Recruiting

Asthma Care

Sponsor:

Kavita Parikh

Code:

NCT05991115

Conditions

Asthma

Asthma in Children

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

Interventions

Hospital to Home Transition (H2H)

Study Details

Brief summary:

Caregiver-child dyads will be recruited during child's hospital admission for asthma exacerbation. Recruitment sites will be mainly Children's National Hospital Sheikh Zayed campus, as well as regional partners: Holy Cross Hospital, and Mary Washington Hospital. After enrollment, baseline data will be collected from caregiver. Caregiver-child dyads will be randomized (1:1 ratio) into the control arm or intervention arm. Control arm will receive the standard of care after hospital discharge. Intervention arm will receive the SOC plus an asthma navigator support after hospital discharge. Caregivers in both arms will complete data collection surveys (either in-person or via telehealth) at 3-,6-, 9-, and 12- month post enrollment.

Conditions

Asthma

Asthma in Children

Study ID

NCT05991115

Start date

Jan 22, 2024

Status verified date

Mar, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. speak English or Spanish
2. are at least 18 years old
3. live in the District of Columbia, Maryland, or Virginia (DMV)
4. have a child aged 4-12 years who is hospitalized due to asthma exacerbation.

Exclusion Criteria:

1. . Children ages 4-12 years with chronic medical condition (other than asthma) including but not limited to diabetes, sickle cell disease, heart disease, lung disease or neurological disorder
2. . Children ages 4-12 years involved in interventions with behavioral component and/or novel asthma therapeutics will be excluded given overlap with the current intervention
3. . Children ages 4-12 years in foster care
4. . Families not residing in the DMV
5. . Caregivers who do not speak English or Spanish

Study Design

Enrollment

340 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of Care

Control arm will receive the standard of care (SOC) after hospital discharge.

experimental: Hospital to Home Transition (H2H)

The intervention for this study is a multi-component navigation-supported intervention for children hospitalized with asthma. Navigators will work with families for 12-months post-discharge. Trained asthma educator/navigators will work to address challenges with asthma care after discharge; will include maximum 15 contacts/12 months. The asthma navigators within this study will attempt to maintain direct contact with participants primary care doctors through email, fax, and/or postal mail as means for delivering asthma action plans, prescription updates, and patient appointment scheduling. The asthma navigators for intervention participants will attempt to maintain contact with the school nurse in efforts to have a line of communication with the school. Asthma navigators will assist families in all home-based needs pertaining to their child's asthma.

Interventions

Hospital to Home Transition (H2H)

The intervention for this study is a multi-component navigation-supported intervention for children hospitalized with asthma. Navigators will work with families for 12-months post-discharge. Trained asthma educator/navigators will work to address challenges with asthma care after discharge; will include maximum 15 contacts/12 months. The asthma navigators within this study will attempt to maintain direct contact with participants primary care doctors through email, fax, and/or postal mail as means for delivering asthma action plans, prescription updates, and patient appointment scheduling. The asthma navigators for intervention participants will attempt to maintain contact with the school nurse in efforts to have a line of communication with the school. Asthma navigators will assist families in all home-based needs pertaining to their child's asthma.

Primary outcome measure

  • Number of Re-admissions [ Time Frame: 3, 6, 9, 12 months ]

Central Contacts and Locations

Central contacts

Kavita Parikh, MD MSHS

2024766366kparikh@childrensnational.org

Alicia Mathis

2024764698anewcome@childrensnational.org

Locations

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Kavita Parikh, MD

2024766366kparikh@childrensnational.org

Alicia Mattis

2024764698anewcome@childrensnational.org

More Information

Sponsor

Kavita Parikh

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • asthma
  • hospitalization
  • children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kavita Parikh on 2026-03-17.