Back to resultsHospital to Home Study: Trial to Optimize Transitions and Address Disparities in Asthma Care
Primary Purpose
Asthma, Asthma in Children
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hospital to Home Transition (H2H)
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma, hospitalization, children
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
Hospital to Home Transition (H2H)
Arm Description
Control arm will receive the standard of care (SOC) after hospital discharge.
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.
Outcomes
Primary Outcome Measures
Number of Re-admissions
Asthma-related readmissions over 12-month follow-up period from index hospitalization
Secondary Outcome Measures
Number of Emergency Department (ED) Visit
Asthma-related ED visits over 12-month follow-up period from index hospitalization
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05991115
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kavita Parikh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Asthma in Children
Keywords
asthma, hospitalization, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
340 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Control arm will receive the standard of care (SOC) after hospital discharge.
Arm Title
Hospital to Home Transition (H2H)
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Hospital to Home Transition (H2H)
Intervention 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.
Primary Outcome Measure Information:
Title
Number of Re-admissions
Description
Asthma-related readmissions over 12-month follow-up period from index hospitalization
Time Frame
3, 6, 9, 12 months
Secondary Outcome Measure Information:
Title
Number of Emergency Department (ED) Visit
Description
Asthma-related ED visits over 12-month follow-up period from index hospitalization
Time Frame
3, 6, 9, 12 months
Title
Asthma Control Test (ACT)
Description
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.
Time Frame
3, 6, 9, 12 months
Title
Number of Household Triggers
Description
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.
Time Frame
3, 6, 9, 12 months
Title
Caregiver quality of life
Description
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.
Time Frame
3 ,6, 9, 12 months
Title
Symptom Free Days (SFD)
Description
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.
Time Frame
3, 6, 9, 12 months
Title
Parent Self-Efficacy
Description
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.
Time Frame
3, 6, 9, 12 months
Title
Caregiver Stress
Description
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.
Time Frame
3, 6, 9, 12 months
Title
Parental Resilience
Description
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.
Time Frame
3, 6, 9, 12 months
Other Pre-specified Outcome Measures:
Title
Sociodemographic factors
Description
Age, Gender, Martial Status, Race, Ethnicity, Socioeconomic status, Occupation, Education, Household size, Number of asthma caregivers, English Proficiency, and Health Literacy
Time Frame
Baseline
Title
Experience with Discrimination (EOD)
Description
Survey includes experiences with discrimination and situations of unfair treatment asking about frequency as well as the specific situation. Validated close-format questions used in diverse racial/ethnic groups.
Time Frame
Baseline
Title
Asthma severity
Description
Asthma severity will be measured by NIH classification of Intermittent, Persistent mild, Persistent moderate, Persistent severe.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kavita Parikh, MD MSHS
Phone
2024766366
Email
kparikh@childrensnational.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Carter
Phone
2024763000
Email
JCARTER1@childrensnational.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kavita Parikh, MD MSHS
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Hospital to Home Study: Trial to Optimize Transitions and Address Disparities in Asthma Care
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