Study of Effectiveness of Telemedicine in Identifying Diabetic Retinopathy Cases (DRTM)

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

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Other: Tele-medicine; Other: Conventional referral

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 801
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Tamil Nadu
    • Madurai, Tamil Nadu, India, 625020
      • Aravind Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-medicine; Tele-medicine aided retinal imaging and referral to eye hospital	Other: 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.; Other Names: Tele-medicine aided retinal imaging
Other: Conventional Referral; 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; All eligible patients in the conventional arm will be counselled on the importance of eye screening and will be referred to the eye hospital

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers to compliance	Patients will be interviewed to identify the barriers to compliance following the referral	6 months
Drivers of acceptance	Patients will be interviewed to identify the factors that encouraged them to visit the eye hospital following referral	6 months

Collaborators and Investigators

• Sponsor: Aravind Eye Care System
• Collaborators: London School of Hygiene and Tropical Medicine
• Investigators: Principal Investigator: Sanil Joseph, MHA, MSc, Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai, India; Study Chair: Ramasamy Kim, DO, DNB, Aravind Eye Hospital, Madruai, India; Study Chair: Thulasiraj Ravilla, MBA, Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai; Study Chair: Astrid Fletcher, MSc, PhD, London School of Hygiene and Tropical Medicine

Publications and helpful links

General Publications

• Joseph S, Kim R, Ravindran RD, Fletcher AE, Ravilla TD. Effectiveness of Teleretinal Imaging-Based Hospital Referral Compared With Universal Referral in Identifying Diabetic Retinopathy: A Cluster Randomized Clinical Trial. JAMA Ophthalmol. 2019 Jul 1;137(7):786-792. doi: 10.1001/jamaophthalmol.2019.1070.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: February 5, 2014
• First Submitted That Met QC Criteria: March 8, 2014
• First Posted (Estimate): March 13, 2014

Study Record Updates

• Last Update Posted (Estimate): April 22, 2015
• Last Update Submitted That Met QC Criteria: April 21, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Screening; Diabetic Retinopathy; Retinal Imaging; Tele-medicine; Remote diagnosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: WT097685MA