Brief Summary
The investigators propose to test the hypothesis that a home-based asthma intervention, the Wee Wheezers program, delivered by the Community Health Workers and tailored to the needs of the investigators community, will improve anti-inflammatory medication adherence, parental asthma knowledge and management behaviors, which in turn will reduce asthma morbidity (defined as days with asthma symptoms) and health care utilization (defined as asthma-related Emergency Department visits) among low-income, minority children with persistent asthma in the Bronx.
Brief Title
A Community Health Worker Home Intervention to Improve Pediatric Asthma Outcomes
Detailed Description
Asthma disproportionately burdens low-income inner city and minority children residing in inner cities. Daily use of inhaled corticosteroids (ICS) control symptoms and reduce asthma morbidity. Less then 50% of children with persistent asthma adhere to such therapy. Poor adherence to ICS medications is one of the major contributors to asthma morbidity. One way to reduce asthma disparities is to work in partnership with communities. Community Health Workers (CHWs) share the ethnic, cultural, social, and environmental experiences of the people in the community. Although, CHW home interventions have been successful in reducing asthma allergens, no studies using CHWs to deliver a previously identified evidence-based home intervention to improve ICS adherence and health outcomes in a population of inner-city, minority children with persistent asthma have been found. Objective: To evaluate the effectiveness of an evidence-based asthma home intervention, the Wee Wheezers program, tailored to the needs of the community and delivered by CHWs, in improving medication adherence, health outcomes and parental management behaviors among low-income, minority children with persistent asthma in the Bronx.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Asthma
Eligibility Criteria
Inclusion Criteria:
* children 2-9 years of age with persistent asthma
* children being currently prescribed ICS in the Metered Dose Inhaler (MDI) form
* if the child is 2 years of age at the time of the recruitment, he/she must have at least two prior episodes of wheezing treated and reversible with beta-agonists
* primary caregiver speaks English or Spanish
* family has a phone.
Exclusion Criteria:
* children with other chronic pulmonary diseases (e.g, cystic fibrosis, bronchopulmonary dysplasia) or presence of tracheostomy
* children 2-9 years of age with persistent asthma
* children being currently prescribed ICS in the Metered Dose Inhaler (MDI) form
* if the child is 2 years of age at the time of the recruitment, he/she must have at least two prior episodes of wheezing treated and reversible with beta-agonists
* primary caregiver speaks English or Spanish
* family has a phone.
Exclusion Criteria:
* children with other chronic pulmonary diseases (e.g, cystic fibrosis, bronchopulmonary dysplasia) or presence of tracheostomy
Inclusion Criteria
Inclusion Criteria:
* children 2-9 years of age with persistent asthma
* children being currently prescribed ICS in the Metered Dose Inhaler (MDI) form
* if the child is 2 years of age at the time of the recruitment, he/she must have at least two prior episodes of wheezing treated and reversible with beta-agonists
* primary caregiver speaks English or Spanish
* family has a phone.
* children 2-9 years of age with persistent asthma
* children being currently prescribed ICS in the Metered Dose Inhaler (MDI) form
* if the child is 2 years of age at the time of the recruitment, he/she must have at least two prior episodes of wheezing treated and reversible with beta-agonists
* primary caregiver speaks English or Spanish
* family has a phone.
Gender
All
Gender Based
false
Keywords
asthma
children
community health workers
home intervention
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
9 Years
Minimum Age
2 Years
NCT Id
NCT01003340
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
07-10-360
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized Controlled Trial of a Community Health Worker Home-Based Asthma Intervention
Primary Outcomes
Outcome Description
average of asthma symptom days
Outcome Measure
mean number of asthma symptom days
Outcome Time Frame
baseline and every 8 weeks during the 12-months study period
Secondary Ids
Secondary Id
CG-120837-N
Secondary Outcomes
Outcome Description
survey evaluating medication adherence
Outcome Time Frame
baseline, 4 weeks, 8 weeks, and 12 weeks after beginning of intervention
Outcome Measure
adherence to Inhaled Corticosteroid
Outcome Description
number of ED visits
Outcome Time Frame
baseline, 3-, 6- and 12-months follow-up
Outcome Measure
asthma-related Emergency Department visits
Outcome Description
survey evaluating asthma knowledge and management behavior
Outcome Time Frame
baseline, 3-, 6- and 12-months follow-up
Outcome Measure
parental asthma knowledge and management behaviors
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
9
Minimum Age Number (converted to Years and rounded down)
2
Investigators
Investigator Type
Principal Investigator
Investigator Name
Marina Reznik
Investigator Email
MREZNIK@montefiore.org
Investigator Phone
718-405-5260
Categories Mesh Debug
Asthma and Other Respiratory Diseases --- BRONCHIAL DISEASES
Lung --- BRONCHIAL DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Lung --- LUNG DISEASES, OBSTRUCTIVE
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY HYPERSENSITIVITY
Lung --- RESPIRATORY HYPERSENSITIVITY
Lung --- HYPERSENSITIVITY, IMMEDIATE
Lung --- HYPERSENSITIVITY
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
ASTHMA
BRONCHIAL DISEASES
RESPIRATORY TRACT DISEASES
LUNG DISEASES, OBSTRUCTIVE
LUNG DISEASES
RESPIRATORY HYPERSENSITIVITY
HYPERSENSITIVITY, IMMEDIATE
HYPERSENSITIVITY
IMMUNE SYSTEM DISEASES