Study of Effectiveness of Telemedicine in Identifying Diabetic Retinopathy Cases (DRTM)
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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|
- Proportion of patients with confirmed Diabetic Retinopathy (DR) diagnosed at the eye hospital [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- The severity of diabetic retinopathy (DR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]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
- Barriers to compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]Patients will be interviewed to identify the barriers to compliance following the referral
- Drivers of acceptance [ Time Frame: 6 months ] [ Designated as safety issue: No ]Patients will be interviewed to identify the factors that encouraged them to visit the eye hospital following referral
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Tele-medicine aided retinal imaging and referral to eye hospital
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 Name: Tele-medicine aided retinal imaging
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02085681
|Contact: Sanil Joseph, MHA, MSc||+914524356500 ext email@example.com|
|Contact: Thulasiraj Ravilla, MBA||+914524356500 ext firstname.lastname@example.org|
|Aravind Eye Hospital||Recruiting|
|Madurai, Tamil Nadu, India, 625020|
|Contact: Sanil Joseph, MHA +914524356500 ext 522 email@example.com|
|Contact: Thulasiraj Ravilla, MBA +914524356500 ext 526 firstname.lastname@example.org|
|Principal Investigator: Sanil Joseph, MHA, MSc|
|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|