Clinical trial NCT02085681: Study of Effectiveness of Telemedicine in Identifying Diabetic Retinopathy Cases
Official title: Effectiveness of Tele-medicine in Identifying Diabetic Retinopathy Cases Attending Diabetologists' Clinics Compared to the Conventional Referral System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Keywords: Diabetic Retinopathy
Screening
Tele-medicine
Retinal Imaging
Remote diagnosis
Lead sponsor: Aravind Eye Care System
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
First posted: 2014-03-13
Enrollment: 801
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with confirmed Diabetic Retinopathy (DR) diagnosed at the eye hospital
timeFrame: 6 months
Secondary outcomes:
measure: The severity of diabetic retinopathy (DR)
timeFrame: 6 months
measure: The acceptance rate for referral in each arm
timeFrame: 6 months
measure: Proportion of patients eligible for referral who had DR and who did not attend
timeFrame: 6 months
Other outcomes:
measure: Barriers to compliance
timeFrame: 6 months
measure: Drivers of acceptance
timeFrame: 6 months
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamil Nadu
Study officials:
affiliation: Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai, India
name: Sanil Joseph, MHA, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Aravind Eye Hospital, Madruai, India
name: Ramasamy Kim, DO, DNB
role: STUDY_CHAIR
affiliation: Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai
name: Thulasiraj Ravilla, MBA
role: STUDY_CHAIR
affiliation: London School of Hygiene and Tropical Medicine
name: Astrid Fletcher, MSc, PhD
role: STUDY_CHAIR
References:
citation: 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.