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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2024

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Intervention group
  • Other: Control group

Clinical Trial Outcome Measures

Primary Measures

  • Glycated haemoglobin (HbA1c)
    • Time Frame: 12-months follow-up
    • Proportion of participants who had optimal control of HbA1c level at 12 months

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Collaborator
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Yuting LI, MPH, +86-020-87334687, liyuting@gzzoc.com

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