Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Confronting Unequal Eye Care in Pennsylvania
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.
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.
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