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Trial record 19 of 64 for:    lyme

Lyme Disease Prevention Program

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ClinicalTrials.gov Identifier: NCT00000432
Recruitment Status : Completed
First Posted : January 19, 2000
Last Update Posted : December 24, 2013
Information provided by (Responsible Party):

January 18, 2000
January 19, 2000
December 24, 2013
April 1997
March 2001   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00000432 on ClinicalTrials.gov Archive Site
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Lyme Disease Prevention Program
A Controlled Trial of a Primary and Secondary Program for Lyme Disease
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.

This is a large, randomized trial of a Lyme disease primary prevention program for passengers on ferry boats going to Nantucket Island for the period from Memorial Day until Labor Day. Boats are randomized to experimental or control interventions.

The experimental intervention is a performance-based educational program on Lyme disease prevention, and uses supplemental materials. An entertainment troupe delivers the intervention using comedy, theater, and vaudevillian techniques. The entertainers present three shows in different locations on the boat. Each show is about 10 minutes and covers the severity and likelihood of acquiring Lyme disease and the benefits of tick avoidance and search and removal behaviors. When people on experimental boats enroll in the study they receive the following free materials: a wallet-sized tick ID card, a laminated shower card with tick-removal instructions, a map showing tick habitats, a tick-feeling card, and an educational pamphlet. Control boats do not have performers. Participants on control boats receive education on road safety and injury prevention from rollerblade, bicycle, and skateboard accidents.

We will collect baseline data at enrollment, including name, address, demographics, resident/visitor status, length of stay on island, frequency of exposure to tick areas, history of tick-transmitted disease, and exposure to intervention. We will enroll a random subsample of participants in a study of behavior, and will ask them additional questions on self-efficacy, intention to perform prevention behaviors and attitude about or social support for practicing prevention behaviors while on the island.

We will follow people in the behavioral subsample at 1 week to find out their actual behaviors. We will follow all subjects at 2 months to find out self-reported disease status. We ask persons reporting a visit to an M.D. for illness to mail a form to their physician for confirmation of diagnosis and to provide information about health-care use. The main outcome is Lyme disease. Intermediate outcomes include change in self-efficacy, behavioral intention, and health behaviors.

Phase 3
Allocation: Randomized
Primary Purpose: Prevention
  • Lyme Disease
  • Tick-Borne Diseases
Behavioral: Education about disease prevention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2001
March 2001   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ferry passengers traveling to Nantucket Island

Exclusion Criteria:

  • Foreign (non-U.S.) residence
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
P60 AR36308 NIAMS-017
P60AR036308 ( U.S. NIH Grant/Contract )
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Matthew H. Liang, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Centers for Disease Control and Prevention
Principal Investigator: Matthew H. Liang, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
December 2013

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