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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-22

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Diabetic retinopathy (DR) is a highly specific vascular complication of diabetes mellitus, with prevalence strongly related to a number of risk factors including the duration of diabetes, the level of glycaemic control, etc. Diabetic retinopathy affects over one third of all people with diabetes and is one of the leading causes of vision loss. It is recommended that optimising glycaemic control could reduce the risk or slow the progression of diabetic retinopathy, and that 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. Participants will be randomly assigned to either control or intervention group with a 1:1 allocation as per computer-generated random numbers. A senior onsite manager will monitor participant enrolment over the course of the study. An ophthalmologist-delivered health education will be offered as the intervention in an individualised, face-to-face counselling session to build awareness on diabetes symptoms, particularly on diabetic retinopathy, and its risk factors with appropriate management. All subjects, regardless of the group allocation, will be followed up for 12 months. Baseline and follow-up profiles will be assessed and collected by clinical personnel blind to group allocation. The intervention arm will be compared against the control for all primary analysis. The study was partly supported by the Open Research Funds of the State Key Laboratory of Ophthalmology. Trial results will be disseminated to key stakeholders and the general medical community.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention group

Group Type EXPERIMENTAL

Ophthalmologist-delivered health education

Intervention Type OTHER

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.

Control group

Group Type OTHER

Usual care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Usual care

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 35-80 years
* Clinically diagnosed with type 2 diabetes
* At risk of diabetic retinopathy (DR),e.g. no apparent DR or mild non-proliferative DR
* On regular community care by 'family doctor team' in the context of the National basic public health service delivery

Exclusion Criteria

* With symptoms of cognitive dysfunction, dementia, severe mental disorders, or other conditions with inability to appropriately convey personal thoughts
* Type 1 diabetes or gestational diabetes
* Developed with eye conditions requiring timely treatment, e.g., diabetic macular edema, severe non-proliferative diabetic retinopathy, or proliferative DR
* Have a family member (including relatives) who participated in the trial with a different group assignment
* Currently enrol in other ongoing interventions that may exert additional effects on blood glucose control

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No