Study of Effectiveness of Telemedicine in Identifying Diabetic Retinopathy Cases

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Effectiveness of Tele-medicine in Identifying Diabetic Retinopathy Cases Attending Diabetologists' Clinics Compared to the Conventional Referral System

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Other: Tele-medicine
* Other: Conventional referral


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-medicine<br>Tele-medicine aided retinal imaging and referral to eye hospital | Other: Tele-medicine<br>* 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.<br>* Other names: Tele-medicine aided retinal imaging;|
| Other: Conventional Referral<br>Patients will be counselled on the importance of eye examination and will be referred to the eye hospital in the conventional manner. | Other: Conventional referral<br>* All eligible patients in the conventional arm will be counselled on the importance of eye screening and will be referred to the eye hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with confirmed Diabetic Retinopathy (DR) diagnosed at the eye hospital | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of diabetic retinopathy (DR) | 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 | 6 months | 
| The acceptance rate for referral in each arm | Out of the patients referred from the diabetes clinic, the number of patients actually reported to the eye hospital will be measured. | 6 months | 
| Proportion of patients eligible for referral who had DR and who did not attend | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Retinopathy, Screening, Tele-medicine, Retinal Imaging, Remote diagnosis