Gastroesophageal Reflux EsophagitisNCT07744815
Mobile Application for Gastroesophageal Reflux Disease
A study testing Study Mobile Application and Standard Education in people with Gastroesophageal Reflux Esophagitis, run by Fooyin University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastroesophageal Reflux Esophagitis
- What is being tested?
- Study Mobile Application and Standard Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Sep 2025to 16 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Neurological disorders affecting participation.
- Malignancy other than early-stage cancer.
- Hiatal hernia larger than 2 cm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Mobile Application in Reducing Symptom Recurrence and Improving Quality of Life and Sleep Quality in Patients With Gastroesophageal Reflux Disease
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux Esophagitis
- Being tested
- Study Mobile Application, Standard Education
- Keywords
- GERD, Mobile Application, Sleep Quality, Quality of Life
- Medical subject headings
- Gastroesophageal Reflux, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Mobile ApplicationBehavioural
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.
Standard EducationBehavioural
Participants receive standard education for gastroesophageal reflux disease.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 weeks, 4 weeks, and 8 weeks
Secondary outcomes (2)
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.
Measured: 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).
Measured: Baseline, 2 weeks, 4 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start15 Sep 2025
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fooyin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Hsuan, Liu, Fooyin University
- Investigators
- Yi-Hsuan Liu, Nurse Practitioner, Principal investigator, Fooyin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744815
- Sponsor's protocol ID
- YGHIRB-20250812B
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because data sharing was not included in the study protocol or informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mobile Application in Reducing Symptom Recurrence and Improving Quality of Life and Sleep Quality in Patients With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT07744815
- Acronym / sponsor ID
- YGHIRB-20250812B
- Conditions
- Gastroesophageal Reflux Esophagitis
- Keywords
- GERD, Mobile Application, Sleep Quality, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fooyin UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mobile Application + Standard Education | Experimental | Behavioral: Study Mobile Application, Behavioral: Standard EducationParticipants 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. |
| Standard Education Alone | Active comparator | Behavioral: Standard EducationParticipants receive standard education for gastroesophageal reflux disease without access to the study mobile application. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study Mobile ApplicationParticipants receive a study mobile application providing gastroesophageal reflux disease education, lifestyle modification guidance, dietary recommendations, diaphragmatic breathing exercises, and reminder messages for 4 weeks. | Behavioural | Mobile Application + Standard Education |
| Standard EducationParticipants receive standard education for gastroesophageal reflux disease. | Behavioural | Mobile Application + Standard Education, Standard Education Alone |
Primary outcome
GERD Symptom severity
Time frame: 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.
2 secondary outcomes
GERD-Related Quality of Life
Time frame: Baseline, 2 weeks, 4 weeks, and 8 weeks
Sleep Quality
Time frame: Baseline, 2 weeks, 4 weeks, and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because data sharing was not included in the study protocol or informed consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Hsuan Liu, Nurse Practitioner principal investigator
Fooyin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Mobile Application and Standard Education in people with Gastroesophageal Reflux Esophagitis, run by Fooyin University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GERD Symptom severity (time frame: Baseline, 2 weeks, 4 weeks, and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.