from a condition or take medication associated with a diet low or absent of sodium.
timeFrame: At the time of the consultation, anticipated average 1 hour
measure: 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
timeFrame: At the time of the consultation, anticipated average 1 hour
measure: Percentage of patients with each of the diseases or taking treatments that recommend the intake of a diet with low sodium content.
timeFrame: At the time of the consultation, anticipated average 1 hour
measure: Percentage of patients who have sodium restriction in the diet and receive sodium in the form of concomitant medication.
timeFrame: At the time of the consultation, anticipated average 1 hour
measure: Description of each of the study populations
timeFrame: At the time of the consultation, anticipated average 1 hour
measure: Percentage of patients with concomitant medication that may affect the amount of sodium in the blood by type, dosage, duration of treatment
timeFrame: At the time of the consultation, anticipated average 1 hour
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Centro de Salud Just Oliveras
state: Barcelona
city: Sabadell
country: Spain
facility: Centro de Salud Gracia Sabadell
state: Barcelona
city: Las Palmas De Gran Canaria
country: Spain
facility: Consultorio Ojo de Garza
state: Gran Canaria
city: Alcalá De Henares
country: Spain
facility: Centro de Salud Reyes Magos
state: Madrid
city: Abarán
country: Spain
facility: Centro de Salud Abarán
state: Murcia
city: Cieza
country: Spain
facility: Centro de Salud Cieza Este
state: Murcia
city: Castro Urdiales
country: Spain
facility: Centro de Salud La Barrera
state: Santander
city: Santa Cruz De Tenerife
country: Spain
facility: Centro de Salud Dr. Guigou
state: Tenerife
city: Santa Cruz De Tenerife
country: Spain
facility: Centro de Salud Icod de los Vinos
state: Tenerife
city: Barcelona
country: Spain
facility: Centro de Salud Adrià
city: Madrid
country: Spain
facility: Centro de Salud Avenida de Aragón
city: Madrid
country: Spain
facility: Centro de Salud Daroca
city: Madrid
country: Spain
facility: Centro de Salud Goya
city: Madrid
country: Spain
facility: Centro de Salud Potes
Study officials:
References: