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Trial record 12 of 64 for:    lyme

A School-Based Intervention to Reduce Lyme Disease

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ClinicalTrials.gov Identifier: NCT00594997
Recruitment Status : Unknown
Verified July 2015 by Nancy Shadick, Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 16, 2008
Last Update Posted : July 31, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

January 7, 2008
January 16, 2008
July 31, 2015
April 2004
March 2008   (Final data collection date for primary outcome measure)
assess disease incidence in children by their answer to question number seventeen on the follow up questionnaire consistent with disease. [ Time Frame: by end of grant ]
Same as current
Complete list of historical versions of study NCT00594997 on ClinicalTrials.gov Archive Site
study self-efficacy for regular performance of the avoidance behaviors avoiding tick areas, wearing protective clothing, applying tick repellent to themselves and their pets and self-efficacy for regular tick checks. [ Time Frame: at end of grant ]
Same as current
Not Provided
Not Provided
 
A School-Based Intervention to Reduce Lyme Disease
A School-Based Intervention to Reduce Lyme Disease

Our overall goal is to develop, implement, evaluate and disseminate an effective and generalizable program to reduce Lyme disease in endemic areas through introducing a school-based intervention to children and families. We will:

1. Deliver an educational program in schools to promote personal protective practices, encourage early disease detection and modify residential habitats to reduce tick density.

3. Evaluate the program's efficacy by comparing the acceptability and practice of precautionary behavior, tick density in residential areas and rates of Lyme disease between groups using primary and surveillance data sources Evaluate the contribution of knowledge, attitudes, and parental involvement to children's adoption of prevention strategies.

4. Obtain data on the use of single dose tick bite prophylaxis in children and families.

5. Evaluate the cost of the intervention in relation to its impact on incidence of Lyme disease.

Hypothesis

The community intervention will reduce the incidence of Lyme disease among children and families living in endemic areas by increasing the practice of precautionary behavior and reducing tick density in residential areas. Specifically, we hypothesize that:

  1. The educational intervention will reduce the incidence of Lyme disease among children and families living in an endemic area.
  2. The educational intervention will improve the childrens' self-confidence (behavioral self-efficacy), intention to perform, and actual practice of Lyme disease prevention behaviors.

The description of Lyme disease in 1976 and subsequent characterization of its mode of transmission, causative organism and treatment is one of the most remarkable advances in medicine in the last 25 years1-3. Nevertheless, Lyme disease continues to grow as a public health problem4. While Lyme disease affects all age groups, children have one of the highest rates4. Prevention remains a challenge in this group. The Lyme vaccine has been withdrawn from the market in February 20025, 6, and educational strategies among at-risk school children have been inadequately evaluated and none have been institutionalized.

We will target school-aged children living in Nantucket, Dukes County and Essex County. We have collaborated with the teachers and administration in many of the schools. We have collaborated with the teachers and administration in many of the schools.

The intervention will be delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer ('Screaming with Pleasure Productions'). Research assistants will distribute the enrollment questionnaires and "goody" bags. The basic content of the educational message has been designed by Drs. Shadick, Liang, DeJong and the late Dr. Daltroy, and has been used extensively on the Nantucket ferry study and in the "Feel Find Free" Program. The timing takes advantage of the classroom audience, is humorous and entertaining and the message is relevant to anticipated outdoor activities.

Primary Outcome: Lyme disease. We will assess disease incidence in children by their answer to question number seventeen on the follow up questionnaire We will confirm our cases with medical record review from individuals reporting a tick-borne illness or symptoms consistent with disease. All non-respondents will be contacted up to 3 times, after which they will be considered lost to follow-up. We will also record any episodes of babesiosis, or ehrlichiosis. We will also track the rate of Lyme disease in the towns by passive surveillance from the Mass. Dept. of Public Health. Two independent clinicians blinded to group assignment will review charts.

Secondary Outcomes: Change in self-efficacy, behavioral intention, attitude and practice of health behaviors: We will study self-efficacy for regular performance of the avoidance behaviors avoiding tick areas, wearing protective clothing, applying tick repellent to themselves and their pets and self-efficacy for regular tick checks and recognizing early symptoms of Lyme disease on the children by the parents. We will study changes in baseline intention, perceived social support, attitudes and practice by children approximately one year after the education intervention. We hypothesize that the intervention will increase self-efficacy and intention to perform these behaviors. We will also assess practice of avoidance, tick checking and life style risk.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Lyme Disease
  • Behavioral: Education
    Students receive an educational intervention delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer
  • Behavioral: Control (pre and post surveys)
    Students fill out a pre and post survey and then receive the same intervention given to the controls.
  • Experimental: A
    Students who receive an educational intervention which consists of a 45 minute interactive presentation as well as a 30 minute health education entertainment by a juggler.
    Intervention: Behavioral: Education
  • Active Comparator: B
    Students who fill out pre and post surveys and receive the intervention after the post-survey
    Intervention: Behavioral: Control (pre and post surveys)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
4101
December 2015
March 2008   (Final data collection date for primary outcome measure)

Inclusion:

  • Child age 7-12 and their parents living in the selected endemic areas

Exclusion:

  • No exclusions
Sexes Eligible for Study: All
7 Years to 12 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00594997
2004P001033
5U01CI000164-04 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Nancy Shadick, Brigham and Women's Hospital
Brigham and Women's Hospital
Centers for Disease Control and Prevention
Principal Investigator: Nancy A Shadick, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
July 2015

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