Hospital to Home Study: Trial to Optimize Transitions and Address Disparities in Asthma Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hospital to Home Transition (H2H).
- Who it may be relevant to
- Registry conditions: Asthma, Asthma in Children. Basic parameters: 4 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Hospital to Home Study: A Pragmatic Trial to Optimize Transitions and Address Disparities in Asthma Care
Overview
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 mea
Primary outcome measures
- Number of Re-admissions [Time frame: 3, 6, 9, 12 months]
Secondary outcome measures (8)
- Number of Emergency Department (ED) Visit [Time frame: 3, 6, 9, 12 months]
- Asthma Control Test (ACT) [Time frame: 3, 6, 9, 12 months]
- Number of Household Triggers [Time frame: 3, 6, 9, 12 months]
- Caregiver quality of life [Time frame: 3 ,6, 9, 12 months]
- Symptom Free Days (SFD) [Time frame: 3, 6, 9, 12 months]
- Parent Self-Efficacy [Time frame: 3, 6, 9, 12 months]
- Caregiver Stress [Time frame: 3, 6, 9, 12 months]
- Parental Resilience [Time frame: 3, 6, 9, 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Children's National Hospital — Washington D.C.
Identifiers
NCT: NCT05991115 · STUDY0699