Asthma in ChildrenNCT06507943
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
A study testing Promotora Home Visit in people with Asthma in Children, run by Yale University at 1 site in United States.
Trial summary
The purpose of this pilot is to initiate an academic-community partnership and launch a multi-level intervention that includes an asthma exposure pathway (an online decision support and resource) and a health Promotora program that will provide culturally responsive asthma support alongside legal and medical services… Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Promotora Home Visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with a diagnosis of asthma with at least one of the following:
- Oral steroid prescription in past 12m
- ED visit for asthma in past 12m
- Hospital admission for asthma in past 12m
- Asthma control test (ACT) score at visit ≤19
- Concern for asthmogenic exposure in the home (such as mold, pests, smoking, or pollution)
Show all 10Show fewer
- At least one missed follow-up appointment for asthma
- At least one asthma exacerbation in the prior year
- Interested in asthma education (such as education in how to prevent asthma or how to administer medications)
- Concern for medication non-adherence
Who cannot join
- Living outside of New Haven Zip Code
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Health Equity Accelerator (CHEA): Community-Academic Asthma Partnership, Pediatric Asthma Intervention
The purpose of this pilot is to initiate an academic-community partnership and launch a multi-level intervention that includes an asthma exposure pathway (an online decision support and resource) and a health Promotora program that will provide culturally responsive asthma support alongside legal and medical services to improve access to asthma care and ultimately improve asthma-related outcomes in the New Haven region.
Read the detailed description
In this will be a prospective, non-randomized, observational, multi-level pilot intervention, general pediatricians and specialists in New Haven, Connecticut will utilize a newly developed clinical pathway that will be publicly available at the Yale Pediatrics Clinical Pathways website and accessible within the electronic health record (EHR) via integrated software to submit referrals for participants in a Promotora (Community Health Worker) asthma home-visiting intervention.
The Hispanic Federation Promotoras, who are partners in this study who have received Human Subjects research training, will enroll participants in the study. For each participating family, Promotora home visits will be scheduled 6-8 weeks apart, with in-person or virtual visits conducted per the family's preference. The Promotoras, who have received specialized asthma training, will address concerns raised by families, using the clinical pathway as a resource (the pathway will have resources for asthma-related concerns that are raised). A clinician from the study team will be on call at all times for the Promotoras in case urgent questions arise, and weekly case-conferences will be arranged to discuss any additional needs for support.
In this study, the primary outcomes will include measures of feasibility of both Promotora home visits and pathway utilization. The investigators will evaluate secondary outcomes using an interrupted time series analysis to evaluate asthma-related outcomes. In addition to survey data, asthma exacerbation metrics will be collected from the electronic health record.
- Conditions
- Asthma in Children
- Being tested
- Promotora Home Visit
- Keywords
- Medical Legal Partnership, Community Health Worker, Health Harming Legal Needs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotora Home VisitBehavioural
For each participating family, Promotora home visits will be scheduled 6-8 weeks apart, with in-person or virtual visits conducted per the family's preference. The visits will begin with a survey which will evaluate concerns related to asthma for the child and the family, including their asthma control (via the ACT), their home environment (via screening for environmental exposures), and quality of life for the child. These surveys will be available in both online or physical forms for potential connectivity concerns, and Promotoras will have IPads for the online forms. The Promotoras, who have received specialized asthma training, will then address concerns raised by families, using the Clinical Pathway which will have resources for asthma-related concerns that are raised.
| Study group | Role | What they receive |
|---|---|---|
| Promotora | Experimental | Two Hispanic Federation Promotoras (community health workers) will provide culturally competent, bilingual home visits for asthma-related education and evaluation and support for health-harming legal needs (e.g., mold, rodents), including an initial visit and a follow-up visit 6-8 weeks later. Receives: Behavioral: Promotora Home Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Referrals Resulting in Home Visit, to Assess Feasibility of Promotora Visits
Percent of referred participants (from all referrals placed) to the newly-established asthma home visiting Promotora Program that resulted in a home visit (in-person or virtual)
Measured: One Year
Percent of clinicians who use pathway, to assess feasibility of asthma pathway use
Percent of clinicians at participating practices who have accessed the asthma intervention pathway (using data from pathway utilization metrics)
Measured: One Year
Percent of patients for whom the pathway is used, to assess feasibility of asthma pathway use
Percent of patients for whom a clinician accessed the asthma pathway (using pathway utilization metrics) out of total potential children for whom it could be used (using deidentified electronic health (EHR) record data tool)
Measured: One Year
Count of use of individual asthma pathway component use
Count of use of individual asthma pathway components (using pathway utilization metrics)
Measured: One Year
Secondary outcomes (6)
Mean Asthma Control Test (ACT) for 4-11 years scores
The ACT (for 4-11 years) is a seven-item survey with likert scales for caregivers (3 questions, scores 0-5) and children (5 questions, scores 0-3) together. It is used to evaluate asthma control with total score range of 0 (poorly controlled) to 27 (well-controlled)
Measured: Baseline and 6-8 weeks later
Mean Pediatric Quality of Life (Peds-QL) scores
The Peds-QL is a 15 item survey with likert scales (0-4), with transformed scores out of 100, with a score range of 0 (poor quality of life) to 100 (high quality life).
Measured: Baseline and 6-8 weeks later
Mean number of hospital admissions for asthma
Total number of hospital admissions for asthma, evaluated via manual count via chart review.
Measured: Two years (year before and year after intervention)
Mean number of emergency department (ED) visits for asthma
Total number of ED visits for asthma, evaluated via manual count via chart review.
Measured: Two years (year before and year after intervention)
Mean number of urgent visits for asthma
Total number of urgent visits for asthma, evaluated via manual count via chart review.
Measured: Two years (year before and year after intervention)
Mean number of oral steroid prescriptions for asthma
Total number of oral steroid prescriptions for asthma, evaluated via manual count via chart review.
Measured: Two years (year before and year after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start16 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Hispanic Federation, Inc.
- Responsible party
- Sponsor
- Investigators
- Julia Rosenberg, MD MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507943
- Sponsor's protocol ID
- 2000037314
- Status last verified
- Oct 2026
- First submitted
- 11 Jul 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Equity Accelerator (CHEA): Community-Academic Asthma Partnership, Pediatric Asthma Intervention
- ClinicalTrials.gov ID
- NCT06507943
- Acronym / sponsor ID
- 2000037314
- Conditions
- Asthma in Children
- Keywords
- Medical Legal Partnership, Community Health Worker, Health Harming Legal Needs
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Hispanic Federation, Inc.
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Jul 2024 (actual)
- 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 purpose of this pilot is to initiate an academic-community partnership and launch a multi-level intervention that includes an asthma exposure pathway (an online decision support and resource) and a health Promotora program that will provide culturally responsive asthma support alongside legal and medical services to improve access to asthma care and ultimately improve asthma-related outcomes in the New Haven region.
Detailed description
In this will be a prospective, non-randomized, observational, multi-level pilot intervention, general pediatricians and specialists in New Haven, Connecticut will utilize a newly developed clinical pathway that will be publicly available at the Yale Pediatrics Clinical Pathways website and accessible within the electronic health record (EHR) via integrated software to submit referrals for participants in a Promotora (Community Health Worker) asthma home-visiting intervention.
The Hispanic Federation Promotoras, who are partners in this study who have received Human Subjects research training, will enroll participants in the study. For each participating family, Promotora home visits will be scheduled 6-8 weeks apart, with in-person or virtual visits conducted per the family's preference. The Promotoras, who have received specialized asthma training, will address concerns raised by families, using the clinical pathway as a resource (the pathway will have resources for asthma-related concerns that are raised). A clinician from the study team will be on call at all times for the Promotoras in case urgent questions arise, and weekly case-conferences will be arranged to discuss any additional needs for support.
In this study, the primary outcomes will include measures of feasibility of both Promotora home visits and pathway utilization. The investigators will evaluate secondary outcomes using an interrupted time series analysis to evaluate asthma-related outcomes. In addition to survey data, asthma exacerbation metrics will be collected from the electronic health record.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Promotora | Experimental | Behavioral: Promotora Home VisitTwo Hispanic Federation Promotoras (community health workers) will provide culturally competent, bilingual home visits for asthma-related education and evaluation and support for health-harming legal needs (e.g., mold, rodents), including an initial visit and a follow-up visit 6-8 weeks later. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Oral steroid prescription in past 12m
- ED visit for asthma in past 12m
- Hospital admission for asthma in past 12m
- Asthma control test (ACT) score at visit ≤19
- Concern for asthmogenic exposure in the home (such as mold, pests, smoking, or pollution)
Key exclusion criteria (1 listed)
- Living outside of New Haven Zip Code
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 |
|---|---|---|
| Promotora Home VisitFor each participating family, Promotora home visits will be scheduled 6-8 weeks apart, with in-person or virtual visits conducted per the family's preference. The visits will begin with a survey which will evaluate concerns related to asthma for the child and the family, including their asthma control (via the ACT), their home environment (via screening for environmental exposures), and quality of life for the child. These surveys will be available in both online or physical forms for potential connectivity concerns, and Promotoras will have IPads for the online forms. The Promotoras, who have received specialized asthma training, will then address concerns raised by families, using the Clinical Pathway which will have resources for asthma-related concerns that are raised. | Behavioural | Promotora |
Primary outcome
Percentage of Referrals Resulting in Home Visit, to Assess Feasibility of Promotora Visits
Time frame: One Year
Percent of referred participants (from all referrals placed) to the newly-established asthma home visiting Promotora Program that resulted in a home visit (in-person or virtual)
Percent of clinicians who use pathway, to assess feasibility of asthma pathway use
Time frame: One Year
Percent of clinicians at participating practices who have accessed the asthma intervention pathway (using data from pathway utilization metrics)
Percent of patients for whom the pathway is used, to assess feasibility of asthma pathway use
Time frame: One Year
Percent of patients for whom a clinician accessed the asthma pathway (using pathway utilization metrics) out of total potential children for whom it could be used (using deidentified electronic health (EHR) record data tool)
Count of use of individual asthma pathway component use
Time frame: One Year
Count of use of individual asthma pathway components (using pathway utilization metrics)
6 secondary outcomes
Mean Asthma Control Test (ACT) for 4-11 years scores
Time frame: Baseline and 6-8 weeks later
Mean Pediatric Quality of Life (Peds-QL) scores
Time frame: Baseline and 6-8 weeks later
Mean number of hospital admissions for asthma
Time frame: Two years (year before and year after intervention)
Mean number of emergency department (ED) visits for asthma
Time frame: Two years (year before and year after intervention)
Mean number of urgent visits for asthma
Time frame: Two years (year before and year after intervention)
Mean number of oral steroid prescriptions for asthma
Time frame: Two years (year before and year after intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Julia Rosenberg, MD MHS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotora Home Visit in people with Asthma in Children, run by Yale University 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 10 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Referrals Resulting in Home Visit, to Assess Feasibility of Promotora Visits (time frame: One Year). The study lists 4 primary outcomes in all. 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 27 Oct 2026.