Confronting Unequal Eye Care in Pennsylvania

Completed · Not applicable

Conditions studied: Diabetic Retinopathy, Diabetes Mellitus, Type 2, Glaucoma

In brief

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.

Key facts

Study ID

NCT01179555

Run by

Wills Eye

People needed

206

Starts

2010-10-01

Expected to finish

2014-05-01

Last updated by the study team

2017-04-10

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• African-American race (self-identified)
• Age ≥ 65 years
• Type II Diabetes Mellitus (physician diagnosis) for at least 1 year
• No medical documentation of a DFE by an ophthalmologist or an optometrist within the past 12 months
• Self-report of no DFE within the past 12 months

You may not qualify if…

• Cognitive Impairment (Mini-Mental Status Examination ≤ 24)
• Current clinically significant psychiatric disorder other than depression
• Current medical disorder that limits life expectancy (≤ 12 months) or need for dialysis
• Hearing impairment that precludes research participation
• Pt. 2
• Inclusion Criteria:
• Glaucoma (physician diagnosis)
• Scheduled for a follow-up appointment that meets the American Academy of Ophthalmology (AAO) follow-up guidelines
• Attended the Wills Eye Glaucoma Clinic from September 1, 2012 to October 31, 2013
• Age ≥ 21 years old
• Able to understand and speak English
• Exclusion Criteria:
• Diagnosed with a pre-existing medical condition that would preclude the subject from providing reliable and valid data
• Individual was asked to follow-up in less than a month.

Where it is running

• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Wills Eye Health System — Philadelphia, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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