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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
| |
| Control group | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ophthalmologist-delivered health education | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated haemoglobin (HbA1c) | Proportion of participants who had optimal control of HbA1c level at 12 months | 12-months follow-up |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuting LI, MPH | Contact | +86-020-87334687 | liyuting@gzzoc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual care | Other | Usual care follows standard procedure on diabetes management similar to the routine service provision. |
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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 |
| D004700 | Endocrine System Diseases |