NCT00649766

Brief Summary

The purpose of this project is to test two different types of health messages, one that is developed for a specific group (targeted) and the other that is more personalized to individuals (tailored), to see which is better at changing how often people have their eyes examined. We hypothesize that people who get the tailored messages will be more likely to get a dilated eye exam than people who receive the targeted messages.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2008

Enrollment Period

1.9 years

First QC Date

March 28, 2008

Last Update Submit

March 28, 2008

Conditions

Keywords

tailored health messagesglaucomadiabetic retinopathydilated fundus examshealth behavior

Outcome Measures

Primary Outcomes (1)

  • doctor-confirmed dilated eye examination

    3 and 6 months

Study Arms (2)

1

ACTIVE COMPARATOR

tailored print messages to encourage eye examination behavior

Behavioral: tailored newsletter

2

ACTIVE COMPARATOR

targeted print messages to encourage eye examination behavior

Behavioral: targeted newsletter

Interventions

Tailored newsletter that addresses each person's stage of change, barriers to getting eye exams, and knowledge of eye exams and eye disease

1

Targeted newsletter that contains messages about barriers to getting eye exams and presents facts about glaucoma and African-Americans.

2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • African-American
  • years of age or older
  • no dilated fundus exam in past 2 years

You may not qualify if:

  • appointment for dilated fundus exam scheduled
  • no access to phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

  • Ellish NJ, Royak-Schaler R, Passmore SR, Higginbotham EJ. Knowledge, attitudes, and beliefs about dilated eye examinations among African-Americans. Invest Ophthalmol Vis Sci. 2007 May;48(5):1989-94. doi: 10.1167/iovs.06-0934.

  • Ellish NJ, Royak-Schaler R, Higginbotham EJ. Tailored and targeted interventions to encourage dilated fundus examinations in older African Americans. Arch Ophthalmol. 2011 Dec;129(12):1592-8. doi: 10.1001/archophthalmol.2011.190.

MeSH Terms

Conditions

Eye DiseasesGlaucomaDiabetic RetinopathyHealth Behavior

Condition Hierarchy (Ancestors)

Ocular HypertensionRetinal DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesBehavior

Study Officials

  • Nancy J. Ellish, DrPH, MSPH

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 1, 2008

Study Start

June 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

April 1, 2008

Record last verified: 2008-03

Locations