Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144443
Status:
TERMINATED
Last Update Posted:
2021-01-20
First Post:
2005-09-02
Brief Title:
Kansas City Community Environmental Remediation And Training KC CERT
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Kansas City Community Environmental Remediation And Training KC CERT
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective Our overall objective is to test the hypothesis that the health of children with chronic respiratory symptoms or chronic exposures to environmental hazards can be improved through a combination of standard home maintenance interventions and a set of interim controls and targeted repair interventions
I Background
The Bi-State Kansas City Enhanced Enterprise Community KCEEC is one of pervasive poverty unemployment and general distress This same area is also an area of poor environmental health with a disproportionate number of children with lead poisoning asthma and home injuries
In May 2001 the Metropolitan Kansas City Health Council released a report urging the implementation of strategies to address this growing concern They stated Environmental assessments and interventions in homes schools and workplaces are needed to promote indoor air quality and thereby help prevent asthma and asthma flare-ups in combination with the need for trained community-based peer educators needed to work with familiescommunities in areas of high asthma incidence The need for major rehabilitation is echoed in the 1999 Consolidated Plan as well as by most community development and housing officials
The KC CERT project responds to these concerns by demonstrating low-cost replicable intervention strategies that can have an impact on the health and safety of children and their families By providing training and employment opportunities to residents in high-risk areas to assess prevent and remediate environmental hazards this project promotes sustained systematic change within the KCEEC
I Background
The Bi-State Kansas City Enhanced Enterprise Community KCEEC is one of pervasive poverty unemployment and general distress This same area is also an area of poor environmental health with a disproportionate number of children with lead poisoning asthma and home injuries
In May 2001 the Metropolitan Kansas City Health Council released a report urging the implementation of strategies to address this growing concern They stated Environmental assessments and interventions in homes schools and workplaces are needed to promote indoor air quality and thereby help prevent asthma and asthma flare-ups in combination with the need for trained community-based peer educators needed to work with familiescommunities in areas of high asthma incidence The need for major rehabilitation is echoed in the 1999 Consolidated Plan as well as by most community development and housing officials
The KC CERT project responds to these concerns by demonstrating low-cost replicable intervention strategies that can have an impact on the health and safety of children and their families By providing training and employment opportunities to residents in high-risk areas to assess prevent and remediate environmental hazards this project promotes sustained systematic change within the KCEEC
Detailed Description:
This study is an observational study It will be managed by a project director for HHN and the Environmental Health Program Manager for CMH Following enrollment in the study a health assessment focusing on specific respiratory problems and lead exposure will be performed Eligible subjects must be between the ages of 2 and 17 years of age and stay in the home a minimum of 4 nights per week
The home environment will also be assessed using a specific set of on-site and laboratory sampling and analyses Once study analyses are complete a report will be written and provided to the family The health and home assessments will be used in the presentation of in-home education related to specific strategies for creating and maintaining a safe and healthy home Once the initial assessments are complete the family will receive a set of standard and targeted interventions that together total no more than 2000 in value If the house is in need of more than 2000 worth of interventions the family would not qualify to participate in this study and would be offered alternative resources through the HHN and the UMKC Center for the City Home Center
The interim controls recommended in the assessment will be provided within 60 days of the in-home education These interim controls include a set of standard interventions that will be provided in all homes and in addition a set of site-specific or targeted interventions based on the assessment findings Six months after the interventions have been implemented the childs health and the home will be assessed using the same instruments procedures questionnaires and the same number and type of samples as in the initial assessment will be taken This will ensure consistency and quality in data gathering
Recruitment of Subjects
The Healthy Homes Network will recruit participants from community physicians and clinics and organizations affiliated with the HHN including health departments and housing authorities the CMH Emergency Room the CMH Allergy Clinic other CMH primary care clinics HHN will recruit through advertising in the media if necessary see proposed ad included but the CMH name or LOGO will not appear in the ad Subjects will be referred to CMH for health evaluations
Expected Sample Size Total study 200 CMH only 200
Inclusion Criteria
Participants that qualify for the study will have one of the following health conditions persistent asthma as defined by NHLBI guidelines chronic respiratory symptoms andor have lead levels equal to or above 15 micrograms per deciliter They must be between the ages of 2 and 17 years of age and stay in the home a minimum of 4 nights per week and they should reside in the KCEEC Defined as the city limits of Kansas City Kansas or Kansas City Missouri They will also have lived in the same housing either rental or self-owned for at least 6 months and have a reasonable expectation of remaining in this housing for at least one additional year
To qualify for the intervention phase of the study done by HHN the home must have no more than 2000 estimated intervention costs Examples of houses that would not qualify include A house that needs a new roof a house with extensive amounts of flaking lead paint a house with significant structural problems
Exclusion Criteria
Any children who do not meet the age and residency requirements Any home with more than 2000 worth of maintenance and repair problems Any home with emergent life threatening conditions Children with other chronic diseases leukemia diabetes etc will be referred through the HHN and CMH to appropriate medical services agencies organizations and other community resources
There is only one study group the immediate intervention group In this group the childs health will be evaluated the home environmental health will be assessed and reported to the family and the family will receive in-home education Within 60 days of the in-home education a series of interim controls for the home will be provided by HHN using a specific set of standard interventions and a site-specific set of targeted interventions based on the assessment findings The home will be checked to ensure the interventions were properly done After 6 months the childs health will be reevaluated and the environmental health of the home will be assessed a second time to evaluate the impact on the childs health
ObservationsMeasurements
Goal 1 Demonstrate improvement in overall health and chronic symptoms in children
PrePost Measures
1 Health Assessment Questionnaire
2 Asthma severity assigned by blinded physician - based on health assessment and spirometry for children 5 years old
3 Medication dosage taken from family health information
4 Blood lead level measured in clinical lab
5 Allergen Specific IgG IgE measured in clinical lab
6 Number of days of school missed taken from family health survey
7 Number of days as in-patient in hospital taken from hospital records
8 Number of visits to physicianER taken from clinic records
9 Quality of life rating from SF12 form
10 Asthma specific quality of life rating Juniper et al
Goal 2 Reduce specific environmental hazards potentially affecting health through interventions
PrePost Measures
1 IAQ Survey On-site analyses for Temp RH CO2 CO THC VOC TVOC
2 Allergen content in house dust lab measurement by immunoassay
3 Total Particulate Analysis on-site laser particle analysis
4 Airborne spore levels measured by spore trap determination
5 Chemical Exposure Hazard home assessment and site-specific chemical analysis
Goal 3 Demonstrate effectiveness of low-cost intervention
Measures
a Differential in environmental exposure factors and health symptom factors before enrolment in study and 6 months after home interventions Evaluated by statistical methods mostly students t-test Power analysis indicates adequate power to detect a 50 change in allergen level in dust at a 95 confidence level with 66 houses in each group
Goal 4 Reduce specific environmental hazards potentially affecting health through in-home education
PrePost Measures
1 IAQ Survey On-site analyses for Temp RH CO2 CO THC TVOC O3
2 Allergen content in house dust lab measurement by immunoassay
3 Total Particulate Analysis on-site laser particle analysis
4 Airborne spore levels measured by spore trap determination
5 Chemical Exposure Hazard home assessment and site-specific chemical analysis
The home environment will also be assessed using a specific set of on-site and laboratory sampling and analyses Once study analyses are complete a report will be written and provided to the family The health and home assessments will be used in the presentation of in-home education related to specific strategies for creating and maintaining a safe and healthy home Once the initial assessments are complete the family will receive a set of standard and targeted interventions that together total no more than 2000 in value If the house is in need of more than 2000 worth of interventions the family would not qualify to participate in this study and would be offered alternative resources through the HHN and the UMKC Center for the City Home Center
The interim controls recommended in the assessment will be provided within 60 days of the in-home education These interim controls include a set of standard interventions that will be provided in all homes and in addition a set of site-specific or targeted interventions based on the assessment findings Six months after the interventions have been implemented the childs health and the home will be assessed using the same instruments procedures questionnaires and the same number and type of samples as in the initial assessment will be taken This will ensure consistency and quality in data gathering
Recruitment of Subjects
The Healthy Homes Network will recruit participants from community physicians and clinics and organizations affiliated with the HHN including health departments and housing authorities the CMH Emergency Room the CMH Allergy Clinic other CMH primary care clinics HHN will recruit through advertising in the media if necessary see proposed ad included but the CMH name or LOGO will not appear in the ad Subjects will be referred to CMH for health evaluations
Expected Sample Size Total study 200 CMH only 200
Inclusion Criteria
Participants that qualify for the study will have one of the following health conditions persistent asthma as defined by NHLBI guidelines chronic respiratory symptoms andor have lead levels equal to or above 15 micrograms per deciliter They must be between the ages of 2 and 17 years of age and stay in the home a minimum of 4 nights per week and they should reside in the KCEEC Defined as the city limits of Kansas City Kansas or Kansas City Missouri They will also have lived in the same housing either rental or self-owned for at least 6 months and have a reasonable expectation of remaining in this housing for at least one additional year
To qualify for the intervention phase of the study done by HHN the home must have no more than 2000 estimated intervention costs Examples of houses that would not qualify include A house that needs a new roof a house with extensive amounts of flaking lead paint a house with significant structural problems
Exclusion Criteria
Any children who do not meet the age and residency requirements Any home with more than 2000 worth of maintenance and repair problems Any home with emergent life threatening conditions Children with other chronic diseases leukemia diabetes etc will be referred through the HHN and CMH to appropriate medical services agencies organizations and other community resources
There is only one study group the immediate intervention group In this group the childs health will be evaluated the home environmental health will be assessed and reported to the family and the family will receive in-home education Within 60 days of the in-home education a series of interim controls for the home will be provided by HHN using a specific set of standard interventions and a site-specific set of targeted interventions based on the assessment findings The home will be checked to ensure the interventions were properly done After 6 months the childs health will be reevaluated and the environmental health of the home will be assessed a second time to evaluate the impact on the childs health
ObservationsMeasurements
Goal 1 Demonstrate improvement in overall health and chronic symptoms in children
PrePost Measures
1 Health Assessment Questionnaire
2 Asthma severity assigned by blinded physician - based on health assessment and spirometry for children 5 years old
3 Medication dosage taken from family health information
4 Blood lead level measured in clinical lab
5 Allergen Specific IgG IgE measured in clinical lab
6 Number of days of school missed taken from family health survey
7 Number of days as in-patient in hospital taken from hospital records
8 Number of visits to physicianER taken from clinic records
9 Quality of life rating from SF12 form
10 Asthma specific quality of life rating Juniper et al
Goal 2 Reduce specific environmental hazards potentially affecting health through interventions
PrePost Measures
1 IAQ Survey On-site analyses for Temp RH CO2 CO THC VOC TVOC
2 Allergen content in house dust lab measurement by immunoassay
3 Total Particulate Analysis on-site laser particle analysis
4 Airborne spore levels measured by spore trap determination
5 Chemical Exposure Hazard home assessment and site-specific chemical analysis
Goal 3 Demonstrate effectiveness of low-cost intervention
Measures
a Differential in environmental exposure factors and health symptom factors before enrolment in study and 6 months after home interventions Evaluated by statistical methods mostly students t-test Power analysis indicates adequate power to detect a 50 change in allergen level in dust at a 95 confidence level with 66 houses in each group
Goal 4 Reduce specific environmental hazards potentially affecting health through in-home education
PrePost Measures
1 IAQ Survey On-site analyses for Temp RH CO2 CO THC TVOC O3
2 Allergen content in house dust lab measurement by immunoassay
3 Total Particulate Analysis on-site laser particle analysis
4 Airborne spore levels measured by spore trap determination
5 Chemical Exposure Hazard home assessment and site-specific chemical analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GL013714 | None | None | None |