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Confronting Unequal Eye Care in Pennsylvania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01179555
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : April 10, 2017
Thomas Jefferson University
Temple University
Information provided by (Responsible Party):
Julia Haller, Wills Eye

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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Diabetes Mellitus, Type 2 Glaucoma Behavioral: Behavioral Activation Behavioral: Supportive Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Confronting Unequal Eye Care in Pennsylvania
Study Start Date : October 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

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 Name: 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 Name: ST-abbreviation

Primary Outcome Measures :
  1. Pt. 1 Dilated Fundus Exam (DFE) [ Time Frame: 6-month follow-up assessment ]
    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

Secondary Outcome Measures :
  1. Pt. 1 Risk perceptions of diabetes [ Time Frame: 6-month follow up assessment ]

    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

  2. Pt. 1 Diabetes self-care behaviors [ Time Frame: 6-month follow up assessment ]
    Yields a global scale that summarizes self-care behaviors

  3. Pt. 1 Depressive Symptoms [ Time Frame: 6-month follow up assessment ]
    Patient Health Questionnaire-9 (PHQ-9)

  4. Pt. 2 Appointment Adherence Characteristics [ Time Frame: Dependent on Diagnosis ]
    To assess the relationship between appointment adherence and particular demographic characteristics, clinical factors, and systems-level variables.

Other Outcome Measures:
  1. Pt. 2 Cost-effectiveness [ Time Frame: Conclusion of Study ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01179555

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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Wills Eye Health System
Philadelphia, Pennsylvania, United States, 19107
Temple University
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Wills Eye
Thomas Jefferson University
Temple University
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Principal Investigator: Julia Haller, MD Wills Eye
Study Director: Lisa Hark, PhD, RD Wills Eye

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Julia Haller, Ophthalmologist-in-Chief, Wills Eye Identifier: NCT01179555     History of Changes
Other Study ID Numbers: CURE-1837
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Several manuscripts have been published.
Keywords provided by Julia Haller, Wills Eye:
Diabetic Complications
Intervention Studies
African Americans
Vision Screening
Vision, Low
Geriatric Assessment
Outcomes Assessment
Cultural Characteristics
Cultural Competency
Appointment Adherence
Personalization of care
Follow-up Care
Additional relevant MeSH terms:
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Diabetic Retinopathy
Diabetes Mellitus, Type 2
Eye Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Retinal Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications