DRTM: Study of Effectiveness of Telemedicine in Identifying Diabetic Retinopathy Cases

Sponsor

Aravind Eye Care System (Other)

Overall Status

Completed

CT.gov ID

NCT02085681

Collaborator

London School of Hygiene and Tropical Medicine (Other)

801

Enrollment

Location

Arms

Duration (Months)

80.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Other: Tele-medicine Other: Conventional referral	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

801 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Proportion of patients with confirmed Diabetic Retinopathy (DR) diagnosed at the eye hospital [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.

Secondary Outcome Measures

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

Other Outcome Measures

Barriers to compliance [6 months]
Patients will be interviewed to identify the barriers to compliance following the referral
Drivers of acceptance [6 months]
Patients will be interviewed to identify the factors that encouraged them to visit the eye hospital following referral

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aravind Eye Hospital	Madurai	Tamil Nadu	India	625020

Sponsors and Collaborators

Aravind Eye Care System
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