NCT01179555

Confronting Unequal Eye Care in Pennsylvania

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Wills Eye · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

An additional aim was added to this project, examining the effect of a telephone intervention on eye care adherence and comparing the efficacy of the intervention to usual care and automated telephone screenings. Glaucoma is a group of chronic, neurodegenerative diseases of the optic nerve, which leads to an increase in intraocular pressure, gradual changes in the visual field (VF), and progressive vision loss. Glaucomatous vision loss is preventable with proper eye care, including adherence to follow-up appointments and medications. Interventions that improve appointment adherence have the potential to prevent more severe glaucomatous disease. The primary purpose of this study is to determine the efficacy of a multifaceted intervention system, which includes a customized letter and personal telephone outreach, in improving appointment adherence in patients with glaucoma. In order to improve strategies to reduce the rate of appointment non-adherence, shared characteristics of adherent versus non-adherent patients with glaucoma will be identified and compared to patient characteristics in the previous literature. A secondary goal of this study is to analyze the cost-effectiveness of this multifaceted intervention on appointment adherence in patients with glaucoma.

Conditions

• Diabetic Retinopathy
• Diabetes Mellitus, Type 2
• Glaucoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2010-08-11
• Last updated: 2017-04-10

Locations

3 sites across 1 country: United States