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Trial record 1 of 1 for:    NCT00591110
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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 (inCharge)

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ClinicalTrials.gov Identifier: NCT00591110
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : June 28, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Cynthia Owsley, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE December 21, 2007
First Posted Date  ICMJE January 11, 2008
Last Update Posted Date June 28, 2012
Study Start Date  ICMJE June 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2007)
Change in the percentage of persons receiving comprehensive eye care from pre- to post- intervention [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2007)
Improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care and reduction in perceived barriers to care. [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project inCharge: Increasing the Rate of Comprehensive Eye Care Utilization by Older African Americans Through Community-Based Eye Health Education Program
Official Title  ICMJE Project inCharge: Increasing the Rate of Comprehensive Eye Care Utilization by Older African Americans Through Community-Based Eye Health Education Program
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Eye Disease
  • Eye Care
  • Vision
Intervention  ICMJE
  • 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
  • Behavioral: Social-contact control
    Participants receive an engaging informational session on a non-health related topic
Study Arms  ICMJE
  • Active Comparator: 1
    Educational intervention communicating practical information about vision, eye conditions and eye care.
    Intervention: Behavioral: Eye care education
  • Sham Comparator: 2
    Intervention: Behavioral: Social-contact control
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2012)
177
Original Estimated Enrollment  ICMJE
 (submitted: December 31, 2007)
250
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00591110
Other Study ID Numbers  ICMJE X060908004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cynthia Owsley, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Cynthia Owsley, PhD, MSPH University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP