Study of Effectiveness of Telemedicine in Identifying Diabetic Retinopathy Cases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

801 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-03-31

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

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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.

Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Tele-medicine

Tele-medicine aided retinal imaging and referral to eye hospital

Group Type EXPERIMENTAL

Tele-medicine

Intervention Type OTHER

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.

Conventional Referral

Patients will be counselled on the importance of eye examination and will be referred to the eye hospital in the conventional manner.

Group Type OTHER

Conventional referral

Intervention Type OTHER

All eligible patients in the conventional arm will be counselled on the importance of eye screening and will be referred to the eye hospital

Interventions

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Tele-medicine

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.

Intervention Type OTHER

Conventional referral

All eligible patients in the conventional arm will be counselled on the importance of eye screening and will be referred to the eye hospital

Intervention Type OTHER

Other Intervention Names

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Tele-medicine aided retinal imaging

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No