GERD (Gastroesophageal Reflux Disease)
Conditions
Keywords
GERD, mobile apps, mobile applications, medication adherence
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.
Interventions
OTHERGERCCare mobile app
Using the smartphone application GERDCare (with detailed instructions provided during recruitment)
Sponsors
Institute of Gastroenterology and Hepatology, Vietnam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with good adherence at 4 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in GERD symptom severity | 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. |
| Proportion of patients with clinical improvement after 4 weeks | 4 weeks after recruitment | Symptom resolution evaluated clinically |
| Changes of patients' quality of life after 4 weeks | 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. |
Countries
Vietnam
Contacts
CONTACTBinh Phuc Nguyen, MD
CONTACTHang Viet Dao, MD, PhD
Outcome results
None listed