Clinical trial NCT05991115: Hospital to Home Study: Trial to Optimize Transitions and Address Disparities in Asthma Care
Official title: The Hospital to Home Study: a Pragmatic Trial to Optimize Transitions and Address Disparities in Asthma Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Asthma in Children
Keywords: asthma
hospitalization
children
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 340
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Re-admissions
timeFrame: 3, 6, 9, 12 months
Secondary outcomes:
measure: Number of Emergency Department (ED) Visit
timeFrame: 3, 6, 9, 12 months
measure: Asthma Control Test (ACT)
timeFrame: 3, 6, 9, 12 months
measure: Number of Household Triggers
timeFrame: 3, 6, 9, 12 months
measure: Caregiver quality of life
timeFrame: 3 ,6, 9, 12 months
measure: Symptom Free Days (SFD)
timeFrame: 3, 6, 9, 12 months
measure: Parent Self-Efficacy
timeFrame: 3, 6, 9, 12 months
measure: Caregiver Stress
timeFrame: 3, 6, 9, 12 months
measure: Parental Resilience
timeFrame: 3, 6, 9, 12 months
Other outcomes:
measure: Sociodemographic factors
timeFrame: Baseline
measure: Experience with Discrimination (EOD)
timeFrame: Baseline
measure: Asthma severity
timeFrame: Baseline
Locations:
city: Washington DC
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Kavita Parikh, MD MSHS
role: PRINCIPAL_INVESTIGATOR
References: