AsthmaH2HNCT05991115
Hospital to Home Study: Trial to Optimize Transitions and Address Disparities in Asthma Care
A study testing Hospital to Home Transition (H2H) in people with Asthma and Asthma in Children, run by Kavita Parikh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Asthma, Asthma in Children
- What is being tested?
- Hospital to Home Transition (H2H)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- . 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Kavita Parikh, MD, 2024766366, kparikh@childrensnational.org
Alicia Mattis, 2024764698, anewcome@childrensnational.org
About this study
Official title: The Hospital to Home Study: A Pragmatic Trial to Optimize Transitions and Address Disparities in Asthma Care
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
- Being tested
- Hospital to Home Transition (H2H)
- Keywords
- asthma, hospitalization, children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital to Home Transition (H2H)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Control arm will receive the standard of care (SOC) after hospital discharge. |
| Hospital to Home Transition (H2H) | Experimental | 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. Receives: Behavioral: Hospital to Home Transition (H2H) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Re-admissions
Asthma-related readmissions over 12-month follow-up period from index hospitalization
Measured: 3, 6, 9, 12 months
Secondary outcomes (8)
Number of Emergency Department (ED) Visit
Asthma-related ED visits over 12-month follow-up period from index hospitalization
Measured: 3, 6, 9, 12 months
Asthma Control Test (ACT)
Asthma Control Test (ACT) which is 7 questions with scores ranging from 0 to 27. Score less than 19 means that asthma is not well-controlled.
Measured: 3, 6, 9, 12 months
Number of Household Triggers
Questionnaire from home visit program. Includes exposures in the home, specifically: birds, cats, dogs, dust, eats in Bedroom, tobacco smoke, fireplace/wood burning stove/heat source, incense/candles, mice/rats, roaches/waterbugs, mold/mildew smell;water damage, perfume, other.
Measured: 3, 6, 9, 12 months
Caregiver quality of life
Pediatric Asthma Caregivers Quality of Life Questionnaire (PACQLQ) which includes 13-items; includes feelings about child's asthma symptoms (9 items), level of concern about child's asthma (4 items); uses a 7-point Likert scale.Responses to each item of the PACQLQ are given on a seven-point scale, ranging from 1 to 7, with the higher scores indicating less impairment. The result will be expressed as a mean score per item for each of the domains, as well as for the overall quality of life. Higher score means better outcome.
Measured: 3 ,6, 9, 12 months
Symptom Free Days (SFD)
Symptom Free Days (SFD) is measured over the last 14 days, and ranges from 0 to 14. SFD question will be asked at 3,6,9,12 month data collection with a 14 day look-back period.
Measured: 3, 6, 9, 12 months
Parent Self-Efficacy
Parent Asthma Management Self- Efficacy Scale (PAMES) survey includes 13-item questions that measures parent self-efficacy with child's asthma; uses a 5-point scale. Scores range from 13-65. Parents rated their responses on a 5-point ordinal scale from 1= not at all sure to 5 = completely sure. Higher score means better outcome.
Measured: 3, 6, 9, 12 months
Caregiver Stress
Perceived Stress Scale (PSS) is a validated tool with a shorter validated version that can be used for data collection over the phone and uses a 5-point ordinal scale. Individual scores on the PSS can range from 0 to 40 with higher score indicating higher perceived stress. Higher score means worse outcome.
Measured: 3, 6, 9, 12 months
Parental Resilience
Brief Resilience Scale (BRS) is 6-item tool to measure resilience or the ability to bounce back or recover from stress that would be valuable in coping with health-related stressors. Total score will range from 6-30. Higher score means better outcome.
Measured: 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start22 Jan 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kavita Parikh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kavita Parikh, Children's National Research Institute
- Investigators
- Kavita Parikh, MD MSHS, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991115
- Sponsor's protocol ID
- STUDY0699
- Acronym
- H2H
- Status last verified
- Mar 2026
- First submitted
- 26 Jul 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hospital to Home Study: A Pragmatic Trial to Optimize Transitions and Address Disparities in Asthma Care
- ClinicalTrials.gov ID
- NCT05991115
- Acronym / sponsor ID
- H2H / STUDY0699
- Conditions
- Asthma, Asthma in Children
- Keywords
- asthma, hospitalization, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Kavita ParikhUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Control arm will receive the standard of care (SOC) after hospital discharge. |
| Hospital to Home Transition (H2H) | Experimental | 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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- . 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Hospital to Home Transition (H2H) |
Primary outcome
Number of Re-admissions
Time frame: 3, 6, 9, 12 months
Asthma-related readmissions over 12-month follow-up period from index hospitalization
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kavita Parikh, MD MSHS principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital to Home Transition (H2H) in people with Asthma and Asthma in Children, run by Kavita Parikh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kavita Parikh, MD MSHS (2024766366, kparikh@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Re-admissions (time frame: 3, 6, 9, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.