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

NCT07127276 | Not Yet Recruiting

• 1 other identifier: AG2508
• 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. 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)

Keywords

GERD; Gastroesophageal reflux disease; 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 General Medication Adherence Scale (GMAS)

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

Other: Mobile application GERDCare

Not using GERDCare

NO INTERVENTION

Not using the mobile application GERDCare

Interventions

Mobile application GERDCare OTHER

Features of GERDCare that support management of GERD

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

Location

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 10, 2025
• First Posted: August 17, 2025
• Study Start: August 15, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

VN (1)