Expansion of Integrated AI Solution for Diabetic Retinopathy Screening in Thailand

August 31, 2022 updated by: Rajavithi Hospital

Expansion of Integrated AI Solution for Diabetic Retinopathy Screening in Thailand: An Implementation Research

Efficiency and effectiveness of real-world diabetic retinopathy screening by artificial intelligent (AI) are limited. Investigators will implement AI for diabetic retinopathy screening in 13 health districts in Thailand and investigate the efficiency, effectiveness as well as patients and health care personnel's satisfaction by an implementation research.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

34500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All diabetes mellitus patients who visit for diabetic retinopathy screening at selected primary care units and hospitals in 13 health districts in Thailand

Description

Inclusion Criteria:

  1. Type 1 or 2 diabetes mellitus patients whose name are in primary hospital record
  2. No full-time ophthalmologists in those primary hospital
  3. Age more than or equal to 18 years
  4. Eligible for fundus photo imaging at least 1 eye

Exclusion Criteria:

  1. Type 1 or 2 diabetes mellitus patients whose name are in primary hospital record that have full-time ophthalmologists
  2. Patients who previously diagnosed with other causes of macular edema, for example, Age-related Macular Degeneration, Radiation Retinopathy, Retinal Vein Occlusion etc.
  3. History of retinal laser or surgery
  4. Other ocular diseases that require referral to ophthalmologists
  5. Not eligible for fundus photo imaging for both eyes (any causes)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AI screening group
Diabetes mellitus patients undergo diabetic retinopathy screening by AI
Diagnostic test: Diabetic retinopathy screening by artificial intelligence
Screening diabetic patients' eyes with AI through digital health platform
Manual screening group
Diabetes mellitus patients undergo diabetic retinopathy screening by health care personnel
Diagnostic test: Diabetic retinopathy screening by healthcare personnel
Screening diabetic patients' eyes by conventional method (healthcare personnel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of AI in diabetic retinopathy screening
Time Frame: Throughout the whole period of screening, approximately 6 months
Referral adherance of patients in AI group in percentage
Throughout the whole period of screening, approximately 6 months
Efficiency of AI in diabetic retinopathy screening
Time Frame: Throughout the whole period of screening, approximately 6 months
Down time and failure rate of AI system
Throughout the whole period of screening, approximately 6 months
Efficiency of AI in diabetic retinopathy screening
Time Frame: Throughout the whole period of screening, approximately 6 months
Cost in development and implement of AI system in Thai baht unit
Throughout the whole period of screening, approximately 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction of patients and health care personnel in AI-based screening
Time Frame: At the end of the screening, approximately at Month 6
Measurement of health care personnel's satisfaction by well-developed questionnaire
At the end of the screening, approximately at Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajavithi Hospital

Collaborators

Health Systems Research Institute (HSRI), Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 3, 2022

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

September 2, 2022

Last Update Submitted That Met QC Criteria

August 31, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 65057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Fear of inappropriate use of data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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