Suspended
Kansas City Community Environmental Remediation And Training (KC CERT)
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What is being tested
Basic home repair+ Asthma Trigger Education
Behavioral
Who is being recruted
Asthma+ Rhinitis+ Allergy
From 2 to 17 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed
Other Study
Interventional
Study Start: March 2003
See protocol details
Summary
Principal SponsorChildren's Mercy Hospital Kansas City
Last updated: January 20, 2021
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2003Actual date on which the first participant was enrolled.
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 families/communities 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.
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 child's 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, and/or 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 child's 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 child's health will be reevaluated and the environmental health of the home will be assessed a second time to evaluate the impact on the child's health.
Observations/Measurements:
Goal 1: Demonstrate improvement in overall health and chronic symptoms in children
Pre/Post 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 physician/ER (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
Pre/Post 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.
Pre/Post 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)
Principal SponsorChildren's Mercy Hospital Kansas City
Last updated: January 20, 2021
Sourced from a government-validated database.Claim as a partner
ProtocolThis section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
200 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Other Study
Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.
How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.
Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.
Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.
Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.
Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.
How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.
Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.
Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
EligibilityResearchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 2 to 17 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Asthma
Rhinitis
Allergy
Criteria
10 inclusion criteria required to participate
articipants that qualify for the study will have one of the following health conditions
Persistent asthma as defined by NHLBI guidelines
Chronic respiratory symptoms
And/or have lead levels equal to or above 15 micrograms per deciliter
Show More Criteria
3 exclusion criteria prevent from participating
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
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Study PlanFind out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study CentersThese are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
SuspendedOne Study Center