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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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 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 The Lyme vaccine has been withdrawn from the market in February 20025, 6, and educational strategies among at-risk school children have been inadequately evaluated and none have been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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education | Experimental | 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. |
|
| Control | Active Comparator | Students who fill out pre and post surveys and receive the intervention after the post-survey |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education | Behavioral | Students receive an educational intervention delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy A Shadick, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17468463 | Background | 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. | |
| 17203005 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Education | 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. 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 |
| FG001 | Control | Students who fill out pre and post surveys and receive the intervention after the post-survey Control (pre and post surveys): Students fill out a pre and post survey and then receive the same intervention given to the controls. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Education | 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. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of Lyme cases reported in the intervention and control groups | Posted | Number | Number of cases incident Lyme disease | baseline - 1 year |
|
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No adverse events were reported or observed for both the education and control groups
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Education | 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. 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 |
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Because all school districts were located in endemic areas for Lyme Disease, there was already a high level of awareness of Lyme Disease.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Shadick | Brigham and Women's Hospital | 617-732-5266 | nshadick@partners.org |
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| ID | Term |
|---|---|
| D008193 | Lyme Disease |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D007854 | Lead |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D019216 | Metals, Heavy |
| D004602 | Elements |
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| Control (pre and post surveys) | Behavioral | Students fill out a pre and post survey and then receive the same intervention given to the controls. |
|
| baseline -1 year |
| 11275450 | Background | 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. |
| 11074914 | Background | 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. |
| 9236962 | Background | 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. |
| 27248436 | Derived | 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. |
| BG001 |
| Control |
Students who fill out pre and post surveys and receive the intervention after the post-survey Control (pre and post surveys): Students fill out a pre and post survey and then receive the same intervention given to the controls. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Grade | Number | participants |
|
| OG001 | Control | The number of incident cases of Lyme reported by parents of students in the control group. These students did not receive the educational intervention. |
|
|
| 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. | Composite knowledge score for intervention and control students post-intervention. Comparing the change in score between intervention and controls between pre and post evaluation. | Posted | Mean | Standard Deviation | units on a scale | baseline -1 year |
|
|
|
|
| 0 |
| 1,562 |
| 0 |
| 1,562 |
| 0 |
| 1,562 |
| EG001 | Control | Students who fill out pre and post surveys and receive the intervention after the post-survey Control (pre and post surveys): Students fill out a pre and post survey and then receive the same intervention given to the controls. | 0 | 2,008 | 0 | 2,008 | 0 | 2,008 |
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| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007287 |
| Inorganic Chemicals |
| D008670 | Metals |