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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Gastroenterology and Hepatology, Vietnam

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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Design model

Parallel

Treatments tested in this trial

  • GERCCare mobile app

    Other intervention

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

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: Using GERDCareExperimental treatment 1 intervention
Group B: Not using GERDCareNo intervention 0 interventions

Trial outcomes

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.

Time frame
4 weeks after recruitment

Secondary outcomes

1

Changes in GERD symptom severity

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.

Time frame
4 weeks after recruitment
2

Proportion of patients with clinical improvement after 4 weeks

Symptom resolution evaluated clinically

Time frame
4 weeks after recruitment
3

Changes of patients' quality of life after 4 weeks

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.

Time frame
4 weeks after recruitment

Other outcomes

Sponsors and contacts

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