A Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits
LionsDMed
Providing Diabetes Services in the Lions Eye Clinic: a Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits
1 other identifier
observational
36
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 31, 2014
CompletedFirst Posted
Study publicly available on registry
January 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 27, 2016
January 1, 2016
7 months
December 31, 2014
July 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Change from Baseline Hemoglobin A1c at 3 months
Participants will have repeat lab drawn at their next follow-up eye appointment, an expected average of 3 months post-intervention
Patient Satisfaction / Motivation / Subjective Improvement in Knowledge (brief surveys)
1 day
Change from Baseline in Patient Knowledge about Diabetes Immediately after using Educational Services (via multiple-choice surveys)
1 day
Study Arms (3)
iPad app
This group will have unlimited access to educational iPad app while waiting for ophthalmology visits.
Educator sessions
This group will have unlimited access to educational iPad app AND at least one appointment with a certified diabetes educator or registered dietitian while waiting for ophthalmology visits.
Educator sessions + retinal photos
This group will have same access as "iPad app + education sessions" and in addition will be able to briefly review their own retinal photos (compared to normal retina) with a resident ophthalmologist during timeline of pilot program.
Interventions
Provided by the Patient Education Institute, the "X-plain" iPad app includes modules on healthy eating for diabetics, eye complications, foot care, and others.
A certified diabetes educator and/or registered dietitian will meet with patients for 30-60 minutes prior to their ophthalmology visits, when scheduling permits.
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).
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Samuel J Reiter, MD
Resident Ophthalmologist, CPMC
- PRINCIPAL INVESTIGATOR
Taliva Martin, MD
CPMC Ophthalmologist, Residency Program Director
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 31, 2014
First Posted
January 8, 2015
Study Start
November 1, 2014
Primary Completion
June 1, 2015
Study Completion
December 1, 2015
Last Updated
July 27, 2016
Record last verified: 2016-01