NCT00591110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2007

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

9 months

First QC Date

December 21, 2007

Last Update Submit

June 26, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in the percentage of persons receiving comprehensive eye care from pre- to post- intervention

    6 months

Secondary Outcomes (1)

  • Improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care and reduction in perceived barriers to care.

    18 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

Behavioral: Eye care education

2

SHAM COMPARATOR
Behavioral: Social-contact control

Interventions

Participants will receive an educational intervention communicating practical information about vision, eye conditions and eye care pertinent to the older African American population

1

Participants receive an engaging informational session on a non-health related topic

2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African Americans ages \>=60 years residing in the communities targeted for intervention or control activities

You may not qualify if:

  • Persons who do not speak English, persons who are not community-dwelling.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Eye Diseases

Study Officials

  • Cynthia Owsley, PhD, MSPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nathan E. Miles Chair of Ophthalmology, Vice Chair for Clinical Research

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 11, 2008

Study Start

June 1, 2008

Primary Completion

March 1, 2009

Study Completion

December 1, 2009

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations