A behaviour change technique reminder intervention for diabetic retinopathy screening
| ISRCTN | ISRCTN18167419 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18167419 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 20250367-01H |
| Sponsor | University Health Network |
| Funder | Diabetes Action Canada |
- Submission date
- 18/06/2025
- Registration date
- 07/07/2025
- Last edited
- 18/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims to see if a specially designed health reminder can help encourage people with diabetes to get their eyes tested for diabetic retinopathy. These reminders will be designed with input from the community and translated into four different languages spoken by people in the downtown Ottawa community.
Who can participate?
Adults (18+) who are registered in a local community diabetes education program can be sent a reminder
What does the study involve?
Participants in the study will be randomly assigned to receive an email reminder or no reminder at all. The research will then compare how many people in each group attend and book an eye appointment. It is expected that the participants who receive a reminder will be more likely to attend /book an appointment.
What are the possible risks and benefits of participating?
Participants will benefit from the opportunity to have their eyes tested, especially for those who did not know about diabetic retinopathy or were unable to get their eyes tested before. No risks are expected to be involved with participating in the study. At the end of the study, everyone, including those who did not receive a reminder during the study, will be told about the opportunity to have their eyes tested.
Where is the study run from?
The study is being organized and managed at the Ottawa Hospital Research Institute. The eye appointment booking and patient data will be maintained at the Community Health Centre.
When is the study starting and how long is it expected to run for?
May 2025 to March 2026
Who is funding the study?
This study is being funded by the University Health Network (UHN) and Diabetes Action Canada.
Who is the main contact?
Dr. Justin Presseau, Ottawa Hospital Research Institute, jpresseau@ohri.ca
Dr. Jenny Olson, Ottawa Hospital Research Institute, jolson@ohri.ca
Contact information
Scientific, Principal investigator
The Ottawa Hospital Research Institute
501 Smyth Road
Ottawa
K1H 8L6
Canada
| jpresseau@ohri.ca |
Public, Scientific, Principal investigator
The Ottawa Hospital Research Institute
501 Smyth Road
Ottawa
K1H 8L6
Canada
| jolson@ohri.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre two-arm randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Evaluating the efficacy of a behaviour change technique-based and linguistically tailored e-mail-based reminder to increase attendance to diabetic retinopathy screening |
| Study objectives | This study aims to answer the following: Do linguistically adapted reminders that use behaviour change techniques help people with diabetes in Ottawa schedule and attend their eye screening appointments more than no reminder at all? We expect that, compared to participants in the control group, who will not receive a reminder about diabetic retinopathy screening, participants in the intervention group, who will receive a reminder, will be more likely to book and attend a diabetic retinopathy screening appointment during the trial period. |
| Ethics approval(s) |
Approved 15/05/2025, OHSN-REB (Ottawa Health Science Network Research Ethics Board) (Civic Box 675 725 Parkdale Avenue, Ottawa, K1Y 4E9, Canada; +1 613-798-5555 ext. 16719; REBAdministration@ohri.ca), ref: CRRF ID: 6493 |
| Health condition(s) or problem(s) studied | Diabetic retinopathy (DR) |
| Intervention | Eligible participants will be randomly assigned to the intervention or control condition using SAS statistical software. Arm 1: Control Group - does not receive a reminder, and Arm 2: Reminder Group - receives a behaviour change techniques-based and linguistically tailored electronic reminder. Reminders are distributed using an electronic medical record-integrated patient communications system, where participants receive a link to a webpage reminder encouraging diabetic retinopathy screening, booking, and attendance. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Diabetic retinopathy (DRS) screening attendance is measured using data pulled from a study-specific tab in the participants' electronic medical records, which tracks participant attendance and booking. DRS screening attendance will be measured at the end of the trial, after data collection has closed and the debrief has been sent to all participants. |
| Key secondary outcome measure(s) |
The following secondary outcomes are measured using data pulled from a study-specific tab in the participants' electronic medical records at the end of the trial, after data collection has closed and the debrief has been sent to all participants: |
| Completion date | 30/04/2026 |
Eligibility
| Participant type(s) | Patient, Service user |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 330 |
| Total final enrolment | 330 |
| Key inclusion criteria | 1. Are registered to the Community Diabetes Education Program of Ottawa at the community health centre 2. Have T1DM or T2DM 3. Have consented to virtual communications from CHC 4. Are 18 years of age or older 5. Have an active chart (i.e., chart has been updated within the last two years 6. Have not already attended a DRS appointment with this CHC |
| Key exclusion criteria | 1. Are not registered to the Community Diabetes Education Program of Ottawa at the community health centre 2. Do not have T1DM or T2DM 3. Have not consented to virtual communications from CHC 4. Are not 18 years of age or older 5. Do not have an active chart (i.e., chart has been updated within the last two years 6. Have already attended a DRS appointment at this CHC |
| Date of first enrolment | 01/07/2025 |
| Date of final enrolment | 01/11/2025 |
Locations
Countries of recruitment
- Canada
Study participating centre
Ottawa
K1R 6H5
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (excluding forward sortation area, which will instead be reported as approximate distance to community health centre location). Data will be available for 10 years post publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 04/06/2025 | 18/11/2025 | No | No |
Additional files
- ISRCTN18167419 Protocol 04Jun2025.pdf
- Protocol file
Editorial Notes
18/11/2025: Uploaded protocol (not peer-reviewed) as an additional file.
14/11/2025: The following changes were made to the trial record:
1. The completion date was changed from 30/03/2026 to 30/04/2026
2.The total final enrolment was added.
19/06/2025: Study's existence confirmed by the Ottawa Health Science Network Research Ethics Board.
