GERD (Gastroesophageal Reflux Disease)AppGERDNCT07127276
Evaluating Medication Adherence of Patients With Gastroesophageal Reflux Disease With Support of Smartphone Application GERDCare
A study testing Mobile application GERDCare in people with GERD (Gastroesophageal Reflux Disease), run by Institute of Gastroenterology and Hepatology, Vietnam at 1 site in Vietnam.
Trial summary
Adherence to GERD treatment, including medication, diet, and lifestyle, is essential for symptom control and complication prevention, yet adherence rates remain low due to various demographic and clinical factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD (Gastroesophageal Reflux Disease)
- What is being tested?
- Mobile application GERDCare
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Aug 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Presents with typical GERD symptoms (regurgitation, heartburn)
- Owns a smartphone and capable of using smartphone applications.
Who cannot join
- Acute GI conditions (upper GI bleeding, acute peptic ulcer…)
- GI malignancy (esophageal cancer, gastric cancer…)
- Severe chronic comorbidities (heart failure, liver failure, chronic kidney disease…)
- Pregnancy, alcohol abuse, mental health conditions impacting medication adherence or app usage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Institute of Gastroenterology and Hepatology
Hanoi, 100000
Binh Phuc Nguyen, MD, 0356665787, binhnguyen.fsh@gmail.com
About this study
Official title: Evaluating Medication Adherence of Patients With Gastroesophageal Reflux Disease With Support of the Smartphone Application GERDCare
Adherence to GERD treatment, including medication, diet, and lifestyle, is essential for symptom control and complication prevention, yet adherence rates remain low due to various demographic and clinical factors. Digital therapeutics, particularly mobile health applications, have shown promising potential in supporting chronic disease management and improving patient outcomes.
The GERDCare mobile application was developed with direct input from gastrointestinal experts. It is designed to enhance treatment adherence and patient engagement by offering features such as educational resources, symptom tracking, medication reminders, and direct communication between patients and physicians.
We are conducting a single-center, open-label, randomized controlled trial to evaluate the effectiveness of using GERDCare in improving patient adherence. Patients are followed up after four weeks of GERD treatment.
- Conditions
- GERD (Gastroesophageal Reflux Disease)
- Being tested
- Mobile application GERDCare
- Keywords
- GERD, Gastroesophageal reflux disease, mobile apps, mobile applications, medication adherence
- Medical subject headings
- Gastroesophageal Reflux, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application GERDCareOther
Features of GERDCare that support management of GERD
| Study group | Role | What they receive |
|---|---|---|
| Using GERDCare | Experimental | Using the mobile application GERDCare (detailed instructions provided at the time of the recruitment) Receives: Other: Mobile application GERDCare |
| Not using GERDCare | No intervention | Not using the mobile application GERDCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with good adherence at 4 weeks
Patients achieved a score of ≥27 points on the General Medication Adherence Scale (GMAS)
Measured: 4 weeks after recruitment
Secondary outcomes (3)
Changes in GERD symptom severity
GERD symptom severity evaluated by the GerdQ score
Measured: 4 weeks after recruitment
Proportion of patients with clinical improvement after 4 weeks
Symptom resolution evaluated clinically
Measured: 4 weeks after recruitment
Changes of patients' quality of life after 4 weeks
Patient's quality of life evaluated by the GERD-QoL score
Measured: 4 weeks after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERD (Gastroesophageal Reflux Disease)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Gastroenterology and Hepatology, Vietnam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127276
- Sponsor's protocol ID
- AG2508
- Acronym
- AppGERD
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Medication Adherence of Patients With Gastroesophageal Reflux Disease With Support of the Smartphone Application GERDCare
- ClinicalTrials.gov ID
- NCT07127276
- Acronym / sponsor ID
- AppGERD / AG2508
- Conditions
- GERD (Gastroesophageal Reflux Disease)
- Keywords
- GERD, Gastroesophageal reflux disease, mobile apps, mobile applications, medication adherence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Institute of Gastroenterology and Hepatology, VietnamUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 17 Aug 2025 (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.
Adherence to GERD treatment, including medication, diet, and lifestyle, is essential for symptom control and complication prevention, yet adherence rates remain low due to various demographic and clinical factors. Digital therapeutics, particularly mobile health applications, have shown promising potential in supporting chronic disease management and improving patient outcomes.
The GERDCare mobile application was developed with direct input from gastrointestinal experts. It is designed to enhance treatment adherence and patient engagement by offering features such as educational resources, symptom tracking, medication reminders, and direct communication between patients and physicians.
We are conducting a single-center, open-label, randomized controlled trial to evaluate the effectiveness of using GERDCare in improving patient adherence. Patients are followed up after four weeks of GERD treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using GERDCare | Experimental | Other: Mobile application GERDCareUsing the mobile application GERDCare (detailed instructions provided at the time of the recruitment) |
| Not using GERDCare | No intervention | –Not using the mobile application GERDCare |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years old
- Presents with typical GERD symptoms (regurgitation, heartburn)
- Owns a smartphone and capable of using smartphone applications.
Key exclusion criteria (4 listed)
- Acute GI conditions (upper GI bleeding, acute peptic ulcer…)
- GI malignancy (esophageal cancer, gastric cancer…)
- Severe chronic comorbidities (heart failure, liver failure, chronic kidney disease…)
- Pregnancy, alcohol abuse, mental health conditions impacting medication adherence or app usage
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 |
|---|---|---|
| Mobile application GERDCareFeatures of GERDCare that support management of GERD | Other | Using GERDCare |
Primary outcome
Proportion of patients with good adherence at 4 weeks
Time frame: 4 weeks after recruitment
Patients achieved a score of ≥27 points on the General Medication Adherence Scale (GMAS)
3 secondary outcomes
Changes in GERD symptom severity
Time frame: 4 weeks after recruitment
Proportion of patients with clinical improvement after 4 weeks
Time frame: 4 weeks after recruitment
Changes of patients' quality of life after 4 weeks
Time frame: 4 weeks after recruitment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application GERDCare in people with GERD (Gastroesophageal Reflux Disease), run by Institute of Gastroenterology and Hepatology, Vietnam at 1 site in Vietnam.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Aug 2025. 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Binh Phuc Nguyen, MD (+84356665787, binhnguyen.fsh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with good adherence at 4 weeks (time frame: 4 weeks after recruitment). 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 17 Aug 2025.