A School-Based Intervention to Reduce Lyme Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nancy Shadick, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00594997
First received: January 7, 2008
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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.

Condition Intervention
Lyme Disease
Behavioral: Education
Behavioral: Control (pre and post surveys)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A School-Based Intervention to Reduce Lyme Disease

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 4101
Study Start Date: April 2004
Estimated Study Completion Date: December 2014
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Active Comparator: B
Students who fill out pre and post surveys and receive the intervention after the post-survey
Behavioral: Control (pre and post surveys)
Students fill out a pre and post survey and then receive the same intervention given to the controls.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

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

Exclusion:

  • No exclusions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594997

Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Nancy A Shadick, MD, MPH Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Nancy Shadick, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00594997     History of Changes
Other Study ID Numbers: 2004P001033, 5U01CI000164-04
Study First Received: January 7, 2008
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Lyme disease
educational intervention for children
tick borne illness
prophylactic therapy in children
Self-efficacy
tick prevention
tick avoidance
health behavior modification

Additional relevant MeSH terms:
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections

ClinicalTrials.gov processed this record on April 17, 2014