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
1 other identifier
interventional
652
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Jul 2020
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2020
CompletedStudy Start
First participant enrolled
July 22, 2020
CompletedFirst Posted
Study publicly available on registry
July 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFebruary 10, 2022
February 1, 2022
4.4 years
July 22, 2020
February 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Glycated haemoglobin (HbA1c)
Proportion of participants who had optimal control of HbA1c level at 12 months
12-months follow-up
Secondary Outcomes (6)
Treatment burden
12-months follow-up
Patients' adherence
12-months follow-up
Body mass index
12-months follow-up
Blood pressure
12-months follow-up
cholesterol concentration
12-months follow-up
- +1 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALControl group
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2020
First Posted
July 29, 2020
Study Start
July 22, 2020
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
February 10, 2022
Record last verified: 2022-02