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

Study Overview
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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.

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.

Official Title
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The Effectiveness of Ophthalmologist-delivered Health Education on Top of Routine Community Care in Type 2 Diabetic Patients at Risk for Diabetic Retinopathy: A Parallel-group, Randomised Trial

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Ophthalmologist-delivered health education
* Other: Usual care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Other: Ophthalmologist-delivered health education<br>* 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.<br>|
| Other: Control group<br> | Other: Usual care<br>* Usual care follows standard procedure on diabetes management similar to the routine service provision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated haemoglobin (HbA1c) | Proportion of participants who had optimal control of HbA1c level at 12 months | 12-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment burden | Use of treatment burden questionnaire to quantify item scores for each domain, in detail and together, on treatment burden of patients | 12-months follow-up | 
| Patients' adherence | Use of adherence questionnaire to examine the extent to which physician advice, in detail and together, are adhered to by patients | 12-months follow-up | 
| Body mass index | Use of weight and height to report body mass index in kg/m^2 | 12-months follow-up | 
| Blood pressure | Use of systolic and diastolic blood pressure to report blood pressure profile in mmHg | 12-months follow-up | 
| cholesterol concentration | Use of cholesterol concentration to report lipid profile in mmol/L | 12-months follow-up | 
| triglyceride concentration | Use of triglyceride concentration to report lipid profile in mmol/L | 12-months follow-up |