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Confronting Unequal Eye Care in Pennsylvania

Primary Purpose

Diabetic Retinopathy, Diabetes Mellitus, Type 2, Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation
Supportive Therapy
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Retinopathy focused on measuring 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

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Thomas Jefferson University
  • Wills Eye Health System
  • Temple University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pt. 1 Behavioral Activation

Pt. 1 Supportive Therapy

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Pt. 1 Diabetes self-care behaviors
Yields a global scale that summarizes self-care behaviors
Pt. 1 Depressive Symptoms
Patient Health Questionnaire-9 (PHQ-9)
Pt. 2 Appointment Adherence Characteristics
To assess the relationship between appointment adherence and particular demographic characteristics, clinical factors, and systems-level variables.

Full Information

First Posted
August 10, 2010
Last Updated
April 6, 2017
Sponsor
Wills Eye
Collaborators
Thomas Jefferson University, Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT01179555
Brief Title
Confronting Unequal Eye Care in Pennsylvania
Official Title
Confronting Unequal Eye Care in Pennsylvania
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
Thomas Jefferson University, Temple University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Diabetes Mellitus, Type 2, Glaucoma
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pt. 1 Behavioral Activation
Arm Type
Experimental
Arm Description
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).
Arm Title
Pt. 1 Supportive Therapy
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Other Intervention Name(s)
BA - abbreviation
Intervention Description
Baseline assessment plus 4 in-home problem solving therapy sessions.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Therapy
Other Intervention Name(s)
ST-abbreviation
Intervention Description
Baseline assessment plus 4 in-home sessions of supportive therapy.
Primary Outcome Measure Information:
Title
Pt. 1 Dilated Fundus Exam (DFE)
Description
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
Time Frame
6-month follow-up assessment
Secondary Outcome Measure Information:
Title
Pt. 1 Risk perceptions of diabetes
Description
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
Time Frame
6-month follow up assessment
Title
Pt. 1 Diabetes self-care behaviors
Description
Yields a global scale that summarizes self-care behaviors
Time Frame
6-month follow up assessment
Title
Pt. 1 Depressive Symptoms
Description
Patient Health Questionnaire-9 (PHQ-9)
Time Frame
6-month follow up assessment
Title
Pt. 2 Appointment Adherence Characteristics
Description
To assess the relationship between appointment adherence and particular demographic characteristics, clinical factors, and systems-level variables.
Time Frame
Dependent on Diagnosis
Other Pre-specified Outcome Measures:
Title
Pt. 2 Cost-effectiveness
Description
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.
Time Frame
Conclusion of Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Haller, MD
Organizational Affiliation
Wills Eye
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Hark, PhD, RD
Organizational Affiliation
Wills Eye
Official's Role
Study Director
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Wills Eye Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Several manuscripts have been published.
Citations:
PubMed Identifier
26068230
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.
Results Reference
background
PubMed Identifier
27269487
Citation
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.
Results Reference
background
PubMed Identifier
26924099
Citation
Pizzi LT, Tran J, Shafa A, Waisbourd M, Hark L, Murchison AP, Dai Y, Mayro EL, Haller JA. Effectiveness and Cost of a Personalized Reminder Intervention to Improve Adherence to Glaucoma Care. Appl Health Econ Health Policy. 2016 Apr;14(2):229-40. doi: 10.1007/s40258-016-0231-8.
Results Reference
derived

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Confronting Unequal Eye Care in Pennsylvania

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