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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Digital Reminder Intervention
  A behavioral adherence support intervention consisting of daily interactive SMS/WhatsApp reminders for eye-drop use and weekly educational reinforcement messages over 3 months.

Первичные конечные точки

• Change in Medication Adherence [Срок оценки: Baseline and Month 3]

Вторичные конечные точки (1)

• Change in Intraocular Pressure (IOP) [Срок оценки: Baseline and Month 3]

Критерии участия

Критерии включения

Adults aged 18 to 75 years. Diagnosis of primary open-angle glaucoma (POAG) in at least one eye. Currently treated with at least one topical antiglaucoma medication. Able to read and understand study procedures and provide written informed consent.

Has regular access to a mobile phone capable of receiving SMS or WhatsApp messages.

Willing to comply with follow-up visits and study procedures for 3 month

Критерии исключения

Secondary glaucoma (e.g., neovascular, uveitic, steroid-induced) or angle-closure glaucoma.

Ocular surgery or laser procedure within the previous 3 months, or planned ocular surgery during study follow-up.

Advanced ocular comorbidity likely to affect IOP assessment or adherence evaluation (e.g., severe corneal disease, active ocular infection/inflammation).

Cognitive impairment, severe psychiatric disease, or communication barriers that prevent reliable participation.

Inability to use or access mobile messaging tools required for the intervention.

Participation in another interventional clinical study that may interfere with outcomes

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07480577 · 2026/1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗