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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04490941
• Other study ID #: SYSU-OPH-007
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2022
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Yuting LI, MPH
• Phone: +86-020-87334687
• Email: liyuting[@]gzzoc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 652
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University	Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated haemoglobin (HbA1c)	Proportion of participants who had optimal control of HbA1c level at 12 months	12-months follow-up
Secondary	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
Secondary	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
Secondary	Body mass index	Use of weight and height to report body mass index in kg/m^2	12-months follow-up
Secondary	Blood pressure	Use of systolic and diastolic blood pressure to report blood pressure profile in mmHg	12-months follow-up
Secondary	cholesterol concentration	Use of cholesterol concentration to report lipid profile in mmol/L	12-months follow-up
Secondary	triglyceride concentration	Use of triglyceride concentration to report lipid profile in mmol/L	12-months follow-up