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A Trial on Ophthalmologist-delivered Health Education on Top of Routine Community Care

NCT04490941 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 652

Last updated 2022-02-10

No results posted yet for this study

Summary

Diabetic retinopathy affects over one third of all people with diabetes and is one of the leading causes of vision loss. The management of diabetes and its complications should include screening for diabetic retinopathy. A randomised trial is therefore needed of the use of a simple and widely practicable approach to explore the integration of eye care in managing diabetes. The trial is designed as a randomised, controlled, superiority trial. The aim is to explore the effectiveness of ophthalmologist-delivered health education on top of routine community care on blood glucose and eye-related clinical outcomes in type 2 diabetic patients at risk for diabetic retinopathy.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

OTHER

Ophthalmologist-delivered health education

The educational intervention will be conducted on-site by a qualified, experienced ophthalmologist at an ophthalmic center with goals of building awareness on diabetes symptoms, particularly on diabetic retinopathy, and its risk factors with appropriate management.

OTHER

Usual care

Usual care follows standard procedure on diabetes management similar to the routine service provision.

Sponsors & Collaborators

  • Sun Yat-sen University

    collaborator OTHER

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04490941 on ClinicalTrials.gov