Confronting Unequal Eye Care in Pennsylvania - Full Text View

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:

MedlinePlus related topics: Diabetes Diabetes Complications Diabetes Type 2 Diabetic Eye Problems Retinal Disorders

U.S. FDA Resources

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:	October 2012 (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

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

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

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

Contacts

Contact: David Weiss, BA	267-285-7659	dweiss@willseye.org
Contact: Lisa Hark, PhD, RD	215-928-3045	lhark@willseye.org

Locations

United States, Pennsylvania
Wills Eye Health System	Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
Temple University	Recruiting
Philadelphia, Pennsylvania, United States, 19140
Principal Investigator: Jeffrey Henderer, MD
Thomas Jefferson University	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Barry Rovner, MD
Sub-Investigator: Robin Casten, PhD

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:	August 20, 2012
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 Complications
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Retinopathy
Retinal Diseases
Glucose Metabolism Disorders

Metabolic Diseases
Endocrine System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013