Clincosm LogoSign in Get a demo

Project inCharge: Increasing the Rate of Comprehensive Eye Care Utilization by Older African Americans Through Community-Based Eye Health Education Program

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT00591110
Collaborator
Pfizer (Industry)
177
Enrollment
1
Location
2
Arms
18
Duration (Months)
9.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Eye care education
  • Behavioral: Social-contact control
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
177 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Project inCharge: Increasing the Rate of Comprehensive Eye Care Utilization by Older African Americans Through Community-Based Eye Health Education Program
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Educational intervention communicating practical information about vision, eye conditions and eye care.

Behavioral: Eye care education
Participants will receive an educational intervention communicating practical information about vision, eye conditions and eye care pertinent to the older African American population
Sham Comparator: 2

Behavioral: Social-contact control
Participants receive an engaging informational session on a non-health related topic

Outcome Measures

Primary Outcome Measures

  1. Change in the percentage of persons receiving comprehensive eye care from pre- to post- intervention [6 months]

Secondary Outcome Measures

  1. Improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care and reduction in perceived barriers to care. [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294

Sponsors and Collaborators

  • University of Alabama at Birmingham
  • Pfizer

Investigators

  • Principal Investigator: Cynthia Owsley, PhD, MSPH, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cynthia Owsley, Nathan E. Miles Chair of Ophthalmology, Vice Chair for Clinical Research, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00591110
Other Study ID Numbers:
  • X060908004
First Posted:
Jan 11, 2008
Last Update Posted:
Jun 28, 2012
Last Verified:
Jun 1, 2012
Additional relevant MeSH terms:
Eye Diseases

Study Results

No Results Posted as of Jun 28, 2012