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Completed

NCT Number: NCT02334137

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

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).

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Key information

Conditions

Diabetes Complications Cardiovascular Diseases Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iPad app

Behavioral

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

Behavioral

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

Behavioral

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).

Primary outcomes

  1. Change from Baseline in Patient Knowledge about Diabetes at 3 months (via multiple-choice surveys)

    Time frame: Participants will be re-surveyed at their next follow-up eye appointment, an expected average of 3 months post-intervention

    Objective assessment of patient knowledge about diabetes using 13 multiple-choice questions

Secondary outcomes

  1. Change from Baseline Hemoglobin A1c at 3 months

    Time frame: Participants will have repeat lab drawn at their next follow-up eye appointment, an expected average of 3 months post-intervention

    Provides estimate of patient's average blood sugar over past three months

  2. Patient Satisfaction / Motivation / Subjective Improvement in Knowledge (brief surveys)

    Time frame: 1 day

    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

  3. Change from Baseline in Patient Knowledge about Diabetes Immediately after using Educational Services (via multiple-choice surveys)

    Time frame: 1 day

    Objective assessment of patient knowledge about diabetes using 13 multiple-choice questions

Sponsors and collaborators

Lead sponsor

California Pacific Medical Center Research Institute

Other

Collaborators

  • Pacific Vision Foundation

Registry information

Official study title

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

Acronym: LionsDMed

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 8, 2015
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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