BACKGROUND Glaucoma treatment requires patients to follow daily, often times complex, eye drop regimens, but adherence is poor for many patients, putting them at risk for irreversible vision loss. A comprehensive approach is needed to address the challenges in the self-management of glaucoma. The purpose of this study is to improve glaucoma medication adherence in Veterans with medically treated glaucoma using an education-based intervention. METHODS/DESIGN This study is a single-site randomized controlled trial enrolling 200 Veterans and their companions, if companions are involved in their care. It has two arms: an intervention group and a control group. Participants in the intervention group receive an educational session with a non-physician interventionist and are provided with an AdhereTech smart bottle with the reminder functions activated. The control group is designed as an attention control such that they have a session on general eye health and are provided with a smart bottle but without the reminder functions activated. The primary outcome is the proportion of prescribed doses taken on schedule over 6 months following randomization according to the smart bottle. Secondary outcomes include intensification of glaucoma treatment, cost of intervention delivery, and cost-effectiveness of the intervention over 12 months. DISCUSSION The education-based intervention that we are testing is comprehensive in scope, to encompass a variety of barriers to adherence that glaucoma patients encounter, but personalized to address issues facing individual patients. Particular attention was given to feasibility in the real-world setting, as the high throughput of patients and lack of reimbursement for educational encounters in ophthalmology would limit implementation of a resource-intensive intervention.

中文翻译：

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基于教育的干预措施的随机对照试验，以提高药物依从性：设计考虑青光眼药物依从性以改善护理研究

背景技术青光眼治疗需要患者每天遵循通常复杂的滴眼液方案，但许多患者的依从性很差，使他们面临不可逆视力丧失的风险。需要一种综合方法来应对青光眼自我管理方面的挑战。本研究的目的是通过基于教育的干预措施，提高接受药物治疗的青光眼退伍军人的青光眼药物依从性。方法/设计 本研究是一项单点随机对照试验，招募了 200 名退伍军人及其同伴，如果同伴参与了他们的护理。它有两个分支：一个干预组和一个对照组。干预组的参与者接受了与非医师干预人员的教育课程，并获得了一个具有激活提醒功能的 AdhereTech 智能瓶。对照组被设计成一个注意力控制，这样他们就可以进行一般眼睛健康的会议，并获得一个智能瓶子，但没有激活提醒功能。主要结果是根据智能瓶随机化后 6 个月内按计划服用处方剂量的比例。次要结果包括青光眼治疗的强化、干预实施的成本以及 12 个月内干预的成本效益。讨论 我们正在测试的基于教育的干预措施范围广泛，包括青光眼患者遇到的各种依从性障碍，但个性化解决个别患者面临的问题。特别关注现实环境中的可行性，