Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000432
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2000-01-18
Brief Title:
Lyme Disease Prevention Program
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
A Controlled Trial of a Primary and Secondary Program for Lyme Disease
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons 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 residentvisitor 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 MD 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
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 residentvisitor 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 MD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P60AR036308 | NIH | None | httpsreporternihgovquickSearchP60AR036308 |