Diabetes Mellitus, Type 2, Diabetic Retinopathy, Glaucoma
Conditions
Keywords
Diabetic Complications, Intervention Studies, African Americans, Vision Screening, Vision, Low, Geriatric Assessment, Outcomes Assessment, Cultural Characteristics, Cultural Competency, Appointment Adherence, Cost-effectiveness, Personalization of care, Follow-up Care
Brief 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.
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. 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.
Interventions
BEHAVIORALBehavioral Activation
Baseline assessment plus 4 in-home problem solving therapy sessions.
BEHAVIORALSupportive Therapy
Baseline assessment plus 4 in-home sessions of supportive therapy.
Sponsors
Thomas Jefferson University
Temple University
Wills Eye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pt. 1 Dilated Fundus Exam (DFE) | 6-month follow-up assessment | 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
| Measure | Time frame | Description |
|---|---|---|
| Pt. 1 Risk perceptions of diabetes | 6-month follow up assessment | 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 |
| Pt. 1 Diabetes self-care behaviors | 6-month follow up assessment | Yields a global scale that summarizes self-care behaviors |
| Pt. 1 Depressive Symptoms | 6-month follow up assessment | Patient Health Questionnaire-9 (PHQ-9) |
| Pt. 2 Appointment Adherence Characteristics | Dependent on Diagnosis | To assess the relationship between appointment adherence and particular demographic characteristics, clinical factors, and systems-level variables. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pt. 2 Cost-effectiveness | Conclusion of Study | 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. |
Countries
United States
Outcome results
None listed