Promotora Home Visits for Childhood Asthma

Overseen By Julie Flom, MD MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Living outside New Haven

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve asthma care for children in the New Haven area by offering home visits from bilingual community health workers, known as Promotoras. These visits provide asthma education and support, addressing issues like mold or pests that may worsen asthma. Children with asthma who have recently needed oral steroids, visited the emergency room, or have concerns about asthma triggers at home might be a good fit. The program focuses on enhancing access to asthma care and improving health outcomes through personalized, culturally responsive support.

As an unphased trial, this study offers a unique opportunity for participants to receive personalized support and contribute to improving asthma care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Promotora Home Visit is safe for childhood asthma support?

Research has shown that home visits by Promotoras, community health workers, positively impact managing childhood asthma. For instance, one study with 95 children found that these visits significantly reduced missed school days from 16 to 10.7. Another study found that asthma education at home improved the emotional well-being of families dealing with asthma.

Overall, these studies suggest that Promotora home visits are helpful and well-accepted. The available data reported no safety issues or negative effects related to the Promotora visits. This indicates that the treatment is safe and effective in managing asthma symptoms and improving family well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Promotora Home Visit approach for childhood asthma because it offers a culturally tailored, bilingual intervention that addresses both medical and environmental aspects of asthma management. Unlike standard treatments, which often focus solely on medication and clinical visits, this approach involves community health workers visiting homes to provide asthma education and support in dealing with health-harming legal needs like mold and rodents. This personalized, holistic method aims to empower families with the tools and knowledge to manage asthma effectively in their everyday environments, potentially improving outcomes beyond what traditional methods achieve.

What evidence suggests that Promotora Home Visits are effective for childhood asthma?

Research has shown that home visits for children with asthma can reduce school absences and improve breathing. In this trial, community health workers, known as promotoras, will provide culturally competent, bilingual home visits for asthma-related education and evaluation. Promotoras have effectively kept children engaged in asthma care programs like Breathmobile™, which is crucial for managing asthma. They have successfully helped manage childhood asthma by reducing symptoms and emergency room visits. Strong evidence indicates that promotoras can improve asthma outcomes by offering culturally sensitive support and education. Overall, these programs significantly help control asthma in children. ^{1 6 7 8 9}

Who Is on the Research Team?

Julia Rosenberg, MD MHS

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for children with asthma in the New Haven region. It's designed to help those who may benefit from extra support managing their condition, including access to medical and legal services.

Inclusion Criteria

Children with a diagnosis of asthma with at least one of the following: Oral steroid prescription in past 12 months, ED visit for asthma in past 12 months, Hospital admission for asthma in past 12 months, Asthma control test (ACT) score at visit ≤19, Concern for asthmogenic exposure in the home (such as mold, pests, smoking, or pollution), 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

Exclusion Criteria

Living outside of New Haven Zip Code

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Promotora Home Visits

Promotoras conduct home visits for asthma-related education and support, addressing health-harming legal needs

6-8 weeks

Initial visit and follow-up visit 6-8 weeks later

Follow-up

Participants are monitored for asthma-related outcomes and pathway utilization

One year

Long-term Monitoring

Evaluation of asthma exacerbation metrics and other secondary outcomes

Two years

What Are the Treatments Tested in This Trial?

Interventions

• Promotora Home Visit

Trial Overview The study tests a multi-level intervention that includes an online decision support tool for asthma care and home visits by health Promotoras (community health workers) to provide culturally tailored assistance.

How Is the Trial Designed?

Group I: Promotora Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Hispanic Federation, Inc.

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

Home visits in an asthma self-management intervention for rural families were effective in tailoring education to individual family needs, utilizing the home environment to enhance learning.

The study demonstrated that home visits helped maintain high family retention rates over the year-long intervention without adding extra burden to families managing asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home visiting for intervention delivery to improve rural family asthma management. Horner, SD.[2019]

In a 10-year follow-up study of 62 children with asthma, 50% outgrew their condition, with non-atopic children showing a complete remission, while 67% of atopic children continued to experience symptoms.

Key risk factors for persistent asthma included bronchial hyper-responsiveness and rhinitis, while higher levels of allergen-induced CD4(+)CD25(+) T cells in atopic children suggested a potential immunological mechanism for asthma remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for persistence of asthma in children: 10-year follow-up. Aydogan, M., Ozen, A., Akkoc, T., et al.[2015]

Primary care providers found the asthma home visiting program highly beneficial, particularly valuing the environmental assessments (95%), asthma education (91%), and addressing environmental issues (86%).

All surveyed providers expressed a willingness to continue referring patients to the program, indicating strong support for its utility in improving pediatric asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary care provider perceptions of an asthma home visiting program. Hatoun, J., Barrieau, DJ., Bryson, EA., et al.[2023]

The Preschool Asthma Program, involving 25 child-parent pairs over 7 sessions, significantly reduced physician visits for asthma (p = 0.0013) and improved parents' confidence in managing their child's asthma.

Participants showed a significant improvement in symptom severity scores (p < 0.001), although there were no changes in the frequency of asthma episodes or pulmonary function tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying hypnosis in a preschool family asthma education program: uses of storytelling, imagery, and relaxation. Kohen, DP., Wynne, E.[2009]

The World Health Organization highlights that asthma is a major health issue affecting hundreds of millions, particularly children, and emphasizes the need for better diagnosis and treatment.

A multicentric pediatric study in Germany, involving 176 participants, aims to explore the molecular pathways of asthma exacerbations and identify biomarkers to improve diagnostics and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Current Asthma-Preventive Measures Appropriately Face the World Health Organization's Concerns: A Study Presentation of a New Clinical, Prospective, Multicentric Pediatric Asthma Exacerbation Cohort in Germany. Aydin, M., Naumova, EA., Lutz, S., et al.[2020]

A 2-year study involving 95 children showed that a comprehensive asthma management program led to significantly less school absenteeism (10.7 days vs. 16.0 days) and improved small airway function after one year.

The program also resulted in better metered aerosol technique and fewer hospital days for asthma-related issues (3.67 days vs. 11.2 days), but the benefits diminished after the program ended, highlighting the need for ongoing management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled trial of a home and ambulatory program for asthmatic children. Hughes, DM., McLeod, M., Garner, B., et al.[2017]

The Aironet educational program significantly reduced the number of asthma attacks in children with intermittent or mild persistent asthma, with an average of 1.65 attacks in the education group compared to 2.34 in the control group over 12 months.

Parents of children who experienced three or more asthma attacks at baseline showed a greater improvement in their knowledge of asthma after participating in the Aironet program, highlighting its effectiveness in both managing the disease and educating families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effects of a Long-term Educational Program for children with asthma - Aironet. A 1-yr randomized controlled trial. Indinnimeo, L., Bonci, E., Capra, L., et al.[2009]

There is a growing recognition that patient-reported outcome measures (PROMs) are crucial for understanding children's health, particularly in allergy and asthma, but there are fewer validated PROMs available for children compared to adults.

The review highlights a significant gap in the use of PROMs in routine clinical care for children, emphasizing the need for more research on their acceptability, integration into clinical assessments, and responsiveness to treatment changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures for allergy and asthma in children. Soyiri, IN., Nwaru, BI., Sheikh, A.[2018]

Citations

1. withpower.com withpower.com/trial/phase-asthma-7-2024-d9730

Promotora Home Visits for Childhood Asthma Research shows that home visiting programs for children with asthma can lead to better health outcomes, such as fewer school absences and improved lung function ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25405362/

Effectiveness of a Promotora Home Visitation Program for ... The addition of a promotora HV program proved effective in providing greater retention in the Breathmobile™ program essential for asthma control.

3. tandfonline.com tandfonline.com/doi/abs/10.3109/02770903.2014.986738

Effectiveness of a promotora home visitation program for ... Conclusions: The addition of a promotora HV program proved effective in providing greater retention in the Breathmobile™ program essential for asthma control.

4. naleo.org naleo.org/wp-content/uploads/2019/11/NALEO_LegislativeSummit_Res11_Dr.Flores_10.25.19.pdf

Community Health Workers, Promotores, and Parent Mentors Solid evidence already exists that CHWs, promotores, and Parent Mentors are highly effective in managing childhood asthma, reducing miscarriages and low birth- ...

5. researchgate.net researchgate.net/publication/280997528_Community_Health_Worker_Home_Visits_for_Medicaid-Enrolled_Children_With_Asthma_Effects_on_Asthma_Outcomes_and_Costs

Effects on Asthma Outcomes and Costs | Request PDF CHW-delivered asthma programs have been demonstrated to be effective at decreasing pediatric asthma symptoms, asthma-related emergency ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6617892/

Effects of the home-based educational intervention on ... Moreover, the study's finding that a home-based asthma education program significantly improved the emotional health of families highlights the ...

7. nmhealth.org nmhealth.org/publication/view/report/3274/

New Mexico Asthma Control Program 2015 Pilot ... To evaluate the development, implementation, and outcomes associated with a new asthma home visiting program serving client families from a Federally Qualified ...

8. siumed.edu siumed.edu/sites/default/files/u971/impact_of_asthma_health_education_for_parents_of_children_attending_head_start.pdf

The Impact of Asthma Health Education for Parents of ... The purpose of this study was to test the effectiveness of an educational intervention based on the asthma and healthy homes curriculum targeting parents of ...

9. cdc.gov cdc.gov/pcd/issues/2020/19_0288.htm

Home Visits for Children With Asthma Reduce Medicaid ... Results showed significant improvements in asthma control, health care use, and environmental trigger reduction and a positive return on ...