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
|Condition or disease||Intervention/treatment||Phase|
|Lyme Disease Tick-Borne Diseases||Behavioral: Education about disease prevention||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||20000 participants|
|Official Title:||A Controlled Trial of a Primary and Secondary Program for Lyme Disease|
|Study Start Date :||April 1997|
|Actual Primary Completion Date :||March 2001|
|Actual Study Completion Date :||March 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000432
|United States, Massachusetts|
|Steamship Authority ferry boats to Nantucket Island|
|Hyannis, Massachusetts, United States, 02601|
|Principal Investigator:||Matthew H. Liang, MD, MPH||Brigham and Women's Hospital|