RefluxES-REFLUJONCT05162079
Protocol for the ESREFLUJO Study: Epidemiological Study of Heartburn and Gastroesophageal Reflux in Community Pharmacy
An observational study of Reflux, run by Universidad Miguel Hernandez de Elche.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reflux
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- 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
Who may be able to join
- Population´s age ≥ 18 years
- Patients who consult for mild symptoms of heartburn and/or gastroesophageal reflux or request treatment for it.
Who cannot join
- Subjects who request treatment for symptoms of heartburn and/or gastroesophageal reflux for another person
- Women with high-risk pregnancies
About this study
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
- Medical subject headings
- Gastroesophageal Reflux, Heartburn, Dyspepsia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 Mar 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsa López Pintor, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162079
- Sponsor's protocol ID
- SEFAC1.20I.
- Acronym
- ES-REFLUJO
- Status last verified
- Dec 2021
- First submitted
- 16 Nov 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39713795Lopez-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.
PubMed 36011453
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the ESREFLUJO Study: Epidemiological Study of Heartburn and Gastroesophageal Reflux in Community Pharmacy
- ClinicalTrials.gov ID
- NCT05162079
- Acronym / sponsor ID
- ES-REFLUJO / SEFAC1.20I.
- Conditions
- Reflux
- Keywords
- HEARTBURN, DYSPEPSIA, REFLUX, PHARMACY
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- Population´s age ≥ 18 years
- Patients who consult for mild symptoms of heartburn and/or gastroesophageal reflux or request treatment for it.
Key exclusion criteria (2 listed)
- Subjects who request treatment for symptoms of heartburn and/or gastroesophageal reflux for another person
- Women with high-risk pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collection of sociodemographic data of participants
Time frame: 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.
Collection of clinical data of participants
Time frame: 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
Detail the evolution of the patient's symptoms 14 days after intervention
Time frame: 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)
Evaluate patient satisfaction
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Derived from this study: PubMed 39713795Puig-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.
- Derived from this study: PubMed 36011453Lopez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Reflux, run by Universidad Miguel Hernandez de Elche.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of sociodemographic data of participants (time frame: 8 minutes each questionnaire). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05162079, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.