A Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits (NCT02334137) | Clinical Trial Compass
CompletedNot Applicable
A Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits
36 participantsStarted 2014-11
Plain-language summary
The overarching purpose of this project is to provide diabetes education to the diverse patient population at the Lions Eye Clinic, a resident-run ophthalmology practice at California Pacific Medical Center. Because of high clinic volume in a teaching environment, our patients often experience long wait times. The goal of this program is to utilize this wait time for diabetes education, a much-needed corollary to the eye care that patients receive at our clinic.
This pilot project will investigate the impact of a program like this in our patient population. Specifically, the investigators are investigating whether diabetes education delivered in an ophthalmology setting enhances patient understanding of diabetes (via knowledge surveys) and/or leads to improved blood glucose control (via hemoglobin A1c). This is a 6-month study that runs through April 2015, and looks at the impact of an interactive diabetes education iPad app +/- in-person sessions with a diabetes educator. A subset of patients who meet with a diabetes educator will also be shown their own retinal images (compared to a normal retina).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Type 1 or Type 2 diabetes (as defined by evident systemic findings OR recent hemoglobin A1c OR patient report, as specific blood sugar data and knowledge of particular medications are often limited in this population)
* Age 18-75
* Able and willing to provide informed consent
* Speak English, Spanish, or any other language for which a translator is present
Exclusion Criteria:
* Advanced visual acuity loss in both eyes which prevents adequate use of educational tools
* Pregnant women, elderly patients (\>75 years old), children and adolescents (17 or younger)
* Non-English/Spanish speakers for whom a translator is not present
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Patient Knowledge about Diabetes at 3 months (via multiple-choice surveys)
Timeframe: Participants will be re-surveyed at their next follow-up eye appointment, an expected average of 3 months post-intervention
Trial details
NCT IDNCT02334137
SponsorCalifornia Pacific Medical Center Research Institute