CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 206 enrolled
Drug / intervention
Behavioral Activation +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01179555
NCT01179555N/ACompleted

Confronting Unequal Eye Care in Pennsylvania

Wills Eye·interventional·Posted Aug 11, 2010·Updated Apr 10, 2017

In Brief

A clinical study evaluating Behavioral Activation and Supportive Therapy for Diabetic Retinopathy and 2 related conditions. Completed, enrolled 206 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 11, 2010
Enrollment StartOct 1, 2010
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.9 years ago

Interventions

Behavioral Activationbehavioral

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

Supportive Therapybehavioral

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