Barriers to Eye Screening for People With Diabetes in India

Not Applicable

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Other: No SMS reminder; Other: SMS reminder

• Registration Number: NCT04544553
• Lead Sponsor: Lions Club International Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-24
• Primary Completion: 2019-08-14
• Study Completion: 2019-08-14
• Status Verified: 2020-09
• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-09
• Study First Posted: 2020-09-10
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No SMS reminder	No SMS reminder	This arm did not receive SMS reminder for the follow-up of DR Screening
SMS reminder	SMS reminder	This arm receive SMS reminder for the follow-up of DR Screening

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rajiv Raman; 🇮🇳 Chennai, Tamilnadu, India