This trial is active, not recruiting.

Conditions diabetic retinopathy, diabetes mellitus, type 2
Treatments behavioral activation, supportive therapy
Sponsor Wills Eye
Collaborator Thomas Jefferson University
Start date October 2010
End date May 2014
Trial size 206 participants
Trial identifier NCT01179555, CURE-1837


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
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 activation BA - abbreviation
Baseline assessment plus 4 in-home problem solving therapy sessions.
(Placebo Comparator)
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.
supportive therapy ST-abbreviation
Baseline assessment plus 4 in-home sessions of supportive therapy.

Primary Outcomes

Dilated Fundus Exam (DFE)
time frame: 6-month follow up assessment

Secondary Outcomes

Risk perceptions of diabetes
time frame: 6-month follow up assessment
Diabetes self-care behaviors
time frame: 6-month follow up assessment
Depressive Symptoms
time frame: 6-month follow up assessment

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title Confronting Unequal Eye Care in Pennsylvania
Principal investigator Julia Haller, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Wills Eye.