Effectiveness of a Mobile Application in Reducing Symptom Recurrence and Improving Quality of Life and Sleep Quality in Patients With Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- GERD Symptom severity
研究概览
简要总结
Gastroesophageal reflux disease (GERD) is a chronic condition with frequent symptom recurrence that may negatively affect sleep quality and quality of life. This randomized controlled study aims to evaluate whether a mobile application developed as a mobile application, combined with standard education and diaphragmatic breathing training, can reduce symptom recurrence and improve sleep quality and quality of life in patients with GERD. Participants will be randomly assigned to either an intervention group receiving the mobile application or a control group receiving standard education. Outcomes will be assessed using the GerdQ, Reflux Symptom Index (RSI), GERD-HRQL, and Insomnia Severity Index (ISI) at baseline, 2 weeks, 4 weeks, and 8 weeks.
详细描述
Gastroesophageal reflux disease (GERD) is one of the most common gastrointestinal disorders and is associated with recurrent symptoms, impaired quality of life, and sleep disturbances. Although proton pump inhibitors are the standard treatment, many patients continue to experience persistent or recurrent symptoms after treatment.
This randomized controlled trial evaluates the effectiveness of a mobile application designed to support self-management in patients with GERD. The intervention includes disease education, lifestyle modification guidance, dietary recommendations, diaphragmatic breathing exercises, and regular reminders delivered through the mobile application in addition to standard education. Participants in the control group receive standard education alone.
The primary objective is to determine whether the intervention reduces symptom recurrence. Secondary objectives are to evaluate improvements in sleep quality and GERD-related quality of life. Outcome measures include the GerdQ, Reflux Symptom Index (RSI), GERD Health-Related Quality of Life (GERD-HRQL), and Insomnia Severity Index (ISI). Assessments are performed at baseline, 2 weeks, 4 weeks, and 8 weeks after enrollment.
The findings of this study may provide evidence supporting the use of mobile health interventions to improve long-term self-management and clinical outcomes in patients with GERD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 60 years.
- •Able to communicate in Mandarin Chinese or Taiwanese.
- •.Owns and is able to use a smartphone.
- •Endoscopically confirmed gastroesophageal reflux disease with Los Angeles (LA) Classification Grade B, C, or D erosive esophagitis, or Barrett's esophagus.
- •Able and willing to provide written informed consent.
排除标准
- •Previous esophageal or gastric surgery, including anti-reflux surgery.
- •Regular use of proton pump inhibitors within the previous 8 weeks.
- •Receiving antithrombotic therapy.
- •Diabetes mellitus requiring treatment (HbA1c ≥ 6.5%).
- •Liver cirrhosis (Child-Pugh class B or higher).
- •Chronic kidney disease stage 3 or higher.
- •Neurological disorders affecting participation.
- •Malignancy other than early-stage cancer.
- •Hiatal hernia larger than 2 cm.
研究组 & 干预措施
Mobile Application + Standard Education
Participants receive standard education plus a study mobile application that provides GERD education, lifestyle modification guidance, dietary recommendations, diaphragmatic breathing exercises, and reminder messages for 4 weeks.
干预措施: Study Mobile Application (Behavioral)
Mobile Application + Standard Education
Participants receive standard education plus a study mobile application that provides GERD education, lifestyle modification guidance, dietary recommendations, diaphragmatic breathing exercises, and reminder messages for 4 weeks.
干预措施: Standard Education (Behavioral)
Standard Education Alone
Participants receive standard education for gastroesophageal reflux disease without access to the study mobile application.
干预措施: Standard Education (Behavioral)
结局指标
主要结局
GERD Symptom severity
时间窗: Baseline, 2 weeks, 4 weeks, and 8 weeks
Change from baseline in gastroesophageal reflux disease symptom severity measured using the GerdQ questionnaire and the Reflux Symptom Index (RSI). The GerdQ total score ranges from 0 to 18, with higher scores indicating more severe gastroesophageal reflux disease symptoms. The RSI total score ranges from 0 to 45, with higher scores indicating more severe reflux symptoms.
次要结局
- GERD-Related Quality of Life(Baseline, 2 weeks, 4 weeks, and 8 weeks)
- Sleep Quality(Baseline, 2 weeks, 4 weeks, and 8 weeks)
研究者
Yi-Hsuan, Liu
Nurse Practitioner
Fooyin University