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

NCT ID: NCT05162079

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-09-01

Brief Summary

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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

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Conditions

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Reflux

Keywords

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HEARTBURN, DYSPEPSIA, REFLUX, PHARMACY

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

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Elsa López Pintor

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 39713795 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36011453 (View on PubMed)

Other Identifiers

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SEFAC1.20I.

Identifier Type: -

Identifier Source: org_study_id