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

August 10, 2010
November 26, 2013
October 2010
May 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01179555 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Confronting Unequal Eye Care in Pennsylvania
Confronting Unequal Eye Care in Pennsylvania

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Diabetic Retinopathy
  • Diabetes Mellitus, Type 2
  • 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: 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.
    Intervention: Behavioral: Behavioral Activation
  • 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.
    Intervention: Behavioral: Supportive Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
206
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01179555
CURE-1837
Yes
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
November 2013

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