xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05991115</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY0699</org_study_id>
      <nct_id>NCT05991115</nct_id>
    </id_info>
    <brief_title>Hospital to Home Study: Trial to Optimize Transitions and Address Disparities in Asthma Care</brief_title>
    <official_title>The Hospital to Home Study: A Pragmatic Trial to Optimize Transitions and Address Disparities in Asthma Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kavita Parikh</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's National Research Institute</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Caregiver-child dyads will be recruited during child's hospital admission for asthma&#xD;
        exacerbation. Recruitment sites will be mainly Children's National Hospital Sheikh Zayed&#xD;
        campus, as well as regional partners: Holy Cross Hospital, and Mary Washington Hospital.&#xD;
        After enrollment, baseline data will be collected from caregiver. Caregiver-child dyads will&#xD;
        be randomized (1:1 ratio) into the control arm or intervention arm. Control arm will receive&#xD;
        the standard of care after hospital discharge. Intervention arm will receive the SOC plus an&#xD;
        asthma navigator support after hospital discharge. Caregivers in both arms will complete data&#xD;
        collection surveys (either in-person or via telehealth) at 3-,6-, 9-, and 12- month post&#xD;
        enrollment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">December 2027</completion_date>
    <primary_completion_date type="Anticipated">January 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Re-admissions</measure>
      <time_frame>3, 6, 9, 12 months</time_frame>
      <description>Asthma-related readmissions over 12-month follow-up period from index hospitalization</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Emergency Department (ED) Visit</measure>
      <time_frame>3, 6, 9, 12 months</time_frame>
      <description>Asthma-related ED visits over 12-month follow-up period from index hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Asthma Control Test (ACT)</measure>
      <time_frame>3, 6, 9, 12 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Household Triggers</measure>
      <time_frame>3, 6, 9, 12 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregiver quality of life</measure>
      <time_frame>3 ,6, 9, 12 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptom Free Days (SFD)</measure>
      <time_frame>3, 6, 9, 12 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parent Self-Efficacy</measure>
      <time_frame>3, 6, 9, 12 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregiver Stress</measure>
      <time_frame>3, 6, 9, 12 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental Resilience</measure>
      <time_frame>3, 6, 9, 12 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Sociodemographic factors</measure>
      <time_frame>Baseline</time_frame>
      <description>Age, Gender, Martial Status, Race, Ethnicity, Socioeconomic status, Occupation, Education, Household size, Number of asthma caregivers, English Proficiency, and Health Literacy</description>
    </other_outcome>
    <other_outcome>
      <measure>Experience with Discrimination (EOD)</measure>
      <time_frame>Baseline</time_frame>
      <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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Asthma severity</measure>
      <time_frame>Baseline</time_frame>
      <description>Asthma severity will be measured by NIH classification of Intermittent, Persistent mild, Persistent moderate, Persistent severe.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">340</enrollment>
    <condition>Asthma</condition>
    <condition>Asthma in Children</condition>
    <arm_group>
      <arm_group_label>Standard of Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Control arm will receive the standard of care (SOC) after hospital discharge.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Hospital to Home Transition (H2H)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Hospital to Home Transition (H2H)</intervention_name>
      <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.</description>
      <arm_group_label>Hospital to Home Transition (H2H)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. speak English or Spanish&#xD;
  &#xD;
            2. are at least 18 years old&#xD;
  &#xD;
            3. live in the District of Columbia, Maryland, or Virginia (DMV)&#xD;
  &#xD;
            4. have a child aged 4-12 years who is hospitalized due to asthma exacerbation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. . Children ages 4-12 years with chronic medical condition (other than asthma)&#xD;
               including but not limited to diabetes, sickle cell disease, heart disease, lung&#xD;
               disease or neurological disorder&#xD;
  &#xD;
            2. . Children ages 4-12 years involved in interventions with behavioral component and/or&#xD;
               novel asthma therapeutics will be excluded given overlap with the current intervention&#xD;
  &#xD;
            3. . Children ages 4-12 years in foster care&#xD;
  &#xD;
            4. . Families not residing in the DMV&#xD;
  &#xD;
            5. . Caregivers who do not speak English or Spanish&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kavita Parikh, MD MSHS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Children's National Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kavita Parikh, MD MSHS</last_name>
      <phone>2024766366</phone>
      <email>kparikh@childrensnational.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jordan Carter</last_name>
      <phone>2024763000</phone>
      <email>JCARTER1@childrensnational.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Children's National Research Institute</investigator_affiliation>
      <investigator_full_name>Kavita Parikh</investigator_full_name>
      <investigator_title>Associate Professor of Pediatrics</investigator_title>
    </responsible_party>
    <keyword>asthma</keyword>
    <keyword>hospitalization</keyword>
    <keyword>children</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05991115
  org study id: STUDY0699
  nct id: NCT05991115
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Number of Re-admissions
  time frame: 3, 6, 9, 12 months
  description: Asthma-related readmissions over 12-month follow-up period from index hospitalization
  measure: Number of Emergency Department (ED) Visit
  time frame: 3, 6, 9, 12 months
  description: Asthma-related ED visits over 12-month follow-up period from index hospitalization
  measure: Asthma Control Test (ACT)
  time frame: 3, 6, 9, 12 months
  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.
  measure: Number of Household Triggers
  time frame: 3, 6, 9, 12 months
  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.
  measure: Caregiver quality of life
  time frame: 3 ,6, 9, 12 months
  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.
  measure: Symptom Free Days (SFD)
  time frame: 3, 6, 9, 12 months
  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.
  measure: Parent Self-Efficacy
  time frame: 3, 6, 9, 12 months
  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.
  measure: Caregiver Stress
  time frame: 3, 6, 9, 12 months
  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.
  measure: Parental Resilience
  time frame: 3, 6, 9, 12 months
  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.
  measure: Sociodemographic factors
  time frame: Baseline
  description: Age, Gender, Martial Status, Race, Ethnicity, Socioeconomic status, Occupation, Education, Household size, Number of asthma caregivers, English Proficiency, and Health Literacy
  measure: Experience with Discrimination (EOD)
  time frame: Baseline
  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.
  measure: Asthma severity
  time frame: Baseline
  description: Asthma severity will be measured by NIH classification of Intermittent, Persistent mild, Persistent moderate, Persistent severe.
  arm group label: Standard of Care
  arm group type: No Intervention
  description: Control arm will receive the standard of care (SOC) after hospital discharge.
  arm group label: Hospital to Home Transition (H2H)
  arm group type: Experimental
  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: Hospital to Home Transition (H2H)
  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.
  arm group label: Hospital to Home Transition (H2H)
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Kavita Parikh, MD MSHS
  role: Principal Investigator
  affiliation: Children's National Research Institute
  last name: Kavita Parikh, MD MSHS
  phone: 2024766366
  email: kparikh@childrensnational.org
  last name: Jordan Carter
  phone: 2024763000
  email: JCARTER1@childrensnational.org
  responsible party type: Sponsor-Investigator
  investigator affiliation: Children's National Research Institute
  investigator full name: Kavita Parikh
  investigator title: Associate Professor of Pediatrics
  mesh term: Asthma