Clinical trial NCT02334137: A Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits
Official title: Providing Diabetes Services in the Lions Eye Clinic: a Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Complications
Diabetic Retinopathy
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
Collaborators: name: Pacific Vision Foundation
First posted: 2015-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The proposed subjects are diabetic patients already approved to be seen in the Lions Eye Clinic, specifically for dilated eye exam by a retinal specialist. This is a high-risk population with advanced disease and often with limited preexisting knowledge about diabetes, thus providing the motivation for these educational interventions.

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Change from Baseline Hemoglobin A1c at 3 months
timeFrame: Participants will have repeat lab drawn at their next follow-up eye appointment, an expected average of 3 months post-intervention
measure: Patient Satisfaction / Motivation / Subjective Improvement in Knowledge (brief surveys)
timeFrame: 1 day
measure: Change from Baseline in Patient Knowledge about Diabetes Immediately after using Educational Services (via multiple-choice surveys)
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Resident Ophthalmologist, CPMC
name: Samuel J Reiter, MD
role: STUDY_DIRECTOR
affiliation: CPMC Ophthalmologist, Residency Program Director
name: Taliva Martin, MD
role: PRINCIPAL_INVESTIGATOR
References: