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Completed

NCT Number: NCT01744132

Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

The goal of this project is to implement a Collaborative Translational Research Center (TRC) Network Study which aims to assure optimal two-way communication between ophthalmologists and their patients' primary care physicians (PCP). The Collaborative TRC Network Study will have 2 objectives:

* To design and develop common research protocols to develop a 4-year retrospective database (2007-2010) that compiles electronic billing and medical chart information that can be used to study individual-level, clinical-level and system-level factors that impact access to and quality of vision care; * To evaluate adherence to dilated fundus exams (DFEs) follow-up as the primary measureable quality indicator, and its relationship to the patients' demographics, ethnicity, socioeconomic status (SES), severity of diabetic retinopathy (DR), other ocular and medical co-morbidities, presence of HA1C, and primary care provider (PCP) communication.

By enhancing communication and strengthening the clinical information exchanged between PCPs and eye care professionals, this Collaborative TRC Network study will help to overcome barriers to obtaining ongoing DFEs and reduce disparities in vision care utilization.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jefferson Pharmacy

Philadelphia, Pennsylvania, 19107, United States

About this study

Since its inception in October 2010 Collaborative Network Research Study at the Wills Eye Institute has aimed:

  • to establish a retrospective analysis of existing ophthalmic data sets to assess and evaluate system-level and individual-level factors that impact access to and quality of vision care in patients with diabetes;
  • to implement telephone-based and educational interventions to improve DFE follow-up adherence in African Americans with diabetes utilizing a prospective, cluster-based, randomized cohort design;
  • to determine the feasibility and effectiveness of using a non-invasive, non-mydriatic fundus camera (Nidek) in a community-based pharmacy setting to screen and detect diabetic retinopathy and other ocular diseases among individuals with diabetes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

for Aim 1:

  • Age ≥ 18 years
  • Type 2 diabetes mellitus
  • Had a dilated fundus exam (DFE) within the past four years (2007-2010).

Exclusion criteria

for Aim 1:

  • Pregnant women

Inclusion criteria

for Aim 2 and 3:

  • Age ≥ 18 years
  • Type 2 diabetes mellitus
  • Access to a telephone

Treatment and study plan

Aim 3: Contract

Behavioral

Primary outcomes

  1. All Aims: DFE follow-up adherence rate

    Time frame: 2 years

    In Aim 1 and Aim 2 specifically the influence patients' ethnicity and severity of diabetic retinopathy will be examined with the rate of dilated fundus examine (DFE) follow-up adherence.

    In Aim 3, the rate of DFE follow-up adherence will be examined for both patients in the contract and the no contract group.

Secondary outcomes

  1. Aim 3: Rates of ocular disease

    Time frame: 2 years

    In Aim 3, the occurrence of diabetic retinopathy, glaucoma, cataracts, and other ocular diseases will be collected.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Johns Hopkins University
  • University of Alabama at Birmingham
  • University of Miami

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 6, 2012
Registry last updated
Nov 22, 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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