Confronting Unequal Eye Care in Pennsylvania

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Confronting Unequal Eye Care in Pennsylvania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179555
• Other study ID #: CURE-1837
• Status: Completed
• Phase: N/A
• First received: August 10, 2010
• Last updated: April 6, 2017
• Start date: October 2010
• Est. completion date: May 2014

Study information

• Verified date: April 2017
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Retinopathy
• Glaucoma

Intervention

Behavioral:
• Behavioral Activation
Baseline assessment plus 4 in-home problem solving therapy sessions.
• Supportive Therapy
Baseline assessment plus 4 in-home sessions of supportive therapy.

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Wills Eye Health System	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Wills Eye	Temple University, Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Rovner BW, Haller JA, Casten RJ, Murchison AP, Hark LA. Cultural and Cognitive Determinants of Personal Control in Older African Americans with Diabetes. J Natl Med Assoc. 2015 Jun;107(2):25-31. doi: 10.1016/S0027-9684(15)30021-3. Epub 2015 Dec 2. — View Citation

Weiss DM, Casten RJ, Leiby BE, Hark LA, Murchison AP, Johnson D, Stratford S, Henderer J, Rovner BW, Haller JA. Effect of Behavioral Intervention on Dilated Fundus Examination Rates in Older African American Individuals With Diabetes Mellitus: A Randomized Clinical Trial. JAMA Ophthalmol. 2015 Sep;133(9):1005-12. doi: 10.1001/jamaophthalmol.2015.1760. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pt. 2 Cost-effectiveness	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.	Conclusion of Study
Primary	Pt. 1 Dilated Fundus Exam (DFE)	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	6-month follow-up assessment
Secondary	Pt. 1 Risk perceptions of diabetes	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	6-month follow up assessment
Secondary	Pt. 1 Diabetes self-care behaviors	Yields a global scale that summarizes self-care behaviors	6-month follow up assessment
Secondary	Pt. 1 Depressive Symptoms	Patient Health Questionnaire-9 (PHQ-9)	6-month follow up assessment
Secondary	Pt. 2 Appointment Adherence Characteristics	To assess the relationship between appointment adherence and particular demographic characteristics, clinical factors, and systems-level variables.	Dependent on Diagnosis