<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/NCT03231020</url>
  </required_header>
  <id_info>
    <org_study_id>17050339</org_study_id>
    <nct_id>NCT03231020</nct_id>
  </id_info>
  <brief_title>Parental Experience in the Single Ventricle Interstage Utilizing a mHealth Innovation: A Comparative Case Study</brief_title>
  <official_title>Parental Experience in the Single Ventricle Interstage Utilizing a mHealth Innovation: A Comparative Case Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Mercy Hospital Kansas City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Nurse Credentialing Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Mercy Hospital Kansas City</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 purpose of this study is to provide a rich description of the parental perspectives of&#xD;
      utilizing a mHealth application for data transfer during the single ventricle interstage&#xD;
      monitoring period. A gap in the body of knowledge of single ventricle cardiac disease&#xD;
      interstage will be explored with these research questions: 1) How do parents of children (&lt; 5&#xD;
      years of age) with single ventricle disease describe their experiences using a mHealth&#xD;
      application during the interstage period (first 6-12 months of child's life)? And 2) How do&#xD;
      these experiences influence their decision making for use of the mHealth application?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Nearly 2,000 infants with single ventricle cardiac disease are born each year in&#xD;
      the United States, and have near certain mortality without surgical intervention. The heart&#xD;
      with this congenital disease can never be converted to a four-chambered heart but rather, a&#xD;
      palliative three-staged surgical strategy has been designed to maintain both circulation to&#xD;
      the body and lungs without a pump. After an initial neonatal surgery, most infants are&#xD;
      discharged home and return for a second surgery around six months of life. The time occurring&#xD;
      between surgeries is known as the interstage period. This interstage period is very high risk&#xD;
      and high demand time for parents, and there is a mortality rate during the interstage ranging&#xD;
      from 2-20%, often from unknown reasons.&#xD;
&#xD;
      Hypoplastic left heart syndrome (HLHS) is a specific type of single ventricle disease that is&#xD;
      one of the most complex forms of congenital heart disease. Publications have focused on&#xD;
      improving the care of infants with HLHS using a Quality Improvement Model with the National&#xD;
      Pediatric Cardiology Quality Improvement Collaborative (NPCQIC) through reduced variation,&#xD;
      best practices, and transparency. The concept of interstage home monitoring to reduce&#xD;
      mortality also was primarily focused on infants with only HLHS until recently when the focus&#xD;
      was made onto comprehensive care from birth to 1 year of age. Hemodynamic data such as oxygen&#xD;
      saturation, heart rate, intake, and overall status from a parental perspective were used to&#xD;
      promote communication and attempts of early recognition of deterioration in this high-risk&#xD;
      population. A strong set of qualitative studies have come from Rempel et al. in Canada on a&#xD;
      cross-section of mainly white married parents of infants with HLHS and their parenting&#xD;
      experience. Parenting under Pressure and the Facets of parenting a child with HLHS were&#xD;
      studies which used the grounded theory approach and provided substantial additions to our&#xD;
      knowledge of the interstage HLHS parenting experience. The basis of much of the care for all&#xD;
      types of single ventricle cardiac disease at home is found from the care of HLHS and applied&#xD;
      to infants with all types of single ventricle anatomy.&#xD;
&#xD;
      Most hospitals with pediatric cardiac surgery programs have interstage home monitoring&#xD;
      programs for high risk infants with single ventricle heart disease to provide care and&#xD;
      support for infants with all types of single ventricle cardiac disease. Education for&#xD;
      caregivers of infants with single ventricle disease include guidelines to call health care&#xD;
      providers (HCPs) in cases of hemodynamic interstage concerns, and symptom management&#xD;
      questions, based on home monitoring of oxygen saturation and weight gain. There are&#xD;
      variations in the staffing structure between pediatric hospitals but the programs often&#xD;
      include care coordination and education by a nurse or advanced practice nurse communicating&#xD;
      with parents in a reactive model waiting for data to be reported.&#xD;
&#xD;
      mHealth is defined through the National Institutes of Health (NIH) as the use of mobile and&#xD;
      wireless devices to improve health outcomes, service, and research. The use of applications&#xD;
      is widespread in adult care with estimated 40,000 health-care applications available. Some&#xD;
      studies in pediatric medical homes have shown association of mHealth with adherence and&#xD;
      self-monitoring to improved outcomes. mHealth innovations like the Cardiac High Acuity&#xD;
      Monitoring Program (CHAMP) and other applications work most effectively when caregivers and&#xD;
      interstage programs work together to improve care and are a focus of future research from the&#xD;
      National Institute of Nursing Research. Much of the recent interstage literature focuses on&#xD;
      mortality and weight measures with little focus on expanding types of outcomes to the&#xD;
      parental and interstage teams' perspectives and phenomena like infant development.&#xD;
&#xD;
      Recent developments in technology can provide a proactive means for data transfer for home&#xD;
      symptom monitoring so the interstage nursing team can review trends and provide proactive&#xD;
      monitoring for infants in the interstage. Since 2012, two pilot studies have been published&#xD;
      illustrating varying types of mHealth for the interstage with outcomes of improved somatic&#xD;
      growth and an improved system of interstage data review but did not show significant&#xD;
      mortality improvements. An innovative mHealth technology, CHAMP, was begun in 2014 for&#xD;
      interstage home monitoring symptom management and found improved interstage mortality&#xD;
      outcomes compared with historical controls. Research gaps remain in the role of adherence in&#xD;
      this population to the mHealth technology and the parental experience of utilizing these&#xD;
      innovative methods for communication with the clinical team.&#xD;
&#xD;
      Rationale The purpose of this study is to provide a rich description of the parental&#xD;
      perspectives of utilizing a mHealth application for data transfer during the single ventricle&#xD;
      interstage monitoring period for infants with congenital heart disease. The use of the case&#xD;
      study design in healthcare has been encouraged by Robert Yin because it adapts to the&#xD;
      complexity of interactions in a system that may be rapidly changing. Yin's qualitative case&#xD;
      research &quot;design propositions&quot;, presented below for this study, are applied to the literature&#xD;
      and the PI's professional experience to focus the scope of the study and improve feasibility&#xD;
      of completion of this qualitative case study approach research study. Propositions in this&#xD;
      type of qualitative design are similar to hypothesis in quantitative designs to help&#xD;
      formulate themes emerging from the data. The use of propositions may help with contributions&#xD;
      for the body of knowledge after generalizing case study analysis, especially in cases of&#xD;
      critical or extreme cases. Comparative analysis of the theoretical target (non-adherent&#xD;
      parents) and rival cases (adherent parents) within the case study are improved with study&#xD;
      propositions to guide the organization of data.&#xD;
&#xD;
      Study Propositions:&#xD;
&#xD;
        1. The parental perspectives of the interstage period will influence the use of a home&#xD;
           monitoring mHealth technology&#xD;
&#xD;
        2. Parental perception of non-adherence of CHAMP and communication to the clinical team&#xD;
           will match the actual non-adherence patterns of the mHealth innovation&#xD;
&#xD;
        3. The use of Cardiac High Acuity Monitoring Program (CHAMP) application from the parental&#xD;
           perspective will benefit future improvements in this technology&#xD;
&#xD;
        4. Parents of infants with single ventricle will report the interstage report as a&#xD;
           stressful time&#xD;
&#xD;
      Research Design&#xD;
&#xD;
      Methods. The proposed research study uses a comparative case study methodology, utilizing&#xD;
      multiple sources of data to deeply examine 8-10 &quot;cases,&quot; each of which is defined as&#xD;
      parent(s) of a child (&lt; 5 years of age) with single ventricle disease who used the mHealth&#xD;
      application. One group of cases (4-5) will have used the mHealth application less than&#xD;
      recommended (non-adherent to the home monitoring recommendations) or declined to use the&#xD;
      application and returned it before the end of the interstage period. The other group of&#xD;
      comparison cases (4-5 cases) will have used the application as recommended by the clinical&#xD;
      team (adherent) and continued doing so through the interstage period.&#xD;
&#xD;
      Yin defines various types of cases, including, explanatory or causal case studies,&#xD;
      descriptive case studies, and exploratory case studies. The cases in this study are&#xD;
      exploratory in that they focus on &quot;what&quot; can be learned from these cases of using a novel&#xD;
      mHealth innovation and the CHAMP care team as a unit. Across the U.S., nearly 2,000 infants&#xD;
      are born with single ventricle cardiac disease each year but the actual experience at home is&#xD;
      difficult to comprehend. The research design is a multiple case study design with embedded&#xD;
      units of non-adherent and adherent cases of parental use of CHAMP within the larger case&#xD;
      group through the CHAMP Clinic at Children's Mercy Kansas City.&#xD;
&#xD;
      Data sources will include semi-structured interviews with parents that include observations&#xD;
      of simulated home monitoring equipment and processes that had been previously used including&#xD;
      location, time of day, and frequency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2019</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 26, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to technology</measure>
    <time_frame>6 months</time_frame>
    <description>parental perspective on interstage period will influence the number of Data days during the interstage period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non-adherence to mHealth technology</measure>
    <time_frame>6 months</time_frame>
    <description>Parental perception of non-adherence of mHealth (CHAMP) and communication to the clinical team will match the actual non-adherence patterns of the mHealth innovation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Stress</measure>
    <time_frame>6 months</time_frame>
    <description>Parents of infants with single ventricle will report the interstage report as a stressful time</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">11</enrollment>
  <condition>mHealth</condition>
  <condition>Adherence, Patient</condition>
  <arm_group>
    <arm_group_label>Adherent Group</arm_group_label>
    <description>Parent(s) that submitted a high rate of data transfer (top 25th percentile) with rate of data days of mHealth technology for data transfer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Adherent Group</arm_group_label>
    <description>Parent(s) that chose to return mHealth technology before the end of the interstage period and/or low rate of data transfer (bottom 25th percentile) with rate of data days</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interview</intervention_name>
    <description>The proposed research study uses a comparative case study methodology, utilizing multiple sources of data to deeply examine 8-10 &quot;cases,&quot; each of which is defined as parent(s) of a child (&lt; 5 years of age) with single ventricle disease who used the mHealth application. One group of cases (4-5) will have used the mHealth application less than recommended (non-adherent to the home monitoring recommendations) or declined to use the application and returned it before the end of the interstage period. The other group of comparison cases (4-5 cases) will have used the application as recommended by the clinical team (adherent) and continued doing so through the interstage period.</description>
    <arm_group_label>Adherent Group</arm_group_label>
    <arm_group_label>Non-Adherent Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Purposeful sampling will be used for recruiting among the first 80 infants from that used&#xD;
        Cardiac High Acuity Monitoring Program (CHAMP) mHealth. All single and dual parent case&#xD;
        sets will be recruited from a single tertiary center's pediatric cardiology department that&#xD;
        used a mHealth application during the interstage period with the single ventricle team&#xD;
        clinic known as CHAMP. Thus a case will be defined as the parent(s) of a single ventricle&#xD;
        child who utilized CHAMP to monitor their baby at home during interstage with preliminary&#xD;
        screening from the CHAMP Webportal through Children's Mercy Kansas City.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult over 18 years of age parent(s) of children with single ventricle cardiac disease&#xD;
&#xD;
          2. Parent(s) of children were discharge home in the interstage period from December 2013&#xD;
             to May 2017 that have completed the interstage period with Stage II Glenn cardiac&#xD;
             surgery as of June 8th, 2017.&#xD;
&#xD;
          3. Parents(s) of children who were followed in the CHAMP clinic at Children's Mercy.&#xD;
&#xD;
          4. Parent(s) of CHAMP children who had the CHAMP mHealth application (CHAMP App)&#xD;
             available for transfer of home monitoring data during the interstage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non-English speaking parent(s)&#xD;
&#xD;
          2. Parent(s) of children who were not discharged interstage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori Erickson, MSN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Mercy Kansas City</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Mercy Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Shirali G, Erickson L, Apperson J, Goggin K, Williams D, Reid K, Bradley-Ewing A, Tucker D, Bingler M, Spertus J, Rabbitt L, Stroup R. Harnessing Teams and Technology to Improve Outcomes in Infants With Single Ventricle. Circ Cardiovasc Qual Outcomes. 2016 May;9(3):303-11. doi: 10.1161/CIRCOUTCOMES.115.002452. Epub 2016 May 10.</citation>
    <PMID>27166202</PMID>
  </reference>
  <reference>
    <citation>Yin RK. Enhancing the quality of case studies in health services research. Health Serv Res. 1999 Dec;34(5 Pt 2):1209-24.</citation>
    <PMID>10591280</PMID>
  </reference>
  <reference>
    <citation>Black AK, Sadanala UK, Mascio CE, Hornung CA, Keller BB. Challenges in implementing a pediatric cardiovascular home telehealth project. Telemed J E Health. 2014 Sep;20(9):858-67. doi: 10.1089/tmj.2013.0343. Epub 2014 Aug 1.</citation>
    <PMID>25083905</PMID>
  </reference>
  <reference>
    <citation>Rempel GR, Harrison MJ. Safeguarding precarious survival: parenting children who have life-threatening heart disease. Qual Health Res. 2007 Jul;17(6):824-37. doi: 10.1177/1049732307303164.</citation>
    <PMID>17582024</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
    <investigator_full_name>Lori Erickson</investigator_full_name>
    <investigator_title>CHAMP Clinical Program Manager, MSN, CPNP-PC</investigator_title>
  </responsible_party>
  <keyword>single ventricle</keyword>
  <keyword>pediatric cardiology</keyword>
  <keyword>interstage</keyword>
  <keyword>home monitoring</keyword>
  <keyword>mHealth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Univentricular Heart</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03231020
org study id: 17050339
nct id: NCT03231020
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to provide a rich description of the parental perspectives of
      utilizing a mHealth application for data transfer during the single ventricle interstage
      monitoring period. A gap in the body of knowledge of single ventricle cardiac disease
      interstage will be explored with these research questions: 1) How do parents of children (< 5
      years of age) with single ventricle disease describe their experiences using a mHealth
      application during the interstage period (first 6-12 months of child's life)? And 2) How do
      these experiences influence their decision making for use of the mHealth application?
Background Nearly 2,000 infants with single ventricle cardiac disease are born each year in
      the United States, and have near certain mortality without surgical intervention. The heart
      with this congenital disease can never be converted to a four-chambered heart but rather, a
      palliative three-staged surgical strategy has been designed to maintain both circulation to
      the body and lungs without a pump. After an initial neonatal surgery, most infants are
      discharged home and return for a second surgery around six months of life. The time occurring
      between surgeries is known as the interstage period. This interstage period is very high risk
      and high demand time for parents, and there is a mortality rate during the interstage ranging
      from 2-20%, often from unknown reasons.

      Hypoplastic left heart syndrome (HLHS) is a specific type of single ventricle disease that is
      one of the most complex forms of congenital heart disease. Publications have focused on
      improving the care of infants with HLHS using a Quality Improvement Model with the National
      Pediatric Cardiology Quality Improvement Collaborative (NPCQIC) through reduced variation,
      best practices, and transparency. The concept of interstage home monitoring to reduce
      mortality also was primarily focused on infants with only HLHS until recently when the focus
      was made onto comprehensive care from birth to 1 year of age. Hemodynamic data such as oxygen
      saturation, heart rate, intake, and overall status from a parental perspective were used to
      promote communication and attempts of early recognition of deterioration in this high-risk
      population. A strong set of qualitative studies have come from Rempel et al. in Canada on a
      cross-section of mainly white married parents of infants with HLHS and their parenting
      experience. Parenting under Pressure and the Facets of parenting a child with HLHS were
      studies which used the grounded theory approach and provided substantial additions to our
      knowledge of the interstage HLHS parenting experience. The basis of much of the care for all
      types of single ventricle cardiac disease at home is found from the care of HLHS and applied
      to infants with all types of single ventricle anatomy.

      Most hospitals with pediatric cardiac surgery programs have interstage home monitoring
      programs for high risk infants with single ventricle heart disease to provide care and
      support for infants with all types of single ventricle cardiac disease. Education for
      caregivers of infants with single ventricle disease include guidelines to call health care
      providers (HCPs) in cases of hemodynamic interstage concerns, and symptom management
      questions, based on home monitoring of oxygen saturation and weight gain. There are
      variations in the staffing structure between pediatric hospitals but the programs often
      include care coordination and education by a nurse or advanced practice nurse communicating
      with parents in a reactive model waiting for data to be reported.

      mHealth is defined through the National Institutes of Health (NIH) as the use of mobile and
      wireless devices to improve health outcomes, service, and research. The use of applications
      is widespread in adult care with estimated 40,000 health-care applications available. Some
      studies in pediatric medical homes have shown association of mHealth with adherence and
      self-monitoring to improved outcomes. mHealth innovations like the Cardiac High Acuity
      Monitoring Program (CHAMP) and other applications work most effectively when caregivers and
      interstage programs work together to improve care and are a focus of future research from the
      National Institute of Nursing Research. Much of the recent interstage literature focuses on
      mortality and weight measures with little focus on expanding types of outcomes to the
      parental and interstage teams' perspectives and phenomena like infant development.

      Recent developments in technology can provide a proactive means for data transfer for home
      symptom monitoring so the interstage nursing team can review trends and provide proactive
      monitoring for infants in the interstage. Since 2012, two pilot studies have been published
      illustrating varying types of mHealth for the interstage with outcomes of improved somatic
      growth and an improved system of interstage data review but did not show significant
      mortality improvements. An innovative mHealth technology, CHAMP, was begun in 2014 for
      interstage home monitoring symptom management and found improved interstage mortality
      outcomes compared with historical controls. Research gaps remain in the role of adherence in
      this population to the mHealth technology and the parental experience of utilizing these
      innovative methods for communication with the clinical team.

      Rationale The purpose of this study is to provide a rich description of the parental
      perspectives of utilizing a mHealth application for data transfer during the single ventricle
      interstage monitoring period for infants with congenital heart disease. The use of the case
      study design in healthcare has been encouraged by Robert Yin because it adapts to the
      complexity of interactions in a system that may be rapidly changing. Yin's qualitative case
      research "design propositions", presented below for this study, are applied to the literature
      and the PI's professional experience to focus the scope of the study and improve feasibility
      of completion of this qualitative case study approach research study. Propositions in this
      type of qualitative design are similar to hypothesis in quantitative designs to help
      formulate themes emerging from the data. The use of propositions may help with contributions
      for the body of knowledge after generalizing case study analysis, especially in cases of
      critical or extreme cases. Comparative analysis of the theoretical target (non-adherent
      parents) and rival cases (adherent parents) within the case study are improved with study
      propositions to guide the organization of data.

      Study Propositions:

        1. The parental perspectives of the interstage period will influence the use of a home
           monitoring mHealth technology

        2. Parental perception of non-adherence of CHAMP and communication to the clinical team
           will match the actual non-adherence patterns of the mHealth innovation

        3. The use of Cardiac High Acuity Monitoring Program (CHAMP) application from the parental
           perspective will benefit future improvements in this technology

        4. Parents of infants with single ventricle will report the interstage report as a
           stressful time

      Research Design

      Methods. The proposed research study uses a comparative case study methodology, utilizing
      multiple sources of data to deeply examine 8-10 "cases," each of which is defined as
      parent(s) of a child (< 5 years of age) with single ventricle disease who used the mHealth
      application. One group of cases (4-5) will have used the mHealth application less than
      recommended (non-adherent to the home monitoring recommendations) or declined to use the
      application and returned it before the end of the interstage period. The other group of
      comparison cases (4-5 cases) will have used the application as recommended by the clinical
      team (adherent) and continued doing so through the interstage period.

      Yin defines various types of cases, including, explanatory or causal case studies,
      descriptive case studies, and exploratory case studies. The cases in this study are
      exploratory in that they focus on "what" can be learned from these cases of using a novel
      mHealth innovation and the CHAMP care team as a unit. Across the U.S., nearly 2,000 infants
      are born with single ventricle cardiac disease each year but the actual experience at home is
      difficult to comprehend. The research design is a multiple case study design with embedded
      units of non-adherent and adherent cases of parental use of CHAMP within the larger case
      group through the CHAMP Clinic at Children's Mercy Kansas City.

      Data sources will include semi-structured interviews with parents that include observations
      of simulated home monitoring equipment and processes that had been previously used including
      location, time of day, and frequency.
observational model: Family-Based
time perspective: Prospective
measure: Adherence to technology
time frame: 6 months
description: parental perspective on interstage period will influence the number of Data days during the interstage period
measure: Non-adherence to mHealth technology
time frame: 6 months
description: Parental perception of non-adherence of mHealth (CHAMP) and communication to the clinical team will match the actual non-adherence patterns of the mHealth innovation
measure: Parental Stress
time frame: 6 months
description: Parents of infants with single ventricle will report the interstage report as a stressful time
arm group label: Adherent Group
description: Parent(s) that submitted a high rate of data transfer (top 25th percentile) with rate of data days of mHealth technology for data transfer
arm group label: Non-Adherent Group
description: Parent(s) that chose to return mHealth technology before the end of the interstage period and/or low rate of data transfer (bottom 25th percentile) with rate of data days
intervention type: Other
intervention name: Interview
description: The proposed research study uses a comparative case study methodology, utilizing multiple sources of data to deeply examine 8-10 "cases," each of which is defined as parent(s) of a child (< 5 years of age) with single ventricle disease who used the mHealth application. One group of cases (4-5) will have used the mHealth application less than recommended (non-adherent to the home monitoring recommendations) or declined to use the application and returned it before the end of the interstage period. The other group of comparison cases (4-5 cases) will have used the application as recommended by the clinical team (adherent) and continued doing so through the interstage period.
arm group label: Adherent Group
arm group label: Non-Adherent Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Lori Erickson, MSN
role: Principal Investigator
affiliation: Children's Mercy Kansas City
facility: 
country: United States
citation: Shirali G, Erickson L, Apperson J, Goggin K, Williams D, Reid K, Bradley-Ewing A, Tucker D, Bingler M, Spertus J, Rabbitt L, Stroup R. Harnessing Teams and Technology to Improve Outcomes in Infants With Single Ventricle. Circ Cardiovasc Qual Outcomes. 2016 May;9(3):303-11. doi: 10.1161/CIRCOUTCOMES.115.002452. Epub 2016 May 10.
PMID: 27166202
citation: Yin RK. Enhancing the quality of case studies in health services research. Health Serv Res. 1999 Dec;34(5 Pt 2):1209-24.
PMID: 10591280
citation: Black AK, Sadanala UK, Mascio CE, Hornung CA, Keller BB. Challenges in implementing a pediatric cardiovascular home telehealth project. Telemed J E Health. 2014 Sep;20(9):858-67. doi: 10.1089/tmj.2013.0343. Epub 2014 Aug 1.
PMID: 25083905
citation: Rempel GR, Harrison MJ. Safeguarding precarious survival: parenting children who have life-threatening heart disease. Qual Health Res. 2007 Jul;17(6):824-37. doi: 10.1177/1049732307303164.
PMID: 17582024
responsible party type: Principal Investigator
investigator affiliation: Children's Mercy Hospital Kansas City
investigator full name: Lori Erickson
investigator title: CHAMP Clinical Program Manager, MSN, CPNP-PC
mesh term: Univentricular Heart
sharing ipd: No