About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
Presents with typical GERD symptoms (regurgitation, heartburn)
Owns a smartphone and capable of using smartphone applications.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Mobile application GERDCare
Other interventionFeatures of GERDCare that support management of GERD
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients with good adherence at 4 weeks
Patients achieved a score of ≥27 points on the General Medication Adherence Scale (GMAS)
Secondary outcomes
Changes in GERD symptom severity
GERD symptom severity evaluated by the GerdQ score
Proportion of patients with clinical improvement after 4 weeks
Symptom resolution evaluated clinically
Changes of patients' quality of life after 4 weeks
Patient's quality of life evaluated by the GERD-QoL score
Sponsors and contacts
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