Study of Effectiveness of Telemedicine in Identifying Diabetic Retinopathy Cases

Diabetic Retinopathy Clinical Trial

— DRTM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085681
• Other study ID #: WT097685MA
• Status: Completed
• Phase: N/A
• First received: February 5, 2014
• Last updated: April 21, 2015
• Start date: May 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Aravind Eye Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

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.
• 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

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamil Nadu

Sponsors (2)

Lead Sponsor	Collaborator
Aravind Eye Care System	London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Barriers to compliance	Patients will be interviewed to identify the barriers to compliance following the referral	6 months	No
Other	Drivers of acceptance	Patients will be interviewed to identify the factors that encouraged them to visit the eye hospital following referral	6 months	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No