Back to resultsProject inCharge: Increasing the Rate of Comprehensive Eye Care Utilization by Older African Americans Through Community-Based Eye Health Education Program (inCharge)
Primary Purpose
Eye Disease, Eye Care, Vision
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eye care education
Social-contact control
Sponsored by
About this trial
This is an interventional prevention trial for Eye Disease
Eligibility Criteria
Inclusion Criteria:
- African Americans ages >=60 years residing in the communities targeted for intervention or control activities
Exclusion Criteria:
- Persons who do not speak English, persons who are not community-dwelling.
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
1
2
Arm Description
Educational intervention communicating practical information about vision, eye conditions and eye care.
Outcomes
Primary Outcome Measures
Change in the percentage of persons receiving comprehensive eye care from pre- to post- intervention
Secondary Outcome Measures
Improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care and reduction in perceived barriers to care.
Full Information
NCT ID
NCT00591110
First Posted
December 21, 2007
Last Updated
June 26, 2012
Sponsor
University of Alabama at Birmingham
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00591110
Brief Title
Project inCharge: Increasing the Rate of Comprehensive Eye Care Utilization by Older African Americans Through Community-Based Eye Health Education Program
Acronym
inCharge
Official Title
Project inCharge: Increasing the Rate of Comprehensive Eye Care Utilization by Older African Americans Through Community-Based Eye Health Education Program
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study design is a randomized intervention evaluation. Ten senior centers in predominately African American communities in the Birmingham, Alabama will be selected as sites for the educational intervention. Five centers will be randomly assigned to receive an educational intervention communicating practical information about vision, eye conditions and eye care as pertinent to the older African American population. The other five centers will serve as social-contact controls, where participants will receive an engaging information session on a non-health related topic. The primary outcome of interest is the change in percentage of persons receiving comprehensive eye care from pre- to post- intervention. The secondary outcomes are the process outcomes of improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Disease, Eye Care, Vision
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Educational intervention communicating practical information about vision, eye conditions and eye care.
Arm Title
2
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
Eye care education
Intervention Description
Participants will receive an educational intervention communicating practical information about vision, eye conditions and eye care pertinent to the older African American population
Intervention Type
Behavioral
Intervention Name(s)
Social-contact control
Intervention Description
Participants receive an engaging informational session on a non-health related topic
Primary Outcome Measure Information:
Title
Change in the percentage of persons receiving comprehensive eye care from pre- to post- intervention
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care and reduction in perceived barriers to care.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
African Americans ages >=60 years residing in the communities targeted for intervention or control activities
Exclusion Criteria:
Persons who do not speak English, persons who are not community-dwelling.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Owsley, PhD, MSPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23862298
Citation
Owsley C, McGwin G Jr, Searcey K, Weston J, Johnson A, Stalvey BT, Liu B, Girkin CA. Effect of an eye health education program on older African Americans' eye care utilization and attitudes about eye care. J Natl Med Assoc. 2013 Spring;105(1):69-76. doi: 10.1016/s0027-9684(15)30087-0.
Results Reference
derived
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Project inCharge: Increasing the Rate of Comprehensive Eye Care Utilization by Older African Americans Through Community-Based Eye Health Education Program
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