An interventional study of Ophthalmologist-delivered health education and Usual care in Diabetes Mellitus, Type 2, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-10.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Prevention
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.
9,357 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 652 is above the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Ophthalmologist-delivered health education
Other: Usual care
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.
Usual care follows standard procedure on diabetes management similar to the routine service provision.
Glycated haemoglobin (HbA1c)
Proportion of participants who had optimal control of HbA1c level at 12 months
Time frame: 12-months follow-up
Treatment burden
Use of treatment burden questionnaire to quantify item scores for each domain, in detail and together, on treatment burden of patients
Time frame: 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
Time frame: 12-months follow-up
Body mass index
Use of weight and height to report body mass index in kg/m\^2
Time frame: 12-months follow-up
Blood pressure
Use of systolic and diastolic blood pressure to report blood pressure profile in mmHg
Time frame: 12-months follow-up
cholesterol concentration
Use of cholesterol concentration to report lipid profile in mmol/L
Time frame: 12-months follow-up
triglyceride concentration
Use of triglyceride concentration to report lipid profile in mmol/L
Time frame: 12-months follow-up
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Zhongshan Ophthalmic Center, Sun Yat-sen University