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

Aravind Eye Care System

Status: Completed

Conditions: Diabetic Retinopathy

Treatments: Other: Conventional referral; Other: Tele-medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT02085681

WT097685MA

Details and patient eligibility

About

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

Full 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.

Enrollment: 801 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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801 participants in 2 patient groups

Tele-medicine

Experimental group

Description:

Tele-medicine aided retinal imaging and referral to eye hospital

Treatment:

Other: Tele-medicine

Conventional Referral

Other group

Description:

Patients will be counselled on the importance of eye examination and will be referred to the eye hospital in the conventional manner.

Treatment:

Other: Conventional referral