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Completed

NCT Number: NCT01179555

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral Activation

Behavioral

Baseline assessment plus 4 in-home problem solving therapy sessions.

Other names: BA - abbreviation

Supportive Therapy

Behavioral

Baseline assessment plus 4 in-home sessions of supportive therapy.

Other names: ST-abbreviation

Primary outcomes

  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 outcomes

  1. Pt. 1 Risk perceptions of diabetes

    Time frame: 6-month follow up assessment

    Risk Perception Survey-Diabetes Mellitus (RPS-DM) has 5 subscales:

    • 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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • Temple University
  • Thomas Jefferson University

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 11, 2010
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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