Confronting Unequal Eye Care in Pennsylvania
1 other identifier
interventional
206
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2010
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2010
CompletedFirst Posted
Study publicly available on registry
August 11, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedApril 10, 2017
April 1, 2017
3.6 years
August 10, 2010
April 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Pt. 1 Risk perceptions of diabetes
6-month follow up assessment
Pt. 1 Diabetes self-care behaviors
6-month follow up assessment
Pt. 1 Depressive Symptoms
6-month follow up assessment
Pt. 2 Appointment Adherence Characteristics
Dependent on Diagnosis
Other Outcomes (1)
Pt. 2 Cost-effectiveness
Conclusion of Study
Study Arms (2)
Pt. 1 Behavioral Activation
EXPERIMENTALBehavioral 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).
Pt. 1 Supportive Therapy
PLACEBO COMPARATORThe 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.
Interventions
Baseline assessment plus 4 in-home problem solving therapy sessions.
Baseline assessment plus 4 in-home sessions of supportive therapy.
Eligibility Criteria
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
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wills Eyelead
- Thomas Jefferson Universitycollaborator
- Temple Universitycollaborator
Study Sites (3)
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Wills Eye Health System
Philadelphia, Pennsylvania, 19107, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Related Publications (3)
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.
PMID: 26068230BACKGROUNDRovner 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.
PMID: 27269487BACKGROUNDPizzi 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.
PMID: 26924099DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julia Haller, MD
Wills Eye
- STUDY DIRECTOR
Lisa Hark, PhD, RD
Wills Eye
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ophthalmologist-in-Chief
Study Record Dates
First Submitted
August 10, 2010
First Posted
August 11, 2010
Study Start
October 1, 2010
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
April 10, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share
Several manuscripts have been published.