Completed

A Controlled Trial of a Primary and Secondary Program for Lyme Disease

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What is being tested

Education about disease prevention

Behavioral
Who is being recruted

Vector Borne Diseases+6

+ Bacterial Infections and Mycoses

+ Bacterial Infections

+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: April 1997
See protocol details

Summary

Principal SponsorBrigham and Women's Hospital
Last updated: December 24, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00000432
Principal SponsorBrigham and Women's Hospital
Last updated: December 24, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Vector Borne DiseasesBacterial Infections and MycosesBacterial InfectionsBorrelia InfectionsInfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsLyme DiseaseTick-Borne Diseases

Criteria

1 inclusion criteria required to participate
Ferry passengers traveling to Nantucket Island

1 exclusion criteria prevent from participating
Foreign (non-U.S.) residence

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Steamship Authority ferry boats to Nantucket Island

Hyannis, United StatesOpen Steamship Authority ferry boats to Nantucket Island in Google Maps
CompletedOne Study Center