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

February 8, 2022 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
652

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycated haemoglobin (HbA1c)
Time Frame: 12-months follow-up
Proportion of participants who had optimal control of HbA1c level at 12 months
12-months follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
12-months follow-up
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
12-months follow-up
Body mass index
Time Frame: 12-months follow-up
Use of weight and height to report body mass index in kg/m^2
12-months follow-up
Blood pressure
Time Frame: 12-months follow-up
Use of systolic and diastolic blood pressure to report blood pressure profile in mmHg
12-months follow-up
cholesterol concentration
Time Frame: 12-months follow-up
Use of cholesterol concentration to report lipid profile in mmol/L
12-months follow-up
triglyceride concentration
Time Frame: 12-months follow-up
Use of triglyceride concentration to report lipid profile in mmol/L
12-months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhongshan Ophthalmic Center, Sun Yat-sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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