Protocol for the ESREFLUJO Study: Epidemiological Study of Heartburn and Gastroesophageal Reflux in Community Pharmacy

Reflux Clinical Trial

— ES-REFLUJO  

Official title:

Protocol for the ESREFLUJO Study: Epidemiological Study of Heartburn and Gastroesophageal Reflux in Community Pharmacy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05162079
• Other study ID #: SEFAC1.20I.
• Status: Not yet recruiting
• Start date: March 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: December 2021
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Introduction: Symptoms as heartburn and/or reflux is frequent consultations in community pharmacies, the characterization of them is crucial to provide appropriate patient counseling. To facilitate the assistance work of the community pharmacist and its coordination between different levels of care, a group of experts in Community Pharmacy, Primary Care, and Gastroenterology has recently worked on an algorithm to manage these symptoms.

Objective: Analyse the epidemiological characteristics of patients who consult for symptoms of heartburn and/or reflux in Spanish community pharmacies, and evaluate the clinical and humanistic results of the protocolization of a Professional Pharmaceutical Service in said patients.

Methods and analysis: The study design consists of a cross-sectional descriptive part, in which the clinical and sociodemographic characteristics of the patients who come to the community pharmacy will be evaluated for consultation derived from heartburn and/or reflux symptoms and a before-after descriptive study in which will evaluate the clinical and humanistic results in patients who come to the pharmacy after receiving pharmaceutical care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: September 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Population´s age = 18 years

• Patients who consult for mild symptoms of heartburn and/or gastroesophageal reflux or request treatment for it.

Exclusion Criteria:

• Subjects who request treatment for symptoms of heartburn and/or gastroesophageal reflux for another person

• Women with high-risk pregnancies

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Heartburn
• Reflux

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of sociodemographic data of participants	At the initial visit, sociodemographic variables will be collected through a Data Collection Notebook (CDR): sex, age, level of education, employment status, civil status.	8 minutes each questionnaire
Primary	Collection of clinical data of participants	At the initial visit, clinical data will be collected through a Data Collection Notebook (CDR): Risk factors: Body mass index (BMI), smoking, food consumption; • Weight and height will be combined to report BMI in kg/m^2.; Symptoms throught the questionnaire: The Gastro-oesophageal Reflux Disease Impact Scale (GIS); Treatments or medications used	8 minutes each questionnaire
Primary	Detail the evolution of the patient's symptoms 14 days after intervention	An independent external monitor will make a telephone call to each patient to collect the evolution of the patient´s symptoms through a questionnaire: The Gastro-oesophageal Reflux Disease Impact Scale (GIS). It is a scale of frequency, the lower scores mean better health in the patient less frequency of disturbances)	5 minutes
Primary	Evaluate patient satisfaction	An independent external monitor will make a telephone call to each patient to collect the evolution of the patient´s symptoms through a questionnaire: Degree of satisfaction with the pharmaceutical care received (The score is the level of agreement, high punctuation means more satisfaction) and If the patient gets medication: Treatment Satisfaction Questionnaire for Medication (TSMQ, v1.4). (The score is the level of satisfaction, high punctuation means more satisfaction)	5 minutes