Childhood AsthmaCAAANCT00839046
A Community-based Participatory Research (CBPR) Intervention for Childhood Asthma Using Air Filters and Air Conditioners
A study testing Community Health Worker Intervention, Air Filter and Air Filter and Air Conditioner in people with Childhood Asthma, run by University of Michigan at 1 site in United States.
Trial summary
The burden of childhood asthma is borne disproportionately by children living in poverty and in urban centers, many of whom are from communities of color and are at greater risk for environmental exposures. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Childhood Asthma
- What is being tested?
- Community Health Worker Intervention, Air Filter and Air Filter and Air Conditioner
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Residents of EastSide or Southwest Detroit
- child in the family between age of 6-12 with responses to the screening questionnaire consistent with known or probable persistent (mild, moderate, or severe) asthma
Who cannot join
- the family participated in our previous intervention study in Detroit
- the family experiences continuous homelessness during the period of enrollment;
- the child spends fewer than 80% of nights at the primary household during the school year
- the child has a physical or mental handicap that would preclude successful completion of the child survey and spirometry.
- the child spends fewer than 28 consecutive nights (4 weeks) during the summer (i.e., June, July, and August) at the primary household
- the family is monolingual in a language other than English or Spanish;
Show all 10Show fewer
- the electrical wiring of the house is inadequate for use of the air filter/air conditioner (AF/AC)
- the home lacks a closable door to the room where the child usually sleeps
- there is already an existent window AC unit in the room where the child usually sleeps
- the window in the room where the child usually sleeps will not support the addition of a window AC unit.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan
Ann Arbor, Michigan, 48109-2029
About this study
Official title: A Community Based Participatory Research Intervention for Childhood Asthma Using Air Filters and Air Conditioners
The burden of childhood asthma is borne disproportionately by children living in poverty and in urban centers, many of whom are from communities of color and are at greater risk for environmental exposures. Given the complex interaction of physical and social environmental factors on childhood asthma, there have been increasing calls for comprehensive efforts using a community-based participatory research (CBPR) approach. Community Action Against Asthma is a long standing CBPR partnership in Detroit, Michigan, composed of representatives from community-based organizations, health and human service agencies, and academia. All members of the partnership have been actively involved in the development of the CBPR project proposed here. The specific aims are: 1) to test the efficacy of air filters (AFs) separately and when combined with air conditioners (ACs) to reduce exposure to particulate matter (PM), over and above a standard community health worker home visit (standard) intervention; 2) to test the association between any reduction in PM exposure through the use of AFs separately and when combined with ACs over and above a standard intervention and health outcomes in children with asthma; 3) to elucidate the causal pathways by which any intervention-related improvements in children's asthma-related health status is occurring. One hundred and fifty households in Detroit, Michigan with at least one child with mild persistent or moderate to severe persistent asthma will be enrolled to participate in the study. Households will be randomly assigned to one of three groups: a standard household intervention (or control) group; an AF only intervention group; or an AF+AC intervention group. Extensive health and exposure measures will be undertaken during the course of the 12 -month intervention. Given the role of PM in children's asthma-related health and the higher concentrations of PM in microenvironments, there is a need to test the efficacy and efficiency of novel approaches to reducing indoor air pollutants. Doing so using a CBPR approach will enhance the relevance and ultimately the success of this proposed research.
Read the detailed description
For the proposed study we will conduct a randomized controlled trial (RCT) comparing a standard community health worker home visit intervention (the standard intervention) to an Air Filter(AF) only intervention that adds the use of an AF in the child's bedroom to the standard intervention (AF only intervention) and an Air Filter(AF)+ Air Conditioner (AC) intervention that adds the use of an AF and AC in the child's bedroom to the standard intervention (AF+AC intervention) (Figure 1). We will test whether the addition of AFs (and, in the warmer months, ACs) to the standard intervention, as compared to the standard intervention will: (1) further lower children's exposure to PM (Specific Aims 1a, 1b), and (2) further improve asthma-related health status of children (Aims 2a, 2b). One hundred and fifty Detroit households with at least one child aged 6 to 12 with symptoms consistent with persistent asthma (mild, moderate, or severe) will be enrolled in the study . Following collection of baseline data, households will be randomly assigned to receive one of three interventions: the standard household intervention, the AF only intervention, or the AF+AC intervention. Participants assigned to the AF only intervention group will receive AFs at the start of the 12-month intervention (Summer/Fall 2008). Those assigned to the AF+AC intervention group will receive AFs at the start of the intervention period but ACs will not be in place during the first summer of the intervention, but will be installed in June 2009 prior to the second summer of the intervention (Figure 2). Data will be collected across all seasons (Fall 2008 through Winter 2009) which will enable us to evaluate directly the exposure and health outcome effects (Specific Aims 1a and 2a, respectively) of the addition of AFs alone to the standard intervention as well as the exposure and health outcome effects of the AFs augmented by ACs (Aims 1b, 2b). This design will also allow for comparisons, adjusted for any changes in the exposure and health status of the intervention groups, of the combined effect of the AC and AF to that of the AF alone.
- Conditions
- Childhood Asthma
- Being tested
- Community Health Worker Intervention, Air Filter, Air Filter and Air Conditioner
- Keywords
- Pediatric Asthma, Air Filters, Indoor Particulate Matter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker InterventionBehavioural
Also called community health workers
The Community Health Worker (CHW) intervention consists of visits by CHWS to help families reduce children's exposure to common asthma triggers (allergens and irritants) in the indoor environment. The content of the CHW visits and the materials distributed will follow NHLBI Expert Panel Report 2 recommendations. Each household will receive 6 visits over a 12-month period in which the CHW will provide education on environmental triggers (e.g., reduction of dust mites, cockroaches, cat and dog dander, and environmental tobacco smoke); materials including vacuum cleaners with HEPA filters, mattress and pillow covers, and cleaning supplies; social support to the caregivers; and, if indicated, referrals to other services.
Air FilterOther
Fifty households will receive an Air Filter, in addition to receiving the standard community health worker intervention. These households will receive a HEPA room AF (Whirlpool 510 or equivalent), a relatively high capacity unit that can be quietly operated. Similar to other studies the filter will be placed in the room where the child sleeps. The HEPA AF will be installed at the beginning of the intervention period.
Air Filter and Air ConditionerOther
Also called Air Conditioner, Air Filter
Fifty households will receive the air filter and the air conditioner, in addition to receiving the standard community health worker intervention. The air filter will be installed at the beginning of the intervention, after baseline measurement. In the spring of the year (2009), a small window AC unit (Whirlpool Designer Style ACQ058MM or equivalent) will also be installed in the room where the child sleeps.
| Study group | Role | What they receive |
|---|---|---|
| 1 Community Health Worker Intervention | Active comparator | This is the active control group, which all 150 participants will receive. It consists of visits from trained community health workers, who will provide asthma education, as well as provision of equipment and supplies to reduce indoor environmental exposures for asthma. These will include: vacuum cleaners, mattress and pillow covers, cleaning supplies. Receives: Behavioral: Community Health Worker Intervention |
| 2 Air Filter | Experimental | The 50 families in the Air Filter Arm will receive an air filter in addition to the standard community health worker intervention. The Air Filter will be installed right after baseline measurements in the home. Receives: Other: Air Filter |
| 3 Air Filter and Air Conditioner | Experimental | Fifty families will be assigned to the "Air Filter and Air Conditioner" Arm. In addition to the standard community health worker intervention, they will receive an air filter and an air conditioner (for the warmer months). Receives: Other: Air Filter and Air Conditioner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Lung Function in Children with Asthma
Measured: End of one year of intervention
Secondary outcomes (1)
Reduced Particulate Matter (PM) in the home of the children with asthma
Measured: End of one year intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startAug 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood AsthmaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Toby Lewis, University of Michigan
- Investigators
- Toby C Lewis, MD, Principal investigator, University of Michigan School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839046
- Sponsor's protocol ID
- R01ES014566
- Other IDs
- R01ES014566
- Acronym
- CAAA
- Status last verified
- Jul 2017
- First submitted
- 5 Feb 2009
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Based Participatory Research Intervention for Childhood Asthma Using Air Filters and Air Conditioners
- ClinicalTrials.gov ID
- NCT00839046
- Acronym / sponsor ID
- CAAA / R01ES014566
- Conditions
- Childhood Asthma
- Keywords
- Pediatric Asthma, Air Filters, Indoor Particulate Matter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- Aug 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The burden of childhood asthma is borne disproportionately by children living in poverty and in urban centers, many of whom are from communities of color and are at greater risk for environmental exposures. Given the complex interaction of physical and social environmental factors on childhood asthma, there have been increasing calls for comprehensive efforts using a community-based participatory research (CBPR) approach. Community Action Against Asthma is a long standing CBPR partnership in Detroit, Michigan, composed of representatives from community-based organizations, health and human service agencies, and academia. All members of the partnership have been actively involved in the development of the CBPR project proposed here. The specific aims are: 1) to test the efficacy of air filters (AFs) separately and when combined with air conditioners (ACs) to reduce exposure to particulate matter (PM), over and above a standard community health worker home visit (standard) intervention; 2) to test the association between any reduction in PM exposure through the use of AFs separately and when combined with ACs over and above a standard intervention and health outcomes in children with asthma; 3) to elucidate the causal pathways by which any intervention-related improvements in children's asthma-related health status is occurring. One hundred and fifty households in Detroit, Michigan with at least one child with mild persistent or moderate to severe persistent asthma will be enrolled to participate in the study. Households will be randomly assigned to one of three groups: a standard household intervention (or control) group; an AF only intervention group; or an AF+AC intervention group. Extensive health and exposure measures will be undertaken during the course of the 12 -month intervention. Given the role of PM in children's asthma-related health and the higher concentrations of PM in microenvironments, there is a need to test the efficacy and efficiency of novel approaches to reducing indoor air pollutants. Doing so using a CBPR approach will enhance the relevance and ultimately the success of this proposed research.
Detailed description
For the proposed study we will conduct a randomized controlled trial (RCT) comparing a standard community health worker home visit intervention (the standard intervention) to an Air Filter(AF) only intervention that adds the use of an AF in the child's bedroom to the standard intervention (AF only intervention) and an Air Filter(AF)+ Air Conditioner (AC) intervention that adds the use of an AF and AC in the child's bedroom to the standard intervention (AF+AC intervention) (Figure 1). We will test whether the addition of AFs (and, in the warmer months, ACs) to the standard intervention, as compared to the standard intervention will: (1) further lower children's exposure to PM (Specific Aims 1a, 1b), and (2) further improve asthma-related health status of children (Aims 2a, 2b). One hundred and fifty Detroit households with at least one child aged 6 to 12 with symptoms consistent with persistent asthma (mild, moderate, or severe) will be enrolled in the study . Following collection of baseline data, households will be randomly assigned to receive one of three interventions: the standard household intervention, the AF only intervention, or the AF+AC intervention. Participants assigned to the AF only intervention group will receive AFs at the start of the 12-month intervention (Summer/Fall 2008). Those assigned to the AF+AC intervention group will receive AFs at the start of the intervention period but ACs will not be in place during the first summer of the intervention, but will be installed in June 2009 prior to the second summer of the intervention (Figure 2). Data will be collected across all seasons (Fall 2008 through Winter 2009) which will enable us to evaluate directly the exposure and health outcome effects (Specific Aims 1a and 2a, respectively) of the addition of AFs alone to the standard intervention as well as the exposure and health outcome effects of the AFs augmented by ACs (Aims 1b, 2b). This design will also allow for comparisons, adjusted for any changes in the exposure and health status of the intervention groups, of the combined effect of the AC and AF to that of the AF alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Community Health Worker Intervention | Active comparator | Behavioral: Community Health Worker InterventionThis is the active control group, which all 150 participants will receive. It consists of visits from trained community health workers, who will provide asthma education, as well as provision of equipment and supplies to reduce indoor environmental exposures for asthma. These will include: vacuum cleaners, mattress and pillow covers, cleaning supplies. |
| 2 Air Filter | Experimental | Other: Air FilterThe 50 families in the Air Filter Arm will receive an air filter in addition to the standard community health worker intervention. The Air Filter will be installed right after baseline measurements in the home. |
| 3 Air Filter and Air Conditioner | Experimental | Other: Air Filter and Air ConditionerFifty families will be assigned to the "Air Filter and Air Conditioner" Arm. In addition to the standard community health worker intervention, they will receive an air filter and an air conditioner (for the warmer months). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Residents of EastSide or Southwest Detroit
- child in the family between age of 6-12 with responses to the screening questionnaire consistent with known or probable persistent (mild, moderate, or severe) asthma
Key exclusion criteria (10 listed)
- the family participated in our previous intervention study in Detroit
- the family experiences continuous homelessness during the period of enrollment;
- the child spends fewer than 80% of nights at the primary household during the school year
- the child has a physical or mental handicap that would preclude successful completion of the child survey and spirometry.
- the child spends fewer than 28 consecutive nights (4 weeks) during the summer (i.e., June, July, and August) at the primary household
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health Worker InterventionAlso: community health workersThe Community Health Worker (CHW) intervention consists of visits by CHWS to help families reduce children's exposure to common asthma triggers (allergens and irritants) in the indoor environment. The content of the CHW visits and the materials distributed will follow NHLBI Expert Panel Report 2 recommendations. Each household will receive 6 visits over a 12-month period in which the CHW will provide education on environmental triggers (e.g., reduction of dust mites, cockroaches, cat and dog dander, and environmental tobacco smoke); materials including vacuum cleaners with HEPA filters, mattress and pillow covers, and cleaning supplies; social support to the caregivers; and, if indicated, referrals to other services. | Behavioural | 1 Community Health Worker Intervention |
| Air FilterFifty households will receive an Air Filter, in addition to receiving the standard community health worker intervention. These households will receive a HEPA room AF (Whirlpool 510 or equivalent), a relatively high capacity unit that can be quietly operated. Similar to other studies the filter will be placed in the room where the child sleeps. The HEPA AF will be installed at the beginning of the intervention period. | Other | 2 Air Filter |
| Air Filter and Air ConditionerAlso: Air Conditioner, Air FilterFifty households will receive the air filter and the air conditioner, in addition to receiving the standard community health worker intervention. The air filter will be installed at the beginning of the intervention, after baseline measurement. In the spring of the year (2009), a small window AC unit (Whirlpool Designer Style ACQ058MM or equivalent) will also be installed in the room where the child sleeps. | Other | 3 Air Filter and Air Conditioner |
Primary outcome
Improved Lung Function in Children with Asthma
Time frame: End of one year of intervention
1 secondary outcome
Reduced Particulate Matter (PM) in the home of the children with asthma
Time frame: End of one year intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toby C Lewis, MD principal investigator
University of Michigan School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker Intervention, Air Filter and Air Filter and Air Conditioner in people with Childhood Asthma, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved Lung Function in Children with Asthma (time frame: End of one year of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.