Lyme Disease Prevention Program

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Matthew H. Liang, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00000432
First received: January 18, 2000
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Lyme Disease
Tick-Borne Diseases
Behavioral: Education about disease prevention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention
Official Title: A Controlled Trial of a Primary and Secondary Program for Lyme Disease

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Estimated Enrollment: 20000
Study Start Date: April 1997
Study Completion Date: March 2001
Primary Completion Date: March 2001 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ferry passengers traveling to Nantucket Island

Exclusion Criteria:

  • Foreign (non-U.S.) residence
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000432

Locations
United States, Massachusetts
Steamship Authority ferry boats to Nantucket Island
Hyannis, Massachusetts, United States, 02601
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Matthew H. Liang, MD, MPH Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Matthew H. Liang, MD, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00000432     History of Changes
Other Study ID Numbers: P60 AR36308 NIAMS-017, P60AR036308
Study First Received: January 18, 2000
Last Updated: December 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Brigham and Women's Hospital:
Lyme disease
Education evaluation
Communicable disease control
Outcomes research
Tick-transmitted diseases

Additional relevant MeSH terms:
Lyme Disease
Tick-Borne Diseases
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Arbovirus Infections
Virus Diseases
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on September 30, 2014