NCT00000432

Brief Summary

This is a large study of an educational program on Lyme disease prevention for passengers on ferry boats going to Nantucket Island during the period from Memorial Day until Labor Day. Some boats provide passengers with the experimental program and the other boats provide a "control" program that the researchers can compare to the experimental program. The experimental program uses live performances by entertainers to teach people about Lyme disease prevention, and also uses additional printed materials. People on the control boats receive education on injury prevention and road safety while bicycling, rollerblading, and using mopeds. The main result we will look for is Lyme disease identified by a followup survey and confirmed by reviewing medical records. We will also ask some people to take part in a smaller study of behavior change. In this study, we will ask people to complete forms on self-efficacy (a person's belief in his or her ability to reach a certain goal), their plans to take preventive steps, and actual prevention behaviors. We also ask participants who report doctor visits or illness to provide confirmation of their use of health services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 1997

Typical duration for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2000

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
Last Updated

December 24, 2013

Status Verified

December 1, 2013

Enrollment Period

3.9 years

First QC Date

January 18, 2000

Last Update Submit

December 23, 2013

Conditions

Keywords

Lyme diseaseEducation evaluationCommunicable disease controlOutcomes researchTick-transmitted diseases

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Ferry passengers traveling to Nantucket Island

You may not qualify if:

  • Foreign (non-U.S.) residence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steamship Authority ferry boats to Nantucket Island

Hyannis, Massachusetts, 02601, United States

Location

Related Publications (2)

  • Shadick NA, Daltroy LH, Phillips CB, Liang US, Liang MH. Determinants of tick-avoidance behaviors in an endemic area for Lyme disease. Am J Prev Med. 1997 Jul-Aug;13(4):265-70.

    PMID: 9236962BACKGROUND
  • Phillips CB, Liang MH, Sangha O, Wright EA, Fossel AH, Lew RA, Fossel KK, Shadick NA. Lyme disease and preventive behaviors in residents of Nantucket Island, Massachusetts. Am J Prev Med. 2001 Apr;20(3):219-24. doi: 10.1016/s0749-3797(00)00315-9.

    PMID: 11275450BACKGROUND

MeSH Terms

Conditions

Lyme DiseaseTick-Borne Diseases

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBorrelia InfectionsSpirochaetales InfectionsVector Borne Diseases

Study Officials

  • Matthew H. Liang, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 18, 2000

First Posted

January 19, 2000

Study Start

April 1, 1997

Primary Completion

March 1, 2001

Study Completion

March 1, 2001

Last Updated

December 24, 2013

Record last verified: 2013-12

Locations