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.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Diabetes Mellitus, Type 2; Diabetic Retinopathy
• Intervention / Treatment: Behavioral: Behavioral Activation; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pt. 1 Behavioral Activation; 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; Baseline assessment plus 4 in-home problem solving therapy sessions.; Other Names: BA - abbreviation
Placebo Comparator: Pt. 1 Supportive Therapy; 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; Baseline assessment plus 4 in-home sessions of supportive therapy.; Other Names: ST-abbreviation

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pt. 2 Cost-effectiveness	To determine which aspects of the intervention are most costly, and whether these aspects can be delivered more efficiently in order to promote broader translation.	Conclusion of Study

Collaborators and Investigators

• Sponsor: Wills Eye
• Collaborators: Temple University; Thomas Jefferson University
• Investigators: Principal Investigator: Julia Haller, MD, Wills Eye; Study Director: Lisa Hark, PhD, RD, Wills Eye

Publications and helpful links

General Publications

• Weiss DM, Casten RJ, Leiby BE, Hark LA, Murchison AP, Johnson D, Stratford S, Henderer J, Rovner BW, Haller JA. Effect of Behavioral Intervention on Dilated Fundus Examination Rates in Older African American Individuals With Diabetes Mellitus: A Randomized Clinical Trial. JAMA Ophthalmol. 2015 Sep;133(9):1005-12. doi: 10.1001/jamaophthalmol.2015.1760.
• Rovner BW, Haller JA, Casten RJ, Murchison AP, Hark LA. Cultural and Cognitive Determinants of Personal Control in Older African Americans with Diabetes. J Natl Med Assoc. 2015 Jun;107(2):25-31. doi: 10.1016/S0027-9684(15)30021-3. Epub 2015 Dec 2.
• Pizzi LT, Tran J, Shafa A, Waisbourd M, Hark L, Murchison AP, Dai Y, Mayro EL, Haller JA. Effectiveness and Cost of a Personalized Reminder Intervention to Improve Adherence to Glaucoma Care. Appl Health Econ Health Policy. 2016 Apr;14(2):229-40. doi: 10.1007/s40258-016-0231-8.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: August 10, 2010
• First Submitted That Met QC Criteria: August 10, 2010
• First Posted (Estimate): August 11, 2010

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Intervention Studies; Cost-effectiveness; African Americans; Vision Screening; Follow-up Care; Personalization of care; Geriatric Assessment; Vision, Low; Diabetic Complications; Cultural Competency; Outcomes Assessment; Cultural Characteristics; Appointment Adherence
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetes Mellitus, Type 2; Diabetic Retinopathy
• Other Study ID Numbers: CURE-1837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Several manuscripts have been published.