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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 主要终点
- Change in Medication Adherence
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label behavioral intervention trial. Participants and treating clinicians are aware of assignment due to the nature of the mobile reminder intervention.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Digital Reminder Intervention
Participants receive a personalized mobile adherence program in addition to standard glaucoma care, including daily interactive SMS/WhatsApp medication reminders and weekly brief educational messages for 3 months.
干预措施: Digital Reminder Intervention (Behavioral)
Standard Care
Participants receive routine outpatient glaucoma follow-up and prescribed topical antiglaucoma treatment without digital reminders.
结局指标
主要结局
Change in Medication Adherence
时间窗: Baseline and Month 3
Difference in Morisky Medication Adherence Scale-8 (MMAS-8) total score from baseline to month 3, and between-group comparison of mean change. Higher scores indicate better adherence.
次要结局
- Change in Intraocular Pressure (IOP)(Baseline and Month 3)
研究者
Ali Altan Ertan Boz
Yenikent State Hospital, Head of Ophthalmology
Sakarya Yenikent State Hospital