An observational study in Reflux, sponsored by Universidad Miguel Hernandez de Elche. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-17.
Sponsored by Universidad Miguel Hernandez de Elche · Observational
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.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 178 across 348 observational studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Universidad Miguel Hernandez de Elche is the lead sponsor of 87 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Spanish patients who visit the pharmacies asking for advice of acid-reflux symptoms or requesting non-prescription medication for it
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 5 minutes
No study locations are listed for this record.
Start is estimated for Mar 2022; primary completion for Jul 2022, 4 months later.
Of 95 non-industry observational studies under Gastroesophageal Reflux, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 167. This study's planned 4 months is below that.
Counting every sponsor, half of 116 studies reached it within 45 months; a quarter within 17 and three quarters within 167.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Universidad Miguel Hernandez de Elche