Confronting Unequal Eye Care in Pennsylvania

This study is ongoing, but not recruiting participants.
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: November 26, 2013
Last verified: November 2013
  Purpose

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 Intervention
Diabetic Retinopathy
Diabetes Mellitus, Type 2
Behavioral: Behavioral Activation
Behavioral: Supportive Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Confronting Unequal Eye Care in Pennsylvania

Resource links provided by NLM:


Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Dilated Fundus Exam (DFE) [ Time Frame: 6-month follow up assessment ] [ Designated as safety issue: No ]
    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:
  • Risk perceptions of diabetes [ Time Frame: 6-month follow up assessment ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Yields a global scale that summarizes self-care behaviors

  • Depressive Symptoms [ Time Frame: 6-month follow up assessment ] [ Designated as safety issue: No ]
    Patient Health Questionnaire-9 (PHQ-9)


Estimated Enrollment: 206
Study Start Date: October 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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). With the subject's approval, the CHE will include a family member or friend, if available, to enable him or her to encourage the subject to follow the plan.
Behavioral: Behavioral Activation
Baseline assessment plus 4 in-home problem solving therapy sessions.
Other Name: BA - abbreviation
Placebo Comparator: 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. ST is meant to function as our control group. Its effects are transient and not associated with meaningful improvement in health behaviors.
Behavioral: Supportive Therapy
Baseline assessment plus 4 in-home sessions of supportive therapy.
Other Name: ST-abbreviation

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179555

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

No publications provided

Responsible Party: Julia Haller, Ophthalmologist-in-Chief, Wills Eye
ClinicalTrials.gov Identifier: NCT01179555     History of Changes
Other Study ID Numbers: CURE-1837
Study First Received: August 10, 2010
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wills Eye:
Diabetic Complications
Intervention Studies
African Americans
Vision Screening
Vision, Low
Geriatric Assessment
Outcomes Assessment
Cultural Characteristics
Cultural Competency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on September 30, 2014