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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Promotora Home Visit 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. Additionally, educational programs for asthma management have been shown to reduce asthma attacks and improve parents' understanding of the disease. ^{1 2 3 4 5}

How does the Promotora Home Visit treatment for childhood asthma differ from other treatments?

The Promotora Home Visit treatment is unique because it involves personalized home visits by trained community health workers who tailor asthma education and management strategies to the specific needs of each family in their home environment. This approach allows for cultural and language matching, reduces the burden on families, and helps maintain engagement over time, which is different from traditional clinic-based asthma care. ^{1 3 6 7 8}

Research Team

Julia Rosenberg, MD MHS

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Controlled trial of a home and ambulatory program for asthmatic children. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures for allergy and asthma in children. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Primary care provider perceptions of an asthma home visiting program. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Clinical effects of a Long-term Educational Program for children with asthma - Aironet. A 1-yr randomized controlled trial. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Risk factors for persistence of asthma in children: 10-year follow-up. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

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

8. Switzerland 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. [2020]