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Confronting Unequal Eye Care in Pennsylvania

This study has been completed.
Sponsor:
Collaborators:
Thomas Jefferson University
Temple University
Information provided by (Responsible Party):
Julia Haller, Wills Eye
ClinicalTrials.gov Identifier:
NCT01179555
First received: August 10, 2010
Last updated: April 6, 2017
Last verified: April 2017
August 10, 2010
April 6, 2017
October 2010
May 2014   (Final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT01179555 on ClinicalTrials.gov Archive Site
  • 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

  • Pt. 1 Diabetes self-care behaviors [ Time Frame: 6-month follow up assessment ]
    Yields a global scale that summarizes self-care behaviors
  • Pt. 1 Depressive Symptoms [ Time Frame: 6-month follow up assessment ]
    Patient Health Questionnaire-9 (PHQ-9)
  • 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.
  • 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

  • Diabetes self-care behaviors [ Time Frame: 6-month follow up assessment ]
    Yields a global scale that summarizes self-care behaviors
  • Depressive Symptoms [ Time Frame: 6-month follow up assessment ]
    Patient Health Questionnaire-9 (PHQ-9)
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.
Not Provided
 
Confronting Unequal Eye Care in Pennsylvania
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Diabetic Retinopathy
  • Diabetes Mellitus, Type 2
  • Glaucoma
  • Behavioral: Behavioral Activation
    Baseline assessment plus 4 in-home problem solving therapy sessions.
    Other Name: BA - abbreviation
  • Behavioral: Supportive Therapy
    Baseline assessment plus 4 in-home sessions of supportive therapy.
    Other Name: ST-abbreviation
  • 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).
    Intervention: Behavioral: Behavioral Activation
  • 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.
    Intervention: Behavioral: Supportive Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
May 2014
May 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01179555
CURE-1837
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: Several manuscripts have been published.
Julia Haller, Wills Eye
Wills Eye
  • Thomas Jefferson University
  • Temple University
Principal Investigator: Julia Haller, MD Wills Eye
Study Director: Lisa Hark, PhD, RD Wills Eye
Wills Eye
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP