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临床试验/NCT04544553
NCT04544553已完成不适用

To Understand the Barriers and Facilitators of Diabetic Retinopathy Screening & Follow-up: An Exploratory Study From India and Thailand

Lions Club International Foundation2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
Attendance rates in patients with diabetic macular edema receiving short messaging services

研究概览

简要总结

Brief Summary: Diabetic retinopathy (DR) is a leading cause of visual impairment and has major public health implications globally and especially in countries such as India where the prevalence of diabetes is high. With timely screening and intervention, the disease progression to blindness can be prevented but several barriers exist to the provision of care. The long term aim is to identify the barriers to DR screening and to plan potential interventional strategies. From the qualitative study, the reasons such as lack of awareness or knowledge, distance to travel, lack of reminder system were identified as a reason for poor follow-up. This lead to the development of interventional strategies.

This was a randomized, investigator-masked clinical trial that was conducted in a tertiary eye care centre in South India. Consecutive patients with diabetes who were residents in Chennai and its vicinity of approximately 100 km radius and who were undergoing repeated intravitreal injections for DME were recruited into the trial. The aim of the study is to investigate the effect of SMS informational reminders among patients with Diabetic macular edema for the follow-up. They study consists of 2 groups, SMS reminder group receives the reminders 1 week and 2 days prior to the scheduled appointments with the concerned doctor on a particular date and time, whereas other group does not receive any reminders for the appointment schedule. After the follow-up, the patients will be screened for the attendance at the review visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with > 40 years of age
  • Diagnosed as centre involving Diabetic macular edema (DME)
  • Patients who received intravitreal injections for DME
  • Ability to give informed consent

排除标准

  • Patients from outside the area of residence who stayed more than 100 km from the hospital
  • Patients with ocular co-morbidities other than DME

结局指标

主要结局

Attendance rates in patients with diabetic macular edema receiving short messaging services

时间窗: 7 months

To investigate the effect of SMS informational reminders on adherence with scheduled eye examinations among patients with center involving DME receiving intravitreal injections in a tertiary eye care institute in South India.

次要结局

未报告次要终点

研究者

发起方
Lions Club International Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rajiv Raman

Senior Consultant (Ophthalmologist)

Sankara Nethralaya

研究点 (2)

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