Protocol for the ESREFLUJO Study: Epidemiological Study of Heartburn and Gastroesophageal Reflux in Community Pharmacy
试验速览
- 阶段
- 不适用
- 入组人数
- 1,200
- 主要终点
- Collection of sociodemographic data of participants
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Population´s age ≥ 18 years
- •Patients who consult for mild symptoms of heartburn and/or gastroesophageal reflux or request treatment for it.
排除标准
- •Subjects who request treatment for symptoms of heartburn and/or gastroesophageal reflux for another person
- •Women with high-risk pregnancies
结局指标
主要结局
Collection of sociodemographic data of participants
时间窗: 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.
Detail the evolution of the patient's symptoms 14 days after intervention
时间窗: 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)
Collection of clinical data of participants
时间窗: 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
Evaluate patient satisfaction
时间窗: 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)
次要结局
未报告次要终点
研究者
Elsa López Pintor
Lecturer
Universidad Miguel Hernandez de Elche