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NCT Number: NCT07125521

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.

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.

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Key information

Conditions

GERD (Gastroesophageal Reflux Disease) Behavior Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Gastroenterology and Hepatology

Hanoi, 100000, Vietnam

Location status: Recruiting

Location contact

Binh Phuc Nguyen, MD

CONTACT

[email protected]

+84356665787

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GERCCare mobile app

Other

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

Primary outcomes

  1. Proportion of patients with good adherence at 4 weeks

    Time frame: 4 weeks after recruitment

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

Secondary outcomes

  1. Changes in GERD symptom severity

    Time frame: 4 weeks after recruitment

    GERD symptom severity evaluated by the Gastroesophageal Reflux Disease Questionnaire (GerdQ) Score. The score has a minimum value of 0 and a maximum value of 18. High scores present more severe GERD symptoms. Value ≥ 8 means high probability of GERD.

  2. Proportion of patients with clinical improvement after 4 weeks

    Time frame: 4 weeks after recruitment

    Symptom resolution evaluated clinically

  3. Changes of patients' quality of life after 4 weeks

    Time frame: 4 weeks after recruitment

    Patient's quality of life evaluated by the GERD Quality of Life (GERD-QoL) score. It is an 18-item questionnaire grouped into four subscales (Daily activity, Treatment effect, Diet, and Psychological well-being). The total score was converted to a scale of 0-100, in which 100 means high influence on quality of life caused by GERD symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Binh Phuc Nguyen, MD

CONTACT

[email protected]

+84356665787

Hang Viet Dao, MD, PhD

CONTACT

[email protected]

+84987988075

Sponsors and collaborators

Lead sponsor

Institute of Gastroenterology and Hepatology, Vietnam

Other

Registry information

Acronym: AppGERD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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