Smart Phone App Based Measurement of Short-Term Adherence to Anti Glaucoma Medications: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- To compare the adherence between the group which receives free drug sample and the group which buys the medications on there own for 60 days as measured by the smart phone app (as measured by the EyePhone© App)
研究概览
简要总结
This prospective, randomized, crossover study aims to assess the short-term effect of providing a free sample of ocular hypotensive medication on the adherence patterns of glaucoma patients, in terms of:
-
daily use of drops
-
obtaining medication refills in a timely manner
We are also aiming to assess the applicability of the EyePhone© App, which is a free non-commercial reminder application, available for the Åndroid mobile operating system, designed specifically for the needs of glaucoma patients and allows self-monitoring of adherence. Over one month of follow-up, use of the app has been shown to significantly improve adherence to topical IOP-lowering medications among glaucoma patients in Israel.
We hypothesize that:
1) Patients who are given an initial free supply of ocular hypotensive medications will have better medication adherence in the short term (when the free supply is no longer available) than patients who need to purchase the medications on their own.
2) Patients who are given a free initial supply of ocular hypotensive medication will have better adherence and renew IOP lowering prescriptions in a more timely fashion than patients who do not receive free supply.
3) Patients who are given an initial free supply of ocular hypotensive medication will have overall better IOP control than patients who do not receive any samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Day(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients aged 18 years or more who are willing to participate 2.Newly diagnosed patients with open angle glaucoma (including primary open angle glaucoma, juvenile open angle glaucoma, pigmentary dispersion glaucoma, pseudoexfoliation glaucoma and normal tension glaucoma) 3.Initiated treatment with a once-daily dose of timolol or latanoprost alone, in both eyes 4.Readily access an Ã…ndroid mobile operating system smartphone and internet service by either the patient or the patient’s caregiver 5.Have the ability to successfully self-administer a drop of IOP lowering medication or patients with a caregiver that can administer the drops for them.
排除标准
- •1.Patients who are unable to obtain drops locally 2.Patients under monocular ocular hypotensive treatment 3.Patients with secondary glaucomas (all except Pigmentary and Pseudoexfoliation glaucoma) 4.Patients that require surgical intervention for glaucoma or other ocular disease 5.Patients with other ocular co-morbidities, which may need intervention for the same.
结局指标
主要结局
To compare the adherence between the group which receives free drug sample and the group which buys the medications on there own for 60 days as measured by the smart phone app (as measured by the EyePhone© App)
时间窗: Adherence to AGM will be measured based on response to the phone app and questionnaire based survey at 2 months after which cross-over will be done between the groups and at 4th month the same will be repeated
次要结局
- -To evaluate various measures of adherence & identify barriers for good adherence (dosing errors, coverage, inter-dose interval, percent of doses taken)(-Correlation between self-reported adherence via questionnaire vs. recorded live responses over time using the EyePhone app)
研究者
Usha Tejaswini S
Aravind Eye Hospital, Pondicherry