<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/NCT04470193</url>
  </required_header>
  <id_info>
    <org_study_id>088596</org_study_id>
    <nct_id>NCT04470193</nct_id>
  </id_info>
  <brief_title>Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial</brief_title>
  <official_title>Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HRSA/Maternal and Child Health Bureau</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</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>
      The investigators have developed a tool to facilitate self-management for children with&#xD;
      medical complexity (complex, multisystem chronic diseases) called MyChildCMC (My Child's&#xD;
      Complex Medical Condition). MyChildCMC is an online, phone application (app) that engages&#xD;
      parents daily in ongoing monitoring of common, crosscutting acute symptoms, including&#xD;
      respiratory distress, inadequate feeding/fluid intake, fever, altered mental status, pain,&#xD;
      and seizure status. The MyChildCMC app also guides parents to recognize early warning signs&#xD;
      for health deteriorations to avoid acute events (i.e., ED visits and/or hospitalizations).&#xD;
&#xD;
      Parent comments during the development of the MyChildCMC application revealed that the tool&#xD;
      had potential in helping them manage their child's chronic conditions. This study will be the&#xD;
      first to explore if online home monitoring using online technology is feasible, scalable, and&#xD;
      can lead to improved CMC outcomes. This pilot feasibility trial for the MyChildCMC app will&#xD;
      determine app feasibility and if successful, our approach will be a model for improving CMC&#xD;
      care and reducing costs for families and children with medical complexity. Future MyChildCMC&#xD;
      trials will integrate care coordination and a more robust alert system to help facilitate&#xD;
      care and follow-up for patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: Investigators will assess the impact of the MyChildCMC app by comparing outcomes for the&#xD;
      child and caregiver with the following outcomes:&#xD;
&#xD;
        1. Child Quality of Life (QOL)&#xD;
&#xD;
        2. Child Hospital and Emergency Department (ED) admissions&#xD;
&#xD;
        3. Parent/Caregiver satisfaction with care&#xD;
&#xD;
        4. Study participation rate&#xD;
&#xD;
        5. Retention of intervention (intervention arm only)&#xD;
&#xD;
        6. Adherence of intervention (intervention arm only)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2019</start_date>
  <completion_date type="Actual">March 19, 2020</completion_date>
  <primary_completion_date type="Actual">March 19, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Quality of Life (QOL)</measure>
    <time_frame>QUality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention</time_frame>
    <description>Compared Mean QOL Change from Baseline to Each Follow-up Assessment Between the Two Intervention Groups, using the QOL survey questionnaire for children with complex medical conditions (adapted from Ellzey et. al), which assesses multiple domains including physical health, mental health, sleep, pain, activities and general QOL.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Emergency Department (ED)/Hospitalization</measure>
    <time_frame>Change in ED/hospital admission between 3-month prior and 3-month post start of study/intervention</time_frame>
    <description>Compare NUMBER of ED and hospital admissions, 3-month prior the study intervention and 3-month post start of the study intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent/Caregiver Satisfaction with Care</measure>
    <time_frame>Collected once at study end (3 months)</time_frame>
    <description>Caregiver Satisfaction with overall care of their children, using satisfaction survey questionnaire for children with complex medical conditions (published by Ellzey et. al), which measure, caregiver's confidence with ability to take care of child's health, consistency in doing things needed to take care of the child, availability of medical professional support, availability of social support, availability of a monitory system to help with child's home care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study Participation Rate</measure>
    <time_frame>Collected once at study end (3 months)</time_frame>
    <description>Percentage of eligible subjects who agreed to participate out of those who were approached</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient retention to intervention (intervention arm only)</measure>
    <time_frame>Collected at 1 month and 3 months</time_frame>
    <description>Percentage of patient/parents in the intervention arm who completed the final QOL or vitals assessment during the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient adherence to intervention (intervention arm only)</measure>
    <time_frame>Collected at 1 month and 3 months</time_frame>
    <description>Percentage of daily vital signs/symptoms recorded over the 3 month period out of all opportunities</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Children With Medical Complexity</condition>
  <arm_group>
    <arm_group_label>MyChildCMC Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parents/patients randomized into the MyChildCMC Intervention Group will use the MyChildCMC app to monitor their child's daily symptoms for the duration of the study period (3 months). The MyChildCMC app includes a daily form consisting of 12 questions assessing child's vitals, pain, seizures, mood, and feeding as well as caregiver worry for the day. Daily reminders are sent to the parent to fill out the vitals form in the app. Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Parents/patients randomized into the Standard of Care Group do not use the MyChildCMC app to monitor their child's daily symptoms and are instructed to continue with regular care for their child and to continue monitoring their child's symptoms on their own without the use of the app for the duration of the study period (3 months). Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MyChildCMC app</intervention_name>
    <description>Patients/parents will self-monitor their symptoms daily using the MyChildCMC app completing the daily vitals form. After patient/parents complete the daily form, the app provides in-app alerts and graphs showing symptom data over time.</description>
    <arm_group_label>MyChildCMC Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Participant Inclusion Criteria:&#xD;
&#xD;
        Children with complex medical conditions* ages 1 through 20 years with their primary&#xD;
        caregiver (primary person caring for the child) who:&#xD;
&#xD;
          -  have been seen at Primary Children's Hospital within 365 days,&#xD;
&#xD;
          -  own a smartphone or a tablet computer with Internet access, and&#xD;
&#xD;
          -  are English speaking *Physician diagnosis wa used to determine CMC diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Critically ill children in imminent death&#xD;
&#xD;
          -  Non-English speakers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Flory Nkoy, MD, MS, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kogan MD, Strickland BB, Newacheck PW. Building systems of care: findings from the National Survey of Children With Special Health Care Needs. Pediatrics. 2009 Dec;124 Suppl 4:S333-6. doi: 10.1542/peds.2009-1255B. No abstract available.</citation>
    <PMID>19948596</PMID>
  </reference>
  <reference>
    <citation>McPherson M, Arango P, Fox H, Lauver C, McManus M, Newacheck PW, Perrin JM, Shonkoff JP, Strickland B. A new definition of children with special health care needs. Pediatrics. 1998 Jul;102(1 Pt 1):137-40. doi: 10.1542/peds.102.1.137. No abstract available.</citation>
    <PMID>9714637</PMID>
  </reference>
  <reference>
    <citation>Newacheck PW, Strickland B, Shonkoff JP, Perrin JM, McPherson M, McManus M, Lauver C, Fox H, Arango P. An epidemiologic profile of children with special health care needs. Pediatrics. 1998 Jul;102(1 Pt 1):117-23. doi: 10.1542/peds.102.1.117.</citation>
    <PMID>9651423</PMID>
  </reference>
  <reference>
    <citation>Strickland B, McPherson M, Weissman G, van Dyck P, Huang ZJ, Newacheck P. Access to the medical home: results of the National Survey of Children with Special Health Care Needs. Pediatrics. 2004 May;113(5 Suppl):1485-92.</citation>
    <PMID>15121916</PMID>
  </reference>
  <reference>
    <citation>Cohen E, Berry JG, Camacho X, Anderson G, Wodchis W, Guttmann A. Patterns and costs of health care use of children with medical complexity. Pediatrics. 2012 Dec;130(6):e1463-70. doi: 10.1542/peds.2012-0175. Epub 2012 Nov 26.</citation>
    <PMID>23184117</PMID>
  </reference>
  <reference>
    <citation>Feudtner C, Villareale NL, Morray B, Sharp V, Hays RM, Neff JM. Technology-dependency among patients discharged from a children's hospital: a retrospective cohort study. BMC Pediatr. 2005 May 9;5(1):8. doi: 10.1186/1471-2431-5-8.</citation>
    <PMID>15882452</PMID>
  </reference>
  <reference>
    <citation>Dolk H, Parkes J, Hill N. Trends in the prevalence of cerebral palsy in Northern Ireland, 1981-1997. Dev Med Child Neurol. 2006 Jun;48(6):406-12; discussion 405. doi: 10.1017/S0012162206000909.</citation>
    <PMID>16700928</PMID>
  </reference>
  <reference>
    <citation>Farooqi A, Hagglof B, Sedin G, Gothefors L, Serenius F. Chronic conditions, functional limitations, and special health care needs in 10- to 12-year-old children born at 23 to 25 weeks' gestation in the 1990s: a Swedish national prospective follow-up study. Pediatrics. 2006 Nov;118(5):e1466-77. doi: 10.1542/peds.2006-1070.</citation>
    <PMID>17079547</PMID>
  </reference>
  <reference>
    <citation>Association CsH. Optimizing Health Care for Children with Medical Complexity Annual Report 2013:2.</citation>
  </reference>
  <reference>
    <citation>Vestal C. Improving Medicaid for 'Medically Complex' Kids. The Pew Charitable Trusts 2015;January 08.</citation>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Flory Nkoy</investigator_full_name>
    <investigator_title>Research Professor</investigator_title>
  </responsible_party>
  <keyword>medical complexity</keyword>
  <keyword>multiple chronic conditions</keyword>
  <keyword>children</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 9, 2021</submitted>
    <returned>July 29, 2021</returned>
    <submitted>May 27, 2022</submitted>
    <returned>March 6, 2023</returned>
    <submitted>March 6, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04470193
org study id: 088596
nct id: NCT04470193
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators have developed a tool to facilitate self-management for children with
      medical complexity (complex, multisystem chronic diseases) called MyChildCMC (My Child's
      Complex Medical Condition). MyChildCMC is an online, phone application (app) that engages
      parents daily in ongoing monitoring of common, crosscutting acute symptoms, including
      respiratory distress, inadequate feeding/fluid intake, fever, altered mental status, pain,
      and seizure status. The MyChildCMC app also guides parents to recognize early warning signs
      for health deteriorations to avoid acute events (i.e., ED visits and/or hospitalizations).

      Parent comments during the development of the MyChildCMC application revealed that the tool
      had potential in helping them manage their child's chronic conditions. This study will be the
      first to explore if online home monitoring using online technology is feasible, scalable, and
      can lead to improved CMC outcomes. This pilot feasibility trial for the MyChildCMC app will
      determine app feasibility and if successful, our approach will be a model for improving CMC
      care and reducing costs for families and children with medical complexity. Future MyChildCMC
      trials will integrate care coordination and a more robust alert system to help facilitate
      care and follow-up for patients.
Aim: Investigators will assess the impact of the MyChildCMC app by comparing outcomes for the
      child and caregiver with the following outcomes:

        1. Child Quality of Life (QOL)

        2. Child Hospital and Emergency Department (ED) admissions

        3. Parent/Caregiver satisfaction with care

        4. Study participation rate

        5. Retention of intervention (intervention arm only)

        6. Adherence of intervention (intervention arm only)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Patient Quality of Life (QOL)
time frame: QUality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention
description: Compared Mean QOL Change from Baseline to Each Follow-up Assessment Between the Two Intervention Groups, using the QOL survey questionnaire for children with complex medical conditions (adapted from Ellzey et. al), which assesses multiple domains including physical health, mental health, sleep, pain, activities and general QOL.
measure: Patient Emergency Department (ED)/Hospitalization
time frame: Change in ED/hospital admission between 3-month prior and 3-month post start of study/intervention
description: Compare NUMBER of ED and hospital admissions, 3-month prior the study intervention and 3-month post start of the study intervention.
measure: Parent/Caregiver Satisfaction with Care
time frame: Collected once at study end (3 months)
description: Caregiver Satisfaction with overall care of their children, using satisfaction survey questionnaire for children with complex medical conditions (published by Ellzey et. al), which measure, caregiver's confidence with ability to take care of child's health, consistency in doing things needed to take care of the child, availability of medical professional support, availability of social support, availability of a monitory system to help with child's home care.
measure: Study Participation Rate
time frame: Collected once at study end (3 months)
description: Percentage of eligible subjects who agreed to participate out of those who were approached
measure: Patient retention to intervention (intervention arm only)
time frame: Collected at 1 month and 3 months
description: Percentage of patient/parents in the intervention arm who completed the final QOL or vitals assessment during the study period
measure: Patient adherence to intervention (intervention arm only)
time frame: Collected at 1 month and 3 months
description: Percentage of daily vital signs/symptoms recorded over the 3 month period out of all opportunities
arm group label: MyChildCMC Intervention Group
arm group type: Experimental
description: Parents/patients randomized into the MyChildCMC Intervention Group will use the MyChildCMC app to monitor their child's daily symptoms for the duration of the study period (3 months). The MyChildCMC app includes a daily form consisting of 12 questions assessing child's vitals, pain, seizures, mood, and feeding as well as caregiver worry for the day. Daily reminders are sent to the parent to fill out the vitals form in the app. Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
arm group label: Standard of Care Group
arm group type: No Intervention
description: Parents/patients randomized into the Standard of Care Group do not use the MyChildCMC app to monitor their child's daily symptoms and are instructed to continue with regular care for their child and to continue monitoring their child's symptoms on their own without the use of the app for the duration of the study period (3 months). Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
intervention type: Other
intervention name: MyChildCMC app
description: Patients/parents will self-monitor their symptoms daily using the MyChildCMC app completing the daily vitals form. After patient/parents complete the daily form, the app provides in-app alerts and graphs showing symptom data over time.
arm group label: MyChildCMC Intervention Group
criteria: 
gender: All
minimum age: 1 Year
maximum age: 20 Years
healthy volunteers: No
last name: Flory Nkoy, MD, MS, MPH
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
citation: Kogan MD, Strickland BB, Newacheck PW. Building systems of care: findings from the National Survey of Children With Special Health Care Needs. Pediatrics. 2009 Dec;124 Suppl 4:S333-6. doi: 10.1542/peds.2009-1255B. No abstract available.
PMID: 19948596
citation: McPherson M, Arango P, Fox H, Lauver C, McManus M, Newacheck PW, Perrin JM, Shonkoff JP, Strickland B. A new definition of children with special health care needs. Pediatrics. 1998 Jul;102(1 Pt 1):137-40. doi: 10.1542/peds.102.1.137. No abstract available.
PMID: 9714637
citation: Newacheck PW, Strickland B, Shonkoff JP, Perrin JM, McPherson M, McManus M, Lauver C, Fox H, Arango P. An epidemiologic profile of children with special health care needs. Pediatrics. 1998 Jul;102(1 Pt 1):117-23. doi: 10.1542/peds.102.1.117.
PMID: 9651423
citation: Strickland B, McPherson M, Weissman G, van Dyck P, Huang ZJ, Newacheck P. Access to the medical home: results of the National Survey of Children with Special Health Care Needs. Pediatrics. 2004 May;113(5 Suppl):1485-92.
PMID: 15121916
citation: Cohen E, Berry JG, Camacho X, Anderson G, Wodchis W, Guttmann A. Patterns and costs of health care use of children with medical complexity. Pediatrics. 2012 Dec;130(6):e1463-70. doi: 10.1542/peds.2012-0175. Epub 2012 Nov 26.
PMID: 23184117
citation: Feudtner C, Villareale NL, Morray B, Sharp V, Hays RM, Neff JM. Technology-dependency among patients discharged from a children's hospital: a retrospective cohort study. BMC Pediatr. 2005 May 9;5(1):8. doi: 10.1186/1471-2431-5-8.
PMID: 15882452
citation: Dolk H, Parkes J, Hill N. Trends in the prevalence of cerebral palsy in Northern Ireland, 1981-1997. Dev Med Child Neurol. 2006 Jun;48(6):406-12; discussion 405. doi: 10.1017/S0012162206000909.
PMID: 16700928
citation: Farooqi A, Hagglof B, Sedin G, Gothefors L, Serenius F. Chronic conditions, functional limitations, and special health care needs in 10- to 12-year-old children born at 23 to 25 weeks' gestation in the 1990s: a Swedish national prospective follow-up study. Pediatrics. 2006 Nov;118(5):e1466-77. doi: 10.1542/peds.2006-1070.
PMID: 17079547
citation: Association CsH. Optimizing Health Care for Children with Medical Complexity Annual Report 2013:2.
citation: Vestal C. Improving Medicaid for 'Medically Complex' Kids. The Pew Charitable Trusts 2015;January 08.
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Flory Nkoy
investigator title: Research Professor
sharing ipd: No
submitted: July 9, 2021
returned: July 29, 2021
submitted: May 27, 2022
returned: March 6, 2023
submitted: March 6, 2023