Evaluating Medication Adherence of Patients With Gastroesophageal Reflux Disease With Support of Smartphone Application GERDCare

NCT ID: NCT07127276

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-15

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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GERD (Gastroesophageal Reflux Disease)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Using GERDCare

Using the mobile application GERDCare (detailed instructions provided at the time of the recruitment)

Group Type EXPERIMENTAL

Mobile application GERDCare

Intervention Type OTHER

Features of GERDCare that support management of GERD

Not using GERDCare

Not using the mobile application GERDCare

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile application GERDCare

Features of GERDCare that support management of GERD

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥18 years old
* Presents with typical GERD symptoms (regurgitation, heartburn)
* Owns a smartphone and capable of using smartphone applications.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Gastroenterology and Hepatology, Vietnam

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Gastroenterology and Hepatology

Hanoi, , Vietnam

Site Status

Countries

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Vietnam

Central Contacts

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Binh Phuc Nguyen, MD

Role: CONTACT

+84356665787

Hang Viet Dao, MD, PhD

Role: CONTACT

+84987988075

Facility Contacts

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Binh Phuc Nguyen, MD

Role: primary

0356665787

Other Identifiers

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AG2508

Identifier Type: -

Identifier Source: org_study_id

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