Gastroesophageal Reflux Esophagitis
Conditions
Keywords
GERD, Mobile Application, Sleep Quality, Quality of Life
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStudy Mobile Application
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.
BEHAVIORALStandard Education
Participants receive standard education for gastroesophageal reflux disease.
Sponsors
Fooyin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomly assigned to one of two parallel groups. The intervention group receives a mobile application in addition to standard education, while the control group receives standard education alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GERD Symptom severity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GERD-Related Quality of Life | Baseline, 2 weeks, 4 weeks, and 8 weeks | 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. |
| Sleep Quality | Baseline, 2 weeks, 4 weeks, and 8 weeks | 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). |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORYi-Hsuan Liu, Nurse Practitioner
Fooyin University
Outcome results
None listed