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Trial record 2 of 76 for:    lyme AND Diseases

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
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Matthew H. Liang, MD, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE January 18, 2000
First Posted Date  ICMJE January 19, 2000
Last Update Posted Date December 24, 2013
Study Start Date  ICMJE April 1997
Actual Primary Completion Date March 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00000432 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Lyme Disease Prevention Program
Official Title  ICMJE A Controlled Trial of a Primary and Secondary Program for Lyme Disease
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.

Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Prevention
Condition  ICMJE
  • Lyme Disease
  • Tick-Borne Diseases
Intervention  ICMJE Behavioral: Education about disease prevention
Study Arms Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
20000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date March 2001
Actual Primary Completion Date March 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ferry passengers traveling to Nantucket Island

Exclusion Criteria:

  • Foreign (non-U.S.) residence
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000432
Other Study ID Numbers  ICMJE P60 AR36308 NIAMS-017
P60AR036308 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Matthew H. Liang, MD, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Matthew H. Liang, MD, MPH Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP