Study of Effectiveness of Telemedicine in Identifying Diabetic Retinopathy Cases (DRTM)
2015年4月21日 更新者：Sanil Joseph、Aravind Eye Care System
Effectiveness of Tele-medicine in Identifying Diabetic Retinopathy Cases Attending Diabetologists' Clinics Compared to the Conventional Referral System
The aim of this study is to compare the effectiveness of identifying diabetic retinopathy using tele-medicine based Digital Retinal Imaging in Diabetes Clinics with that of the conventional referral system.
Hypothesis: Tele-medicine based digital retinal imaging involving a diabetes centre will identify proportionately more diabetic patients with DR and lead to higher acceptance rate with subsequent ophthalmic referral and management
研究概览
详细说明
The design is a cluster randomized trial of tele-medicine versus usual care in diabetic patients.
The primary outcome of the study is the proportion of patients with confirmed DR at Aravind Eye Hospital (AEH).
DR will be graded using the International Clinical Diabetic Retinopathy Disease Severity Scale.
A sample size of 616 patients in both arms is required to detect a risk ratio of 1.8 or above at 90% power, 1% alpha and a design effect of 2. Eight clinics will be recruited and equally randomized to tele-medicine or usual care stratified by distance from AEH. Inclusion criteria include a confirmed diagnosis of diabetes, age over 50, no retinal exam in the previous year.
In the tele-medicine arm patients will be offered fundus imaging and patients diagnosed with DR or probable DR will be counselled to visit AEH to confirm DR.
In the usual care arm, the eligible patients will be counselled and referred to undergo an eye examination at AEH.
In both the arms the counselling and the awareness creation materials will be standardized.
Fundus imaging will be offered at the end of the study to those who refuse initially and all those in the usual arm who did not attend AEH.
研究类型
介入性
注册 (实际的)
801
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Tamil Nadu
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Madurai、Tamil Nadu、印度、625020
- Aravind Eye Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diabetic patients (as per ICD-9 code 250) in the age group of ≥50 years
Exclusion Criteria:
- Patients <50 years of age
- Already enrolled as study patients at the diabetes centre
- Patients screened for DR in free camps organized by the diabetes centre
- Diabetic patients who underwent retinal examination in the previous year prior to this intervention
- Patients with disability (physical or mental) who have difficulty in travelling to the eye hospital
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Tele-medicine
Tele-medicine aided retinal imaging and referral to eye hospital
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Patients at the diabetes clinics will be subjected to non-mydriatic retinal imaging and the images will be transferred to the eye hospital via internet using a specified software - Aravind Diabetic Retinopathy Evaluation Software (ADRES) that enables a retinal specialist to read and grad the image and send the feedback immediately to the diabetes clinic.
Based on the presence or absence of DR the patients will be referred to the eye hospital for detailed retinal examination.
其他名称：
|
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其他：Conventional Referral
Patients will be counselled on the importance of eye examination and will be referred to the eye hospital in the conventional manner.
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All eligible patients in the conventional arm will be counselled on the importance of eye screening and will be referred to the eye hospital
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of patients with confirmed Diabetic Retinopathy (DR) diagnosed at the eye hospital
大体时间：6 months
|
Out of the patients referred from the diabetes clinics to the eye hospital, the number of patients with confirmed DR will be measured.
This proportion will be compared between the two arms.
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The severity of diabetic retinopathy (DR)
大体时间：6 months
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Among patients confirmed with DR, the severity of the disease will be measured using standard classification (Diabetic Retinopathy Disease Severity Scale) approved by the American Academy of Ophthalmology
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6 months
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The acceptance rate for referral in each arm
大体时间：6 months
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Out of the patients referred from the diabetes clinic, the number of patients actually reported to the eye hospital will be measured.
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6 months
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Proportion of patients eligible for referral who had DR and who did not attend
大体时间：6 months
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Patients who are referred by not attended to the eye hospital will be followed up and examined to find out what proportion of them actually as DR
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6 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Barriers to compliance
大体时间：6 months
|
Patients will be interviewed to identify the barriers to compliance following the referral
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6 months
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Drivers of acceptance
大体时间：6 months
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Patients will be interviewed to identify the factors that encouraged them to visit the eye hospital following referral
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6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Sanil Joseph, MHA, MSc、Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai, India
- 学习椅：Ramasamy Kim, DO, DNB、Aravind Eye Hospital, Madruai, India
- 学习椅：Thulasiraj Ravilla, MBA、Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai
- 学习椅：Astrid Fletcher, MSc, PhD、London School of Hygiene and Tropical Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年5月1日
初级完成 (实际的)
2015年1月1日
研究完成 (实际的)
2015年3月1日
研究注册日期
首次提交
2014年2月5日
首先提交符合 QC 标准的
2014年3月8日
首次发布 (估计)
2014年3月13日
研究记录更新
最后更新发布 (估计)
2015年4月22日
上次提交的符合 QC 标准的更新
2015年4月21日
最后验证
2015年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.