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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Ophthalmologist-delivered health education; Other: Usual care

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 652
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuting LI, MPH; Phone Number: +86-020-87334687; Email: liyuting@gzzoc.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Yuting LI, MPH; Phone Number: +86-020-87334687; Email: liyuting@gzzoc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	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.
Other: Control group	Other: Usual care; Usual care follows standard procedure on diabetes management similar to the routine service provision.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Collaborators: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2020
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: SYSU-OPH-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No