Confronting Unequal Eye Care in Pennsylvania

Study Overview
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Brief Summary
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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
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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.

Official Title
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Confronting Unequal Eye Care in Pennsylvania

Conditions
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Diabetic Retinopathy, Diabetes Mellitus, Type 2, Glaucoma

Intervention / Treatment
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* Behavioral: Behavioral Activation
* Behavioral: Supportive Therapy


Participation Criteria
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Eligibility Criteria
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Pt. 1 Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pt. 1 Behavioral Activation<br>Behavioral Activation (BA) is a behavioral technique to help people overcome avoidant tendencies through goal setting, activity scheduling, and graded task assignment. The key component of BA involves developing an Action Plan, and having the subject document each step of the plan as he or she implements it, reinforcing the steps towards goal attainment. Action Plans are easily applied to diabetes self-care tasks because the latter lend themselves to documentation of simple, step-by-step plans. In this study, a Community Health Educator (CHE) - interventionist will schedule and deliver four 45-60 minute in-home BA sessions within 3 months of randomization (i.e., one session every 2-3 weeks). | Behavioral: Behavioral Activation<br>* Baseline assessment plus 4 in-home problem solving therapy sessions.<br>* Other names: BA - abbreviation;|
| Placebo Comparator: Pt. 1 Supportive Therapy<br>The purpose of Supportive Therapy (ST) is to explore the impact of aging and diabetes on the subject's life. In contrast to the BA intervention, the interventionist does not discuss the importance of dilated eye exams. In subsequent sessions, ST facilitates and deepens knowledge about the subject's life situation in relation to his or her health and other life difficulties. The ST therapist encourages this process and creates an accepting, nondirective, and supportive opportunity for discussion. | Behavioral: Supportive Therapy<br>* Baseline assessment plus 4 in-home sessions of supportive therapy.<br>* Other names: ST-abbreviation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pt. 1 Dilated Fundus Exam (DFE) | At the 6-month follow-up assessment, patients will be asked if they got a dilated fundus exam since the baseline assessment. If a DFE is self-reported, it will be confirmed by ophthalmology chart review | 6-month follow-up assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pt. 1 Risk perceptions of diabetes | Risk Perception Survey-Diabetes Mellitus (RPS-DM) has 5 subscales: 1) Personal Control, 2) Optimistic Bias, 3) Personal Disease Risk, 4) Comparative Environmental Risk, 5) Risk Knowledge | 6-month follow up assessment | 
| Pt. 1 Diabetes self-care behaviors | Yields a global scale that summarizes self-care behaviors | 6-month follow up assessment | 
| Pt. 1 Depressive Symptoms | Patient Health Questionnaire-9 (PHQ-9) | 6-month follow up assessment | 
| Pt. 2 Appointment Adherence Characteristics | To assess the relationship between appointment adherence and particular demographic characteristics, clinical factors, and systems-level variables. | Dependent on Diagnosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Complications, Intervention Studies, African Americans, Vision Screening, Vision, Low, Geriatric Assessment, Outcomes Assessment, Cultural Characteristics, Cultural Competency, Appointment Adherence, Cost-effectiveness, Personalization of care, Follow-up Care