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Not Yet RecruitingNCT07480577

Personalized Mobile Reminders for Medication Adherence and Intraocular Pressure Control in Primary Open-Angle Glaucoma

Effectiveness of a Personalized Mobile Reminder System on Medication Adherence and Intraocular Pressure Control in Primary Open-Angle Glaucoma: A Prospective, Parallel-Group, Randomized Controlled Trial

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
84 (estimated)
Sponsor
Sakarya Yenikent State Hospital · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This study evaluates whether a personalized mobile reminder program improves treatment adherence and clinical outcomes in adults with primary open-angle glaucoma (POAG) using topical antiglaucoma eye drops. Poor adherence to long-term eye-drop therapy is common in glaucoma care and may contribute to inadequate intraocular pressure (IOP) control and disease progression. Participants are randomized to either (1) a digital adherence intervention or (2) standard outpatient follow-up. The intervention consists of daily interactive SMS/WhatsApp medication reminders plus weekly brief educational messages for 3 months. The primary outcome is change in medication adherence measured by the Morisky Medication Adherence Scale-8 (MMAS-8) at month 3. Secondary outcomes include change in IOP, eye-drop instillation technique, and treatment satisfaction. Exploratory analyses assess the relationship between adherence level and OCT-based retinal nerve fiber layer (RNFL) progression metrics. The goal is to determine whether a low-cost, scalable mobile strategy can improve short-term glaucoma management in routine practice.

Detailed description

Primary open-angle glaucoma (POAG) is a chronic optic neuropathy in which sustained reduction of intraocular pressure (IOP) remains the main modifiable treatment target. In real-world care, nonadherence and incorrect eye-drop technique are frequent and can reduce treatment effectiveness. Digital reminder systems may improve adherence behavior; however, prospective randomized evidence in routine glaucoma clinics is still limited. This is a single-center, prospective, parallel-group, randomized controlled trial designed to assess the effectiveness of a personalized mobile reminder intervention in adults with POAG receiving topical antiglaucoma treatment. A total of 84 participants are allocated 1:1 to intervention or standard care. Intervention arm participants receive: Daily interactive medication reminders (SMS/WhatsApp) Weekly short educational messages focused on glaucoma, medication use, and practical adherence support Control arm participants continue standard outpatient follow-up without the digital reminder package. Follow-up duration is 3 months. The primary endpoint is change in MMAS-8 score from baseline to month 3. Secondary endpoints are change in IOP, change in correct eye-drop instillation technique, and treatment satisfaction. Exploratory analyses evaluate whether higher adherence is associated with more favorable OCT-derived RNFL slope patterns (global and quadrant-based estimates from retrospective imaging data). Planned statistical comparisons include between-group analyses using independent-samples t tests and adjusted analyses using ANCOVA. Analyses are performed on a complete-case basis for the 3-month follow-up period. Because of single-center design, modest sample size, and short follow-up, structural OCT findings are considered exploratory and hypothesis-generating.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDigital Reminder InterventionA behavioral adherence support intervention consisting of daily interactive SMS/WhatsApp reminders for eye-drop use and weekly educational reinforcement messages over 3 months.

Timeline

Start date
2026-04-01
Primary completion
2026-07-01
Completion
2026-08-01
First posted
2026-03-18
Last updated
2026-03-18

Source: ClinicalTrials.gov record NCT07480577. Inclusion in this directory is not an endorsement.