Barriers to Eye Screening for People With Diabetes in India

Sponsor
Lions Club International Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT04544553
Collaborator
(none)
200
1
2
6.6
30.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: SMS reminder
  • Other: No SMS reminder
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Screening
Official Title:
To Understand the Barriers and Facilitators of Diabetic Retinopathy Screening & Follow-up: An Exploratory Study From India and Thailand
Actual Study Start Date :
Jan 24, 2019
Actual Primary Completion Date :
Aug 14, 2019
Actual Study Completion Date :
Aug 14, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Attendance rates in patients with diabetic macular edema receiving short messaging services [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rajiv Raman Chennai Tamilnadu India 600006

Sponsors and Collaborators

  • Lions Club International Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rajiv Raman, Senior Consultant (Ophthalmologist), Sankara Nethralaya
ClinicalTrials.gov Identifier:
NCT04544553
Other Study ID Numbers:
  • 731-2018-P
First Posted:
Sep 10, 2020
Last Update Posted:
Sep 14, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rajiv Raman, Senior Consultant (Ophthalmologist), Sankara Nethralaya
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2020