Clinical trial NCT06968637: Improving Patient-centered Care for Diabetes in Bangladesh Through "Dynamic Integration" of Vision Care on the Supply Side
Official title: Improving Patient-centered Care for Diabetes in Bangladesh Through "Dynamic Integration" of Vision Care on the Supply Side
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Diabetic Retinopathy (DR)
Lead sponsor: Orbis
Sponsor class: OTHER
Collaborators: name: District Diabetes Hospital, Dinajpur district of Bangladesh
name: Gausul Azam BNSB Eye Hospital in the Dinajpur district of Bangladesh
First posted: 2025-05-13
Enrollment: 140
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the intervention group, a Patient Information System (PIS) database will be used, both at the diabetic hospital and eye hospital in Dinajpur. The PIS will be used for referral tracking, to deliver the results of the eye exam to the diabetologist, and, most importantly, based on the result of the DR exam, to provide specific care recommendations for diabetes management. Based on existing guidelines, when DR is present, the PIS will prompt diabetologists to check, and if necessary, change medicines to optimize, blood sugar, blood pressure and lipids. Therefore, through the doctors of the diabetic hospital tracking eye results, the PIS will reinforce the need for the patient to visit both the eye hospital and diabetic hospital for DM/DR management and will improve overall DM care.

In the Control group, information on the DR exam will be conveyed through the PIS without specific care recommendations.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to review if improved patient-centered diabetes mellitus (DM) care, through the integration of vision services utilizing a patient information system (PIS), can promote cooperation between diabetic retinopathy (DR) and DM care providers for participants that are diagnosed with DM and identified with high-risk DR.

The main questions it aims to answer are:

1. What proportion of participants' care meets international guidelines upon chart review by a masked clinician observer, compared between study groups.
2. What is the cost-effectiveness, measured as total intervention cost per additional participant complying with the suggested exam, to improve diabetic care.

Researchers will compare participant adherence with international guidelines when DR results are provided by a PIS without specific care recommendations to when the PIS provides DR results with specific care recommendations for DM management.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with DM
* Diagnosed with high-risk DR
* Over 30 years of age
* Currently treated at the Dinajpur Diabetes Hospital in Bangladesh
* willingness to participate in the study

Exclusion Criteria:

* Other significant causes of vision loss
* Medical conditions that could impair compliance with follow-up (such as stroke, dementia, etc.)
* Not willing to participate in the study

Primary outcomes:
measure: The proportion of participants reaching recommended HgA1c levels among participants with DR, upon chart review by a masked clinician observer, compared between study groups.
timeFrame: From enrollment to chart review (3 months after enrollment)
Secondary outcomes:
measure: The proportion of participants reaching recommended HgA1c levels among all participants with DM, upon chart review by a masked clinician observer, compared between study groups.
timeFrame: From enrollment to chart review (3 months after enrollment)
measure: Cost-effectiveness, measured as total intervention cost per additional patient complying with the suggested exam to improve diabetic care.
timeFrame: Enrollment to chart review (3 months after enrollment)
Other outcomes:
Locations:
city: Dinajpur Sadar
country: Bangladesh
facility: Dinajpur Diabetes & Swasthoseba Hospital
state: Dinajpur
city: Dinajpur district
country: Bangladesh
facility: Gausul Azam BNSB Eye Hospital
Study officials:
affiliation: Orbis Bangladesh
name: Munir Ahmed
role: PRINCIPAL_INVESTIGATOR
affiliation: Orbis
name: Nathan Congdon
role: PRINCIPAL_INVESTIGATOR
References: