## Protocol Section
### Identification Module
**NCT ID:** NCT05162079

**Acronym:** ES-REFLUJO

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

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

#### Organization Study ID Info
**ID:** SEFAC1.20I.
#### Organization
**Class:** OTHER
**Full Name:** Universidad Miguel Hernandez de Elche
### Status Module
#### Completion Date
**Date:** 2022-09-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2021-12-17

**Type:** ACTUAL

**Last Update Submit Date:** 2021-12-16

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-03-01

**Type:** ESTIMATED

**Status Verified Date:** 2021-12

#### Study First Post Date
**Date:** 2021-12-17
**Type:** ACTUAL
**Study First Submit Date:** 2021-11-16
**Study First Submit QC Date:** 2021-12-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universidad Miguel Hernandez de Elche

#### Responsible Party

**Investigator Affiliation:** Universidad Miguel Hernandez de Elche

**Investigator Full Name:** Elsa López Pintor

**Investigator Title:** Lecturer

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Reflux

**Keywords:**

- HEARTBURN, DYSPEPSIA, REFLUX, PHARMACY

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1200

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** At the initial visit, sociodemographic variables will be collected through a Data Collection Notebook (CDR): sex, age, level of education, employment status, civil status.

**Measure:** Collection of sociodemographic data of participants

**Time Frame:** 8 minutes each questionnaire

**Description:** 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

**Measure:** Collection of clinical data of participants

**Time Frame:** 8 minutes each questionnaire

**Description:** 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)

**Measure:** Detail the evolution of the patient's symptoms 14 days after intervention

**Time Frame:** 5 minutes

**Description:** 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)

**Measure:** Evaluate patient satisfaction

**Time Frame:** 5 minutes

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### References Module

#### References

**Citation:** 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 Section

### Condition Browse Module - Ancestors

- ID: D000015154

- Term: Esophageal Motility Disorders

- ID: D000003680

- Term: Deglutition Disorders

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000012817

- Term: Signs and Symptoms, Digestive

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

### Condition Browse Module - Browse Leaves

- ID: M7589

- Name: Dyspepsia

- Relevance: LOW

- As Found: Unknown

- ID: M8880

- Name: Gastroesophageal Reflux

- Relevance: HIGH

- As Found: Gastroesophageal Reflux

- ID: M9444

- Name: Heartburn

- Relevance: HIGH

- As Found: Heartburn

- ID: M17874

- Name: Esophageal Motility Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17875

- Name: Esophageal Spasm, Diffuse

- Relevance: LOW

- As Found: Unknown

- ID: M6882

- Name: Deglutition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M8085

- Name: Esophageal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005764

- Term: Gastroesophageal Reflux

- ID: D000006356

- Term: Heartburn

### Misc Info Module

- Version Holder: 2024-05-24
