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

NCT05162079 | Unknown

• 1 other identifier: SEFAC1.20I.
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Reflux

Keywords

HEARTBURN, DYSPEPSIA, REFLUX, PHARMACY

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Eligibility Criteria

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

Study Population

Spanish patients who visit the pharmacies asking for advice of acid-reflux symptoms or requesting non-prescription medication for it

You may qualify if:

• Population´s age ≥ 18 years
• Patients who consult for mild symptoms of heartburn and/or gastroesophageal reflux or request treatment for it.

You may not qualify if:

• Subjects who request treatment for symptoms of heartburn and/or gastroesophageal reflux for another person
• Women with high-risk pregnancies

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Related Publications (2)

• Puig-Molto M, Lumbreras B, Lopez-Pintor E. Improving Proton-Pump Inhibitor Adherence Intervention Between Primary Care and Community Pharmacies: A Pre-Post Intervention Study. Patient Prefer Adherence. 2024 Dec 18;18:2569-2580. doi: 10.2147/PPA.S485307. eCollection 2024.

  PMID: 39713795 DERIVED

• Lopez-Pintor E, Puig-Molto M, Lumbreras B. EsReflux Protocol: Epidemiological Study of Heartburn and Reflux-like Symptoms in Spanish Community Pharmacies. Int J Environ Res Public Health. 2022 Aug 9;19(16):9807. doi: 10.3390/ijerph19169807.

  PMID: 36011453 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn; Dyspepsia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 17, 2021
• Study Start: March 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 17, 2021

Record last verified: 2021-12