Evaluating Medication Adherence of Patients With Gastroesophageal Reflux Disease With Support of the Smartphone Application GERDCare
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Proportion of patients with good adherence at 4 weeks
研究概览
简要总结
Adherence to GERD treatment, including medication, diet, and lifestyle, is essential for symptom control and complication prevention, yet adherence rates remain low due to various demographic and clinical factors. Digital therapeutics, particularly mobile health applications, have shown promising potential in supporting chronic disease management and improving patient outcomes.
The GERDCare mobile application was developed with direct input from gastrointestinal experts. It is designed to enhance treatment adherence and patient engagement by offering features such as educational resources, symptom tracking, medication reminders, and direct communication between patients and physicians.
The investigators are conducting a single-center, open-label, randomized controlled trial to evaluate the effectiveness of using GERDCare in improving patient adherence. Patients are followed up after four weeks of GERD treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Presents with typical GERD symptoms (regurgitation, heartburn)
- •Owns a smartphone and capable of using smartphone applications.
排除标准
- •Acute GI conditions (upper GI bleeding, acute peptic ulcer…)
- •GI malignancy (esophageal cancer, gastric cancer…)
- •Severe chronic comorbidities (heart failure, liver failure, chronic kidney disease…)
- •Pregnancy, alcohol abuse, mental health conditions impacting medication adherence or app usage
研究组 & 干预措施
Using GERDCare
Using the mobile phone application GERDCare (with detailed instructions provided during recruitment)
干预措施: GERCCare mobile app (Other)
Not using GERDCare
Not using the smartphone application GERDCare
结局指标
主要结局
Proportion of patients with good adherence at 4 weeks
时间窗: 4 weeks after recruitment
Patients achieved a score of ≥27 points on the Vietnamese Version of the General Medication Adherence Scale (GMAS). Higher scores mean better adherence.
次要结局
- Changes of patients' quality of life after 4 weeks(4 weeks after recruitment)
- Changes in GERD symptom severity(4 weeks after recruitment)
- Proportion of patients with clinical improvement after 4 weeks(4 weeks after recruitment)
- Changes of patients' quality of life after 4 weeks(4 weeks after recruitment)