search
Back to results

Lyme Disease Prevention Program

Primary Purpose

Lyme Disease, Tick-Borne Diseases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Education about disease prevention
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lyme Disease focused on measuring Lyme disease, Education evaluation, Communicable disease control, Outcomes research, Tick-transmitted diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Ferry passengers traveling to Nantucket Island Exclusion Criteria: Foreign (non-U.S.) residence

Sites / Locations

  • Steamship Authority ferry boats to Nantucket Island

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 18, 2000
Last Updated
December 23, 2013
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Centers for Disease Control and Prevention
search

1. Study Identification

Unique Protocol Identification Number
NCT00000432
Brief Title
Lyme Disease Prevention Program
Official Title
A Controlled Trial of a Primary and Secondary Program for Lyme Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
March 2001 (Actual)
Study Completion Date
March 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Centers for Disease Control and Prevention

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Disease, Tick-Borne Diseases
Keywords
Lyme disease, Education evaluation, Communicable disease control, Outcomes research, Tick-transmitted diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Allocation
Randomized
Enrollment
20000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Education about disease prevention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ferry passengers traveling to Nantucket Island Exclusion Criteria: Foreign (non-U.S.) residence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew H. Liang, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steamship Authority ferry boats to Nantucket Island
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9236962
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.
Results Reference
background
PubMed Identifier
11275450
Citation
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. doi: 10.1016/s0749-3797(00)00315-9.
Results Reference
background

Learn more about this trial

Lyme Disease Prevention Program

We'll reach out to this number within 24 hrs