Lyme Disease Prevention Program

Lyme Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000432
• Other study ID #: P60 AR36308 NIAMS-017
• Secondary ID: P60AR036308
• Status: Completed
• Phase: Phase 3
• First received: January 18, 2000
• Last updated: December 23, 2013
• Start date: April 1997
• Est. completion date: March 2001

Study information

• Verified date: December 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20000
• Est. completion date: March 2001
• Est. primary completion date: March 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Ferry passengers traveling to Nantucket Island

Exclusion Criteria:

• Foreign (non-U.S.) residence

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lyme Disease
• Tick-Borne Diseases

Intervention

Behavioral:
• Education about disease prevention

Locations

Country	Name	City	State
United States	Steamship Authority ferry boats to Nantucket Island	Hyannis	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Centers for Disease Control and Prevention, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation