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

• Conditions: Reflux

• Registration Number: NCT05162079
• Lead Sponsor: Universidad Miguel Hernandez de Elche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-16
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-16
• Last Update Submitted: 2021-12-16
• Study First Posted: 2021-12-17
• Last Update Posted: 2021-12-17
• Study Start: 2022-03-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collection of sociodemographic data of participants	8 minutes each questionnaire	At the initial visit, sociodemographic variables will be collected through a Data Collection Notebook (CDR): sex, age, level of education, employment status, civil status.
Detail the evolution of the patient's symptoms 14 days after intervention	5 minutes	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)
Collection of clinical data of participants	8 minutes each questionnaire	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
Evaluate patient satisfaction	5 minutes	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)