Clinical trial NCT01179555: Confronting Unequal Eye Care in Pennsylvania
Official title: Confronting Unequal Eye Care in Pennsylvania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Diabetes Mellitus, Type 2
Glaucoma
Keywords: 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
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
name: Temple University
First posted: 2010-08-11
Enrollment: 206
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pt. 1 Dilated Fundus Exam (DFE)
timeFrame: 6-month follow-up assessment
Secondary outcomes:
measure: Pt. 1 Risk perceptions of diabetes
timeFrame: 6-month follow up assessment
measure: Pt. 1 Diabetes self-care behaviors
timeFrame: 6-month follow up assessment
measure: Pt. 1 Depressive Symptoms
timeFrame: 6-month follow up assessment
measure: Pt. 2 Appointment Adherence Characteristics
timeFrame: Dependent on Diagnosis
Other outcomes:
measure: Pt. 2 Cost-effectiveness
timeFrame: Conclusion of Study
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Wills Eye
name: Julia Haller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wills Eye
name: Lisa Hark, PhD, RD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.