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Hospital to Home Study: Trial to Optimize Transitions and Address Disparities in Asthma Care (H2H)

K

Kavita Parikh

Status

Enrolling

Conditions

Asthma
Asthma in Children

Treatments

Behavioral: Hospital to Home Transition (H2H)

Study type

Interventional

Funder types

Other

Identifiers

NCT05991115
STUDY0699

Details and patient eligibility

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. 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.

Enrollment

340 estimated patients

Sex

All

Ages

4 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

340 participants in 2 patient groups

Standard of Care
No Intervention group
Description:
Control arm will receive the standard of care (SOC) after hospital discharge.
Hospital to Home Transition (H2H)
Experimental group
Description:
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.
Treatment:
Behavioral: Hospital to Home Transition (H2H)

Trial contacts and locations

1

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Central trial contact

Kavita Parikh, MD MSHS; Alicia Mathis

Data sourced from clinicaltrials.gov

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