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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Participants receive a study mobile application providing gastroesophageal reflux disease education, lifestyle modification guidance, dietary recommendations, diaphragmatic breathing exercises, and reminder messages for 4 weeks.
Participants receive standard education for gastroesophageal reflux disease.
Yuan's General Hospital
Kaohsiung City, Taiwan
GERD Symptom severity
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.
Time frame: Baseline, 2 weeks, 4 weeks, and 8 weeks
GERD-Related Quality of Life
Change in gastroesophageal reflux disease-related quality of life measured using the GERD-HRQL. The total score ranges from 0 to 50, with higher scores indicating worse GERD-related quality of life.
Time frame: Baseline, 2 weeks, 4 weeks, and 8 weeks
Sleep Quality
Change in sleep quality measured using the Insomnia Severity Index (ISI). The total score ranges from 0 to 28, with higher scores indicating worse sleep quality (more severe insomnia).
Time frame: Baseline, 2 weeks, 4 weeks, and 8 weeks
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