Mobile Application for Gastroesophageal Reflux Disease

NCT07744815 | Completed

• 1 other identifier: YGHIRB-20250812B
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Esophagitis

Keywords

GERD; Mobile Application; Sleep Quality; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 2 weeks, 4 weeks, and 8 weeks

Secondary Outcomes (2)

• GERD-Related Quality of Life

  Baseline, 2 weeks, 4 weeks, and 8 weeks

• Sleep Quality

  Baseline, 2 weeks, 4 weeks, and 8 weeks

Study Arms (2)

Mobile Application + Standard Education

EXPERIMENTAL

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.

Behavioral: Study Mobile Application; Behavioral: Standard Education

Standard Education Alone

ACTIVE COMPARATOR

Participants receive standard education for gastroesophageal reflux disease without access to the study mobile application.

Behavioral: Standard Education

Interventions

Study Mobile Application BEHAVIORAL

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.

Mobile Application + Standard Education

Standard Education BEHAVIORAL

Participants receive standard education for gastroesophageal reflux disease.

Mobile Application + Standard Education; Standard Education Alone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fooyin University: lead

Study Sites (1)

Yuan's General Hospital

Kaohsiung City, 80249, Taiwan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Yi-Hsuan Liu, Nurse Practitioner

  Fooyin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Practitioner

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start: September 15, 2025
• Primary Completion: February 16, 2026
• Study Completion: February 16, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)