A Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits

Diabetic Retinopathy Clinical Trial

— LionsDMed  

Official title:

Providing Diabetes Services in the Lions Eye Clinic: a Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334137
• Other study ID #: Diabetes Ed at Lions Eye
• Status: Completed
• Phase: N/A
• First received: December 31, 2014
• Last updated: July 25, 2016
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: California Pacific Medical Center Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetic Retinopathy

Intervention

Behavioral:
• iPad app
Provided by the Patient Education Institute, the "X-plain" iPad app includes modules on healthy eating for diabetics, eye complications, foot care, and others.
• Educator sessions
A certified diabetes educator and/or registered dietitian will meet with patients for 30-60 minutes prior to their ophthalmology visits, when scheduling permits.
• Retinal photos
A resident ophthalmologist will spend approximately 5 minutes showing patient their own retinal photos, compared to a normal retina, and explaining the pathology present (if applicable).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
California Pacific Medical Center Research Institute	Pacific Vision Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Patient Knowledge about Diabetes at 3 months (via multiple-choice surveys)	Objective assessment of patient knowledge about diabetes using 13 multiple-choice questions	Participants will be re-surveyed at their next follow-up eye appointment, an expected average of 3 months post-intervention	No
Secondary	Change from Baseline Hemoglobin A1c at 3 months	Provides estimate of patient's average blood sugar over past three months	Participants will have repeat lab drawn at their next follow-up eye appointment, an expected average of 3 months post-intervention	No
Secondary	Patient Satisfaction / Motivation / Subjective Improvement in Knowledge (brief surveys)	Brief 3-4 question surveys to assess patient satisfaction with services offered, motivation to manage their disease process, and subjective improvement in knowledge after using educational services	1 day	No
Secondary	Change from Baseline in Patient Knowledge about Diabetes Immediately after using Educational Services (via multiple-choice surveys)	Objective assessment of patient knowledge about diabetes using 13 multiple-choice questions	1 day	No