Barriers to Eye Screening for People With Diabetes in India

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04544553
• Other study ID #: 731-2018-P
• Status: Completed
• Phase: N/A
• Start date: January 24, 2019
• Est. completion date: August 14, 2019

Study information

• Verified date: September 2020
• Source: Lions Club International Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 14, 2019
• Est. primary completion date: August 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Other:
• SMS reminder
The group receives reminder for the follow-up at 1 week and 2 days prior to their scheduled appointments.
• No SMS reminder
The group did not receives any SMS regarding scheduled appoinments.

Locations

Country	Name	City	State
India	Rajiv Raman	Chennai	Tamilnadu

Sponsors (1)

Lead Sponsor	Collaborator
Lions Club International Foundation

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance rates in patients with diabetic macular edema receiving short messaging services	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