A School-Based Intervention to Reduce Lyme Disease

Lyme Disease Clinical Trial

Official title:

A School-Based Intervention to Reduce Lyme Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594997
• Other study ID #: 2004P001033
• Status: Completed
• Phase: N/A
• Start date: April 2004
• Est. completion date: August 2016

Study information

• Verified date: March 2021
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our overall purpose of this study is evaluate whether a short in-class Lyme Disease education program based on social learning theory and the Health Belief Model can impact a child's knowledge, attitude, and preventive behavior.

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.

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.

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 The Lyme vaccine has been withdrawn from the market in February 20025, 6, and educational strategies among at-risk school children have been inadequately evaluated and none have been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: The educational intervention will reduce the incidence of Lyme Disease among children and families living in an endemic area.

Secondary Outcomes: The educational intervention will improve the children's self-confidence (behavioral self-efficacy), intention to perform, and actual practice of Lyme disease prevention behaviors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3570
• Est. completion date: August 2016
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion:

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

Exclusion:

• No exclusions

Related Conditions & MeSH terms

• Lyme Disease

Intervention

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
• Control (pre and post surveys)
Students fill out a pre and post survey and then receive the same intervention given to the controls.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Centers for Disease Control and Prevention

References & Publications (5)

Corapi KM, White MI, Phillips CB, Daltroy LH, Shadick NA, Liang MH. Strategies for primary and secondary prevention of Lyme disease. Nat Clin Pract Rheumatol. 2007 Jan;3(1):20-5. Review. — View Citation

Daltroy LH, Phillips C, Lew R, Wright E, Shadick NA, Liang MH. A controlled trial of a novel primary prevention program for Lyme disease and other tick-borne illnesses. Health Educ Behav. 2007 Jun;34(3):531-42. Epub 2007 Apr 27. — View 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. — View 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. — View Citation

Shadick NA, Lew RA, Liang MH. Outcomes of Lyme Disease. Ann Intern Med. 2000 Nov 7;133(9):746-747. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Incidence of Lyme Disease Among Children and Families Living in an Endemic Area Using an Educational Intervention	Parents of children were asked at baseline to report any new case of Lyme Disease within the past 12 months. This question was asked again a year later after receiving the educational intervention was given. We then will compare the number of reported Lyme Disease cases at baseline to the number of Lyme disease cases reported a year later. New cases of Lyme Disease had to be confirmed by medical record review.	baseline - 1 year
Secondary	The Educational Intervention Will Improve the Children's Self-confidence (Behavioral Self-efficacy), Intention to Perform, and Actual Practice of Lyme Disease Prevention Behaviors.	Three outcome measures, knowledge of LD transmission, self reported tick bite precautionary behaviors and attitudes towards taking precautions were measured. A Lyme Disease knowledge score was created from totaling the number of correct answers on the 6 knowledge questions, ranging from 0-6. A score with a higher value indicated an increase in the desired behavior. These questions were asked before and after the intervention to compared the change from preintervention with postintervention between intervention and control students, adjusted for age, sex and pre-knowledge score. Precautionary behavior outcomes were graded on a linear scale quantifying the amount of practice.	baseline -1 year