A School-Based Intervention to Reduce Lyme Disease
Primary Purpose
Lyme Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Education
Control (pre and post surveys)
Sponsored by
About this trial
This is an interventional prevention trial for Lyme Disease focused on measuring Lyme disease, educational intervention for children, tick borne illness, prophylactic therapy in children, Self-efficacy, tick prevention, tick avoidance, health behavior modification
Eligibility Criteria
Inclusion:
- Child age 7-12 and their parents living in the selected endemic areas
Exclusion:
- No exclusions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Education
Control
Arm Description
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.
Students who fill out pre and post surveys and receive the intervention after the post-survey
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00594997
First Posted
January 7, 2008
Last Updated
March 11, 2021
Sponsor
Brigham and Women's Hospital
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00594997
Brief Title
A School-Based Intervention to Reduce Lyme Disease
Official Title
A School-Based Intervention to Reduce Lyme Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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:
The educational intervention will reduce the incidence of Lyme disease among children and families living in an endemic area.
The educational intervention will improve the childrens' self-confidence (behavioral self-efficacy), intention to perform, and actual practice of Lyme disease prevention behaviors.
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: 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Disease
Keywords
Lyme disease, educational intervention for children, tick borne illness, prophylactic therapy in children, Self-efficacy, tick prevention, tick avoidance, health behavior modification
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3570 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Students who fill out pre and post surveys and receive the intervention after the post-survey
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Students receive an educational intervention delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer
Intervention Type
Behavioral
Intervention Name(s)
Control (pre and post surveys)
Intervention Description
Students fill out a pre and post survey and then receive the same intervention given to the controls.
Primary Outcome Measure Information:
Title
The Incidence of Lyme Disease Among Children and Families Living in an Endemic Area Using an Educational Intervention
Description
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.
Time Frame
baseline - 1 year
Secondary Outcome Measure Information:
Title
The Educational Intervention Will Improve the Children's Self-confidence (Behavioral Self-efficacy), Intention to Perform, and Actual Practice of Lyme Disease Prevention Behaviors.
Description
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.
Time Frame
baseline -1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion:
Child age 7-12 and their parents living in the selected endemic areas
Exclusion:
No exclusions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy A Shadick, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
17468463
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. doi: 10.1177/1090198106294646. Epub 2007 Apr 27.
Results Reference
background
PubMed Identifier
17203005
Citation
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. doi: 10.1038/ncprheum0374.
Results Reference
background
PubMed Identifier
11275450
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. doi: 10.1016/s0749-3797(00)00315-9.
Results Reference
background
PubMed Identifier
11074914
Citation
Shadick NA, Lew RA, Liang MH. Outcomes of Lyme Disease. Ann Intern Med. 2000 Nov 7;133(9):746-747. doi: 10.7326/0003-4819-133-9-200011070-00023. No abstract available.
Results Reference
background
PubMed Identifier
9236962
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.
Results Reference
background
PubMed Identifier
27248436
Citation
Shadick NA, Zibit MJ, Nardone E, DeMaria A Jr, Iannaccone CK, Cui J. A School-Based Intervention to Increase Lyme Disease Preventive Measures Among Elementary School-Aged Children. Vector Borne Zoonotic Dis. 2016 Aug;16(8):507-15. doi: 10.1089/vbz.2016.1942. Epub 2016 Jun 1.
Results Reference
derived
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A School-Based Intervention to Reduce Lyme Disease
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