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

NCT07125521 | Recruiting

• 1 other identifier: AG2410
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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. 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. The investigators 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)

Keywords

GERD; mobile apps; mobile applications; medication adherence

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with good adherence at 4 weeks

  Patients achieved a score of ≥27 points on the Vietnamese Version of the General Medication Adherence Scale (GMAS). Higher scores mean better adherence.

  4 weeks after recruitment

Secondary Outcomes (3)

• Changes in GERD symptom severity

  4 weeks after recruitment

• Proportion of patients with clinical improvement after 4 weeks

  4 weeks after recruitment

• Changes of patients' quality of life after 4 weeks

  4 weeks after recruitment

Study Arms (2)

Using GERDCare

EXPERIMENTAL

Using the mobile phone application GERDCare (with detailed instructions provided during recruitment)

Other: GERCCare mobile app

Not using GERDCare

NO INTERVENTION

Not using the smartphone application GERDCare

Interventions

GERCCare mobile app OTHER

Using the smartphone application GERDCare (with detailed instructions provided during recruitment)

Using GERDCare

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Gastroenterology and Hepatology, Vietnam: lead

Study Sites (1)

Institute of Gastroenterology and Hepatology

Hanoi, 100000, Vietnam

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux; Medication Adherence

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Binh Phuc Nguyen, MD

CONTACT

+84356665787; binhnguyen.fsh@gmail.com

Hang Viet Dao, MD, PhD

CONTACT

+84987988075; hangdao.fsh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 15, 2025
• Study Start: August 18, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

VN (1)