Improving Patient-centered Care for Diabetes in Bangladesh Through "Dynamic Integration" of Vision Care on the Demand Side

NCT06968611 | Recruiting

• 1 other identifier: PIS-DR-DEMAND-2025
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to determine whether there is an increase in participant uptake of diabetes mellitus (DM) and diabetic retinopathy (DR) services and improved quality of patient-centered diabetic care resulting from the use of automated voice message reminders to sensitize people with DM about the potential for sight loss alongside the provision of free reading glasses. The main questions it aims to answer are:

1. 1.Will the proportion of patients completing their scheduled DR and DM appointments within 3 weeks of the scheduled date be significantly increased in the group receiving the automated voice messages containing both appointment reminders and messaging about the importance of visit and medication compliance in reducing the risk of vision loss, compared with participant messages which only remind them of their appointments?
2. 2.What is the cost-effectiveness, measured as total intervention cost per additional patient complying with the suggested exam?

Conditions

Diabetes Mellitus; Diabetic Retinopathy (DR)

Outcome Measures

Primary Outcomes (1)

• Proportion of patients completing their diabetes or DR exam within 3 weeks of the scheduled date.

  3 weeks following scheduled exam date

Secondary Outcomes (1)

• Cost-effectiveness, measured as total intervention cost per additional patient adherence with the suggested exam.

  Enrollment to 3 weeks following suggested exam date

Study Arms (2)

Control Group: Automated voice message exam reminder only

NO INTERVENTION

Participants will only receive an automated voice message reminder about the date of exam

Intervention Group: Automated voice message + vision education + free reading glasses at appointment

EXPERIMENTAL

Participants will receive an automated voice message reminder about the date of the exam. Additionally, the participant will receive a message underscoring the risk of vision loss from poorly controlled DM, stressing that excellent compliance with visits and medications nearly completely eliminates this risk, and the participant will receive a free pair of reading glasses on first appointment.

Other: Education/information of risk; Other: Free eye glasses

Interventions

Education/information of risk OTHER

Participant will receive a message underscoring risk of vision loss from poorly controlled DM, and how this risk can be largely eliminated with excellent compliance with mediations and clinical visits.

Intervention Group: Automated voice message + vision education + free reading glasses at appointment

Free eye glasses OTHER

Participants will receive a free pair of reading glass at their first appointment

Intervention Group: Automated voice message + vision education + free reading glasses at appointment

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with DM within the last 6 months
• Over 30 years of age
• Currently treated at the Dinajpur Diabetes Hospital
• Possess a mobile phone to receive voice messages
• Willingness to participate in the study, and ability to give informed consent

You may not qualify if:

• Other significant causes of vision loss
• Medical conditions that could impair compliance with follow-up (such as stroke, dementia, etc.)

Sponsors & Collaborators

• Orbis: lead
• District Diabetes Hospital, Dinajpur district of Bangladesh: collaborator
• Gausul Azam BNSB Eye Hospital, Dinajpur district of Bangladesh: collaborator

Study Sites (2)

Gausul Azam BNSB Eye Hospital

Dinajpur, Bangladesh

RECRUITING

Dinajpur Diabetes & Swasthoseba Hospital

Dinajpur Sadar, Bangladesh

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Munir Ahmed

  Orbis Bangladesh

  PRINCIPAL INVESTIGATOR

• Nathan Congdon

  Orbis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lutful Husain

CONTACT

+88 01711626852; lutful.husain@orbis.org

Nathan Congdon

CONTACT

+44 7748751393; ncongdon1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

BA (2)