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Barriers to Eye Screening for People With Diabetes in India

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
SMS reminder
No SMS reminder
Sponsored by
Lions Club International Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetic Macular Edema focused on measuring screening, follow-up, short message service

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rajiv Raman

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

SMS reminder

No SMS reminder

Arm Description

This arm receive SMS reminder for the follow-up of DR Screening

This arm did not receive SMS reminder for the follow-up of DR Screening

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 3, 2020
Last Updated
September 10, 2020
Sponsor
Lions Club International Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04544553
Brief Title
Barriers to Eye Screening for People With Diabetes in India
Official Title
To Understand the Barriers and Facilitators of Diabetic Retinopathy Screening & Follow-up: An Exploratory Study From India and Thailand
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
August 14, 2019 (Actual)
Study Completion Date
August 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lions Club International Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
screening, follow-up, short message service

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMS reminder
Arm Type
Other
Arm Description
This arm receive SMS reminder for the follow-up of DR Screening
Arm Title
No SMS reminder
Arm Type
Other
Arm Description
This arm did not receive SMS reminder for the follow-up of DR Screening
Intervention Type
Other
Intervention Name(s)
SMS reminder
Intervention Description
The group receives reminder for the follow-up at 1 week and 2 days prior to their scheduled appointments.
Intervention Type
Other
Intervention Name(s)
No SMS reminder
Intervention Description
The group did not receives any SMS regarding scheduled appoinments.
Primary Outcome Measure Information:
Title
Attendance rates in patients with diabetic macular edema receiving short messaging services
Description
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.
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rajiv Raman
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600006
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
33691182
Citation
Kumar G, Velu S, Prakash VJ, Kumar S, Sivaprasad S, Sharma A, Raman R. Attendance Rate in Patients with Diabetic Macular Edema Receiving Short Messages. Ophthalmol Retina. 2021 Oct;5(10):1054-1056. doi: 10.1016/j.oret.2021.03.005. Epub 2021 Mar 7. No abstract available.
Results Reference
derived

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Barriers to Eye Screening for People With Diabetes in India

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