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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Aravind Eye Care System
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Sanil Joseph, Aravind Eye Care System
ClinicalTrials.gov Identifier:
NCT02085681
First received: February 5, 2014
Last updated: March 8, 2014
Last verified: March 2014
  Purpose

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 Intervention
Diabetic Retinopathy
Other: Tele-medicine
Other: Conventional referral

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Aravind Eye Care System:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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 ]
    Patients will be interviewed to identify the factors that encouraged them to visit the eye hospital following referral


Estimated Enrollment: 616
Study Start Date: March 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Tele-medicine aided retinal imaging
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

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02085681

Contacts
Contact: Sanil Joseph, MHA, MSc +914524356500 ext 522 sanil@aravind.org
Contact: Thulasiraj Ravilla, MBA +914524356500 ext 526 thulsi@aravind.org

Locations
India
Aravind Eye Hospital Not yet recruiting
Madurai, Tamil Nadu, India, 625020
Contact: Sanil Joseph, MHA    +914524356500 ext 522    sanil@aravind.org   
Contact: Thulasiraj Ravilla, MBA    +914524356500 ext 526    thulsi@aravind.org   
Principal Investigator: Sanil Joseph, MHA, MSc         
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
  More Information

No publications provided

Responsible Party: Sanil Joseph, Faculty, Aravind Eye Care System
ClinicalTrials.gov Identifier: NCT02085681     History of Changes
Other Study ID Numbers: WT097685MA
Study First Received: February 5, 2014
Last Updated: March 8, 2014
Health Authority: India: Institutional Review Board

Keywords provided by Aravind Eye Care System:
Diabetic Retinopathy
Screening
Tele-medicine
Retinal Imaging
Remote diagnosis

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014