Barriers to Eye Screening for People With Diabetes in India

September 10, 2020 updated by: Rajiv Raman, Lions Club International Foundation

To Understand the Barriers and Facilitators of Diabetic Retinopathy Screening & Follow-up: An Exploratory Study From India and Thailand

Brief Summary: Diabetic retinopathy (DR) is a leading cause of visual impairment and has major public health implications globally and especially in countries such as India where the prevalence of diabetes is high. With timely screening and intervention, the disease progression to blindness can be prevented but several barriers exist to the provision of care. The long term aim is to identify the barriers to DR screening and to plan potential interventional strategies. From the qualitative study, the reasons such as lack of awareness or knowledge, distance to travel, lack of reminder system were identified as a reason for poor follow-up. This lead to the development of interventional strategies.

This was a randomized, investigator-masked clinical trial that was conducted in a tertiary eye care centre in South India. Consecutive patients with diabetes who were residents in Chennai and its vicinity of approximately 100 km radius and who were undergoing repeated intravitreal injections for DME were recruited into the trial. The aim of the study is to investigate the effect of SMS informational reminders among patients with Diabetic macular edema for the follow-up. They study consists of 2 groups, SMS reminder group receives the reminders 1 week and 2 days prior to the scheduled appointments with the concerned doctor on a particular date and time, whereas other group does not receive any reminders for the appointment schedule. After the follow-up, the patients will be screened for the attendance at the review visit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600006
        • Rajiv Raman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults with > 40 years of age
  • Diagnosed as centre involving Diabetic macular edema (DME)
  • Patients who received intravitreal injections for DME
  • Ability to give informed consent

Exclusion Criteria:

  • Patients from outside the area of residence who stayed more than 100 km from the hospital
  • Patients with ocular co-morbidities other than DME

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: SMS reminder
This arm receive SMS reminder for the follow-up of DR Screening
Other: SMS reminder
The group receives reminder for the follow-up at 1 week and 2 days prior to their scheduled appointments.
Other: No SMS reminder
This arm did not receive SMS reminder for the follow-up of DR Screening
Other: No SMS reminder
The group did not receives any SMS regarding scheduled appoinments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance rates in patients with diabetic macular edema receiving short messaging services
Time Frame: 7 months
To investigate the effect of SMS informational reminders on adherence with scheduled eye examinations among patients with center involving DME receiving intravitreal injections in a tertiary eye care institute in South India.
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lions Club International Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2019

Primary Completion (Actual)

August 14, 2019

Study Completion (Actual)

August 14, 2019

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

September 14, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 731-2018-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets generated during and/or analysed during the study are not publicly available, as it against the organization hospital policy. But are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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