<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/NCT02233036</url>
  </required_header>
  <id_info>
    <org_study_id>999914088</org_study_id>
    <secondary_id>14-I-N088</secondary_id>
    <nct_id>NCT02233036</nct_id>
  </id_info>
  <brief_title>Evaluating the Transition From Pediatric to Adult Care Among Adolescents With Chronic Granulomatous Disease</brief_title>
  <official_title>Evaluating the Transition From Pediatric to Adult Care Among Adolescents With Chronic Granulomatous Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      People who get chronic illnesses as children are living longer. When they turn 18, they&#xD;
      switch from pediatric care to adult care. This can be a difficult change. Chronic&#xD;
      Granulomatous Disease (CGD) is an inherited disease. It causes long-term, repeated&#xD;
      infections. People with CGD are usually diagnosed when they are very young children.&#xD;
      Researchers want to find out more about how young people with CGD handle the change to adult&#xD;
      care. What they learn may make this easier for people with CGD in the future.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      - To identify what helped or hurt young adults with CGD as they went from pediatric to adult&#xD;
      care.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Adults with CGD who were 18 24 years old between January 2011 and February 2014.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will already be enrolled in NIH studies.&#xD;
&#xD;
        -  Eligible people will get materials in the mail. They will get a letter with study&#xD;
           information, an interview questionnaire, and an information sheet.&#xD;
&#xD;
        -  Researchers will call participants 1 week after the packets are sent. They will talk&#xD;
           about the study and find out if the person wants to join.&#xD;
&#xD;
        -  An interview will be completed immediately or scheduled for the future. The interview&#xD;
           will take about 45 minutes. The researcher will ask the participant about their disease.&#xD;
           They will also ask about travel to NIH, being an outpatient or inpatient there, and&#xD;
           legal documents.&#xD;
&#xD;
        -  Researchers may contact the subjects again by phone if they need more information at any&#xD;
           point during the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children with chronic illnesses are thriving well into adulthood due to ongoing medical&#xD;
      advances. Many healthy and typically developing 18-year-olds should be able to manage a&#xD;
      transition from pediatric to adult care, but this transition can be challenging for&#xD;
      adolescents with chronic illness. A poor transition to adult care can result in medical,&#xD;
      social and educational issues for patients, families and the medical team. At issue are&#xD;
      questions of independence and self-management: are young adult patients prepared to travel to&#xD;
      NIH alone? Are they prepared to speak with physicians about their disease process and&#xD;
      medications? Are they ready to give informed consent for studies in which they have been&#xD;
      participating?&#xD;
&#xD;
      The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes&#xD;
      of Health (NIH) has several hundred adolescents enrolled in clinical trials, many of whom&#xD;
      rely on NIH providers for specialized care. No formal program exists to assist these patients&#xD;
      in the transition from pediatric to adult care. Pediatric inpatients are admitted to the&#xD;
      adult inpatient unit when they turn 18 with little knowledge of the policy differences&#xD;
      between the units.&#xD;
&#xD;
      The investigators propose a retrospective exploratory descriptive study to (a) identify and&#xD;
      describe experiences that young adults found to enable or hinder their transition and (b)&#xD;
      explore these patients ideas for enhancing the transition process. A semi-structured&#xD;
      questionnaire administered by phone or face to face to approximately 40 young adults with&#xD;
      chronic granulomatous disease (CGD) will gather qualitative and quantitative information&#xD;
      about the use of inpatient and outpatient services at the NIH Clinical Center prior to and&#xD;
      since the subjects 18th birthdays. Data will be used to develop a program to help NIAID&#xD;
      pediatric patients with CGD transition successfully to adult care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 26, 2014</start_date>
  <completion_date type="Actual">January 10, 2017</completion_date>
  <primary_completion_date type="Actual">January 11, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Successful transition to adult care</measure>
    <time_frame>After completion of interview</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To explore strategies that young adult patients believe mayenhance the process of transition from pediatric to adult care</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">33</enrollment>
  <condition>CGD</condition>
  <eligibility>
    <criteria>
      <textblock>
        -INCLUSION CRITERIA:&#xD;
&#xD;
          1. 18 to 24 years of age during January 1, 2011 to December 31, 2012&#xD;
&#xD;
          2. Documented diagnosis of CGD&#xD;
&#xD;
          3. Enrolled in one of the following three NIAID protocols that investigate CGD (and other&#xD;
             immunodeficiencies):&#xD;
&#xD;
               -  Detection and Characterization of Host Defense Defects (93-I-0119), PI: Dr.&#xD;
                  Steven Holland&#xD;
&#xD;
               -  Screening and Baseline Assessment of Patients with Abnormalities of Immune&#xD;
                  Function (05-I-0213), PI: Dr. Harry Malech&#xD;
&#xD;
               -  Screening Protocol for Detection and Characterization of Infections and Infection&#xD;
                  (07-I-0033), PI: Dr. Steven Holland&#xD;
&#xD;
          4. Record of a visit to NIH prior to 18th birthday and at least one visit during January&#xD;
             1, 2011 to December 31, 2012&#xD;
&#xD;
          5. Health status sufficient to participate in an interview, as determined by patient&#xD;
             self-report at the start of the interview.&#xD;
&#xD;
          6. Fluency in English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia R Driscoll, R.N.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Allergy and Infectious Diseases (NIAID)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Fernandes SM, Landzberg MJ. Transitioning the young adult with congenital heart disease for life-long medical care. Pediatr Clin North Am. 2004 Dec;51(6):1739-48, xi. doi: 10.1016/j.pcl.2004.07.006.</citation>
    <PMID>15561183</PMID>
  </reference>
  <reference>
    <citation>Kennedy A, Sloman F, Douglass JA, Sawyer SM. Young people with chronic illness: the approach to transition. Intern Med J. 2007 Aug;37(8):555-60. doi: 10.1111/j.1445-5994.2007.01440.x.</citation>
    <PMID>17640188</PMID>
  </reference>
  <reference>
    <citation>Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.</citation>
    <PMID>20040605</PMID>
  </reference>
  <verification_date>January 10, 2017</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>April 4, 2018</last_update_submitted>
  <last_update_submitted_qc>April 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Young Adults</keyword>
  <keyword>Transfer</keyword>
  <keyword>Chronic Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Granulomatous Disease, Chronic</mesh_term>
  </condition_browse>
  <!-- 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/NCT02233036
org study id: 999914088
secondary id: 14-I-N088
nct id: NCT02233036
lead sponsor: 
Background:

      People who get chronic illnesses as children are living longer. When they turn 18, they
      switch from pediatric care to adult care. This can be a difficult change. Chronic
      Granulomatous Disease (CGD) is an inherited disease. It causes long-term, repeated
      infections. People with CGD are usually diagnosed when they are very young children.
      Researchers want to find out more about how young people with CGD handle the change to adult
      care. What they learn may make this easier for people with CGD in the future.

      Objective:

      - To identify what helped or hurt young adults with CGD as they went from pediatric to adult
      care.

      Eligibility:

      - Adults with CGD who were 18 24 years old between January 2011 and February 2014.

      Design:

        -  Participants will already be enrolled in NIH studies.

        -  Eligible people will get materials in the mail. They will get a letter with study
           information, an interview questionnaire, and an information sheet.

        -  Researchers will call participants 1 week after the packets are sent. They will talk
           about the study and find out if the person wants to join.

        -  An interview will be completed immediately or scheduled for the future. The interview
           will take about 45 minutes. The researcher will ask the participant about their disease.
           They will also ask about travel to NIH, being an outpatient or inpatient there, and
           legal documents.

        -  Researchers may contact the subjects again by phone if they need more information at any
           point during the study.
Children with chronic illnesses are thriving well into adulthood due to ongoing medical
      advances. Many healthy and typically developing 18-year-olds should be able to manage a
      transition from pediatric to adult care, but this transition can be challenging for
      adolescents with chronic illness. A poor transition to adult care can result in medical,
      social and educational issues for patients, families and the medical team. At issue are
      questions of independence and self-management: are young adult patients prepared to travel to
      NIH alone? Are they prepared to speak with physicians about their disease process and
      medications? Are they ready to give informed consent for studies in which they have been
      participating?

      The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes
      of Health (NIH) has several hundred adolescents enrolled in clinical trials, many of whom
      rely on NIH providers for specialized care. No formal program exists to assist these patients
      in the transition from pediatric to adult care. Pediatric inpatients are admitted to the
      adult inpatient unit when they turn 18 with little knowledge of the policy differences
      between the units.

      The investigators propose a retrospective exploratory descriptive study to (a) identify and
      describe experiences that young adults found to enable or hinder their transition and (b)
      explore these patients ideas for enhancing the transition process. A semi-structured
      questionnaire administered by phone or face to face to approximately 40 young adults with
      chronic granulomatous disease (CGD) will gather qualitative and quantitative information
      about the use of inpatient and outpatient services at the NIH Clinical Center prior to and
      since the subjects 18th birthdays. Data will be used to develop a program to help NIAID
      pediatric patients with CGD transition successfully to adult care.
observational model: Cohort
time perspective: Retrospective
measure: Successful transition to adult care
time frame: After completion of interview
measure: To explore strategies that young adult patients believe mayenhance the process of transition from pediatric to adult care
time frame: 1 year
criteria: 
gender: All
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: No
last name: Patricia R Driscoll, R.N.
role: Principal Investigator
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
facility: 
country: United States
citation: Fernandes SM, Landzberg MJ. Transitioning the young adult with congenital heart disease for life-long medical care. Pediatr Clin North Am. 2004 Dec;51(6):1739-48, xi. doi: 10.1016/j.pcl.2004.07.006.
PMID: 15561183
citation: Kennedy A, Sloman F, Douglass JA, Sawyer SM. Young people with chronic illness: the approach to transition. Intern Med J. 2007 Aug;37(8):555-60. doi: 10.1111/j.1445-5994.2007.01440.x.
PMID: 17640188
citation: Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.
PMID: 20040605
responsible party type: Sponsor
mesh term: Granulomatous Disease, Chronic