Confronting Unequal Eye Care in Pennsylvania

Summary

Pt. 1 Diabetic retinopathy is a common eye condition among diabetic adults and can lead to severe vision impairment and even blindness. African Americans are more likely to have vision loss from diabetic retinopathy due to a variety of factors, including cultural barriers to care. The investigators aim to increase the rates of eye exams in diabetic African American adults by providing culturally relevant home-based interventions. These interventions will increase the knowledge about diabetes and the eyes and the awareness of ocular risks due to diabetes.

206 African American adults, over the age of 65, with diabetes will be recruited from primary care clinics at Thomas Jefferson and Temple University. Eligible patients who consent to participate will have baseline information taken about medical and ocular history, understanding of diabetes and a hemoglobin A1C level obtained. The subjects will then be randomized to one of two treatment conditions: Behavioral Activation or Supportive Therapy, each of which will be delivered over 4 sessions. Behavioral Activation will consist of educational materials, referral assistance for eye clinics, and addressing patient specific barriers to care. Supportive Therapy will consist of supportive but non-directional interaction with the patient exploring the impact of aging and diabetes on the patient's life. The investigators hypothesize that more patients who receive Behavioral Activation will have a dilated fundus exam (the primary outcome variable), understand the risks of diabetic complications and feel less depression then subjects who receive Supportive Therapy.

Conditions

• Diabetic Retinopathy
• Diabetes Mellitus, Type 2
• Glaucoma

Interventions

BEHAVIORAL

Behavioral Activation

Baseline assessment plus 4 in-home problem solving therapy sessions.

BEHAVIORAL

Supportive Therapy

Baseline assessment plus 4 in-home sessions of supportive therapy.

Sponsors & Collaborators

• Thomas Jefferson University

  collaborator OTHER

• Temple University

  collaborator OTHER

• Wills Eye

  lead OTHER

Principal Investigators

• Julia Haller, MD · Wills Eye

• Lisa Hark, PhD, RD · Wills Eye

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2014-05-31

Completion

2014-05-31

Countries

• United States

Study Locations