NCT05991115 · Kavita Parikh
Hospital to Home Study: Trial to Optimize Transitions and Address Disparities in Asthma Care
(H2H)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Number of Re-admissions
Time frame: 3, 6, 9, 12 months
Asthma-related readmissions over 12-month follow-up period from index hospitalization
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- speak English or Spanish
- are at least 18 years old
- live in the District of Columbia, Maryland, or Virginia (DMV)
- have a child aged 4-12 years who is hospitalized due to asthma exacerbation.
Exclusion criteria
- . 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
- . 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
- . Children ages 4-12 years in foster care
- . Families not residing in the DMV
- . Caregivers who do not speak English or Spanish
Where
- Washington D.C., District of Columbia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 17, 2026 · Source of record for eligibility and locations