Identifying and contacting people living with diabetes in Canada who may need their eyes examined for signs of retinopathy: a mixed methods study
| ISRCTN | ISRCTN73168630 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73168630 |
| ClinicalTrials.gov (NCT) | NCT05074342 |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Pro00132494 |
| Sponsor | Toronto General Hospital Research Institute |
| Funders | Canadian Institutes of Health Research, Diabetes Canada |
- Submission date
- 28/04/2025
- Registration date
- 01/08/2025
- Last edited
- 22/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Over time diabetes may cause changes in the back of your eyes and blur your vision (known as diabetic retinopathy). By examining your eyes on a regular basis, these changes can be detected and, if needed, treatments can be provided to prevent blindness. The Canadian recommendation for individuals with diabetes is to monitor their eyes once a year, but not all individuals with diabetes have their eyes checked on a regular basis. This study is using provincial health information available to identify individuals who have not had your eyes examined by an eye care professional (for example, an ophthalmologist or optometrist) within the last 425 days (1 year and 2 months) and will be contacted by your primary care practitioner about eye care screening. The aim of the study is to increase the screening rate of individuals who are at risk for diabetic retinopathy within the primary care setting, and to refer to treatment for those at risk of vision loss.
Who can participate?
Individuals 18 years or older who are living with diabetes (Type 1 or Type 2) who have been identified in provincial databases (Alberta, Newfoundland & Labrador, British Columbia and Ontario) as needing their eyes looked at for retinopathy.
What does the study involve?
For those individuals who are called by their primary care centre, to have their eyes looked at for signs of diabetic retinopathy, they will be asked if they wish to either come to the centre for an appointment or referred to either an optometrist or ophthalmologists. If required, they will be sent for treatment. Some of the people contacted will also be asked if they are willing to participate in an interview or focus group to talk about their eye care and what they think about how the healthcare system supports their care or challenges they may have.
What are the possible benefits and risks of participating?
There are no direct benefits to participating in the study. The information learned from this study may help patients in the future by improving health systems and delivery of eye screening for individuals living with diabetes. It is not possible to know all of the risks that may happen in a study, but the researchers have taken all reasonable safeguards to minimize any known risks to a study participant.
Where is the study run from?
The study is being run at primary care centres in Alberta, Newfoundland & Labrador, British Columbia and Ontario (Canada)
When is the study starting and how long is it expected to run for?
The study is starting to call individuals in Alberta in the summer of 2025 and will be beginning in Newfoundland & Labrador and British Columbia in 2026. Interviews are ongoing in Ontario. The study is scheduled to end in March 2027.
Who is funding the study?
The study is funded by the Canadian Institutes of Health Research and Diabetes Canada.
Who is the main contact?
Valeria Rac, Valeria.rac@theta.utoronto.ca or Valeria.Rac@uhn.ca
Donna Manca, dpmanca@ualberta.ca
Jim Bowen, jim.bowen@uhn.ca
Contact information
Principal investigator
200 Elizabeth Street
Toronto
M5G 2C4
Canada
 ORCID ID |
0000-0002-0426-4594 |
|---|---|
| Phone | +1 (0)416 634 8799 |
| valeria.rac@theta.utoronto.ca |
Scientific
#6-10, 8303 112 St. NW (University Terrace)
Edmonton
T6G 2T4
Canada
| ORCID ID |
0000-0001-6073-7715 |
|---|---|
| Phone | +1 (0)780 492 8102 |
| dpmanca@ualberta.ca |
Public
200 Elizabeth Street
Toronto
M5G 2C4
Canada
| ORCID ID |
0000-0002-6457-2337 |
|---|---|
| Phone | +1 (0)416 634 8807 |
| jim.bowen@uhn.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Longitudinal convergent mixed-methods comparative study using an implementation-effectiveness hybrid approach |
| Secondary study design | Effectiveness-implementation hybrid design |
| Scientific title | Guiding primary care diabetic retinopathy screening in Canada through the use of provincial healthcare administrative data |
| Study acronym | DRS in Canada |
| Study objectives | The provision of a diabetic retinopathy screening (DRS) status list to primary health care settings will increase the rate of annual DRS in patients with type 1 or type 2 diabetes who have attended the centres. |
| Ethics approval(s) |
1. Approved 06/12/2023, Health Research Ethics Board (8440 112 St. NW, Edmonton, Alberta, T6G 2R7, Canada; +1 (0)780 492 3111; reoffice@ualberta.ca), ref: Pro00132494/pSite-23-0060 2. Approved 11/02/2021, University Health Network Research Ethics Board (700 University Avenue, 4th Floor, Toronto, M5G 1Z5, Canada; +1 (0)416 581 7849; reb@uhn.ca), ref: 20-5249 |
| Health condition(s) or problem(s) studied | Diabetic retinopathy |
| Intervention | The diabetic retinopathy screening intervention consists of 1) participant identification using provincial healthcare administrative data to identify individuals, followed by 2 ) outreach by primary healthcare settings to contact the unscreened patients, explaining the need for retinopathy screening, and how it differs from a routine eye examination that they may have had previously for glasses and activate referral for retinopathy screening. Contact methods will be aligned with current practices within the primary health care setting, including telephone, direct mail, face-to-face appointments, and email and group sessions. 3) Diabetic retinopathy screening using local Tele-Retina services. 4) Program assessment and examination of the diabetic retinopathy screening and diabetic retinopathy treatment and other eye care utilization patterns and volumes up to 12 months following the completion of the outreach program. |
| Intervention type | Other |
| Primary outcome measure(s) |
Clinical Evaluation Study: |
| Key secondary outcome measure(s) |
Implementation Study: |
| Completion date | 31/03/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 2000 |
| Key inclusion criteria | 1. At least 18 years of age 2. Type 1 or type 2 diabetes as determined through linked provincial healthcare administrative datasets or primary care data using algorithms similar to provincial methods 3. Attended the primary health care setting, with at least one visit to the centre within the past 10 years |
| Key exclusion criteria | 1. Individuals identified as having received diabetic retinopathy screening (in the previous 425 days) by an ophthalmologist and/or optometrist or tele-ophthalmology/Tele-Retina |
| Date of first enrolment | 01/03/2025 |
| Date of final enrolment | 30/09/2026 |
Locations
Countries of recruitment
- Canada
Study participating centres
Westlock, Alberta
T7P 2K4
Canada
156 Street & 87 Avenue
Edmonton, Alberta
T5R 5W9
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available, Data sharing statement to be made available at a later date |
| IPD sharing plan | Some of the datasets generated and/or analysed during the current study are not expected to be made available as they are provincial healthcare administrative data. |
Editorial Notes
29/04/2025: Study's existence confirmed by the Health Research Ethics Board.
