<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/NCT02987569</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00004067</org_study_id>
    <secondary_id>R01NR015743-01A1</secondary_id>
    <nct_id>NCT02987569</nct_id>
  </id_info>
  <brief_title>Teen and Young Adult Connections for Support From Multidisciplinary Professionals &amp; Peers</brief_title>
  <official_title>Teen Connections for Support From Multidisciplinary Professionals &amp; Peers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      12 month study testing mobile delivery of health information and connections to professionals&#xD;
      and peers to improve health of teen/young adult HPN users.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study will test the effect of in-home/mobile HPN support delivered to teen and&#xD;
      young adult home parenteral nutrition (HPN) patients and family members over handheld&#xD;
      personal computers. Effects on health status, QoL, and fatigue will be assessed over time&#xD;
      between groups of study subjects from the ages of 13 through 30 randomized to one of two&#xD;
      groups. Group One (intervention group) will receive mConnect, integrated evidence-based&#xD;
      interventions (skill-building games, restorative naps &amp; peer support) via mobile iPad and&#xD;
      Internet delivery plus two real-time audiovisual encrypted connections with multidisciplinary&#xD;
      professionals and peers. Group Two (control group) will receive healthy activity information&#xD;
      via mobile iPad and Internet delivery plus one real-time audiovisual encrypted connection&#xD;
      with professionals and peers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">June 2020</completion_date>
  <primary_completion_date type="Actual">December 2019</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health Survey SF-12v2 (predicts future health services use).</measure>
    <time_frame>T0 (baseline data collection)</time_frame>
    <description>Physical and mental health status from each person's perspective. 7-Item Likert</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life (Cantril Ladder)</measure>
    <time_frame>T0 (baseline data collection)</time_frame>
    <description>Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory-II (BDI-II)</measure>
    <time_frame>T0 (baseline data collection)</time_frame>
    <description>Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.</measure>
    <time_frame>T2 (month 1-2/mConnect intervention period)</time_frame>
    <description>Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.</measure>
    <time_frame>T3 (month 3-4/mConnect intervention period)</time_frame>
    <description>Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory-II (BDI-II)</measure>
    <time_frame>T3 (4 months: change from T0/baseline)</time_frame>
    <description>Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Survey SF-12v2 (predicts future health services use).</measure>
    <time_frame>T3 (4 months: change from T0/baseline)</time_frame>
    <description>Physical and mental health status from each person's perspective. 7-Item Likert</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life (Cantril Ladder)</measure>
    <time_frame>T3 (4 months: change from T0/baseline)</time_frame>
    <description>Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Survey SF-12v2 (predicts future health services use).</measure>
    <time_frame>T4 (8 months: change from T3/4 months)</time_frame>
    <description>Physical and mental health status from each person's perspective. 7-Item Likert</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life (Cantril Ladder)</measure>
    <time_frame>T4 (8 months: change from T3/4 months)</time_frame>
    <description>Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory-II (BDI-II)</measure>
    <time_frame>T4 (8 months: change from T3/4 months)</time_frame>
    <description>Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Survey SF-12v2 (predicts future health services use).</measure>
    <time_frame>T5 (12 months: change from T4/8 months)</time_frame>
    <description>Physical and mental health status from each person's perspective. 7-Item Likert</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life (Cantril Ladder)</measure>
    <time_frame>T5 (12 months: change from T4/8 months)</time_frame>
    <description>Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory-II (BDI-II)</measure>
    <time_frame>T5 (12 months: change from T4/8 months)</time_frame>
    <description>Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preparedness (measures skills needed for independent HPN home care).</measure>
    <time_frame>T0 (baseline data collection)</time_frame>
    <description>Ability to manage home-care; low score = needs home care assistance. 8-Item Likert</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COOPS Social Support Scale</measure>
    <time_frame>T0 (baseline data collection)</time_frame>
    <description>Ratings on having others who help, listen &amp; provide tangible assistance support. 13-Item Likert</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preparedness (measures skills needed for independent HPN home care).</measure>
    <time_frame>T3 (4 months: change from T0/baseline)</time_frame>
    <description>Ability to manage home-care; low score = needs home care assistance. 8-Item Likert</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COOPS Social Support Scale</measure>
    <time_frame>T3 (4 months: change from T0/baseline)</time_frame>
    <description>Ratings on having others who help, listen &amp; provide tangible assistance support. 13-Item Likert</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobile Care Helpfulness &amp; Willingness-to-Pay Fees for Distance Health.</measure>
    <time_frame>T4 (8 months)</time_frame>
    <description>Rating of Helpfulness and willingness to pay for mobile care delivery. 10-Item Likert</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preparedness (measures skills needed for independent HPN home care).</measure>
    <time_frame>T4 (8 months: change from T3/4 months)</time_frame>
    <description>Ability to manage home-care; low score = needs home care assistance. 8-Item Likert</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COOPS Social Support Scale</measure>
    <time_frame>T4 (8 months: change from T3/4 months)</time_frame>
    <description>Ratings on having others who help, listen &amp; provide tangible assistance support. 13-Item Likert</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preparedness (measures skills needed for independent HPN home care).</measure>
    <time_frame>T5 (12 months: change from T4/8 months)</time_frame>
    <description>Ability to manage home-care; low score = needs home care assistance. 8-Item Likert</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COOPS Social Support Scale</measure>
    <time_frame>T5 (12 months: change from T4/8 months)</time_frame>
    <description>Ratings on having others who help, listen &amp; provide tangible assistance support. 13-Item Likert</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Short Bowel Syndrome</condition>
  <condition>Malabsorption</condition>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>Group One</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Two</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mConnect plus mobile connections to multidisciplinary professionals &amp; peers</intervention_name>
    <description>mConnect is the integration of evidence-based HPN interventions delivered via professionally moderated iPad visual meetings with peers, and reinforced by HPN related skill-building games (apps) and iPad music guided short naps.</description>
    <arm_group_label>Group One</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>iPad use plus one mobile connections to multidisciplinary professionals &amp; peers</intervention_name>
    <description>iPad with a data plan and one professionally moderated iPad visual meeting with peers.</description>
    <arm_group_label>Group Two</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Total parenteral nutrition (TPN) patients/users and family members/caregivers (defined&#xD;
             as those individuals involved in daily home HPN care) age 13 and older&#xD;
&#xD;
          -  TPN users (also called HPN users) ages 13 through 30 must be receiving intravenous&#xD;
             nutrition for a non-malignant short bowel disorder&#xD;
&#xD;
          -  Read, write, speak English and provide informed consent&#xD;
&#xD;
          -  Be able to participate in group clinic visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Enteral nutrition dependency only&#xD;
&#xD;
          -  Less than 13 years of age&#xD;
&#xD;
          -  13 through 17 years of age without parental consent&#xD;
&#xD;
          -  Currently enrolled in an intervention study or HPN management program&#xD;
&#xD;
          -  Severe cognitive impairment&#xD;
&#xD;
          -  Disability disorders (e.g. blindness which cannot be accommodated for active&#xD;
             participation in the group clinics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carol E Smith, RN, PhD, FAAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Nelson EL, Yadrich DM, Thompson N, Wright S, Stone K, Adams N, Werkowitch M, Smith CE. Telemedicine Support Groups for Home Parenteral Nutrition Users. Nutr Clin Pract. 2017 Dec;32(6):789-798. doi: 10.1177/0884533617735527. Epub 2017 Oct 10.</citation>
    <PMID>29016235</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>November 30, 2020</last_update_submitted>
  <last_update_submitted_qc>November 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Home Parenteral Nutrition</keyword>
  <keyword>HPN</keyword>
  <keyword>Total Parenteral Nutrition</keyword>
  <keyword>TPN</keyword>
  <keyword>mConnect</keyword>
  <keyword>SBS</keyword>
  <keyword>short bowel disorder</keyword>
  <keyword>telehealth</keyword>
  <keyword>telemedicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Short Bowel Syndrome</mesh_term>
    <mesh_term>Malabsorption Syndromes</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All data is de-identified and will be reported only in aggregate.</ipd_description>
  </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/NCT02987569
org study id: STUDY00004067
secondary id: R01NR015743-01A1
nct id: NCT02987569
lead sponsor: 
collaborator: 
has dmc: Yes
12 month study testing mobile delivery of health information and connections to professionals
      and peers to improve health of teen/young adult HPN users.
This research study will test the effect of in-home/mobile HPN support delivered to teen and
      young adult home parenteral nutrition (HPN) patients and family members over handheld
      personal computers. Effects on health status, QoL, and fatigue will be assessed over time
      between groups of study subjects from the ages of 13 through 30 randomized to one of two
      groups. Group One (intervention group) will receive mConnect, integrated evidence-based
      interventions (skill-building games, restorative naps & peer support) via mobile iPad and
      Internet delivery plus two real-time audiovisual encrypted connections with multidisciplinary
      professionals and peers. Group Two (control group) will receive healthy activity information
      via mobile iPad and Internet delivery plus one real-time audiovisual encrypted connection
      with professionals and peers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Health Survey SF-12v2 (predicts future health services use).
time frame: T0 (baseline data collection)
description: Physical and mental health status from each person's perspective. 7-Item Likert
measure: Quality of Life (Cantril Ladder)
time frame: T0 (baseline data collection)
description: Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
measure: Beck Depression Inventory-II (BDI-II)
time frame: T0 (baseline data collection)
description: Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item
measure: Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.
time frame: T2 (month 1-2/mConnect intervention period)
description: Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert
measure: Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.
time frame: T3 (month 3-4/mConnect intervention period)
description: Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert
measure: Beck Depression Inventory-II (BDI-II)
time frame: T3 (4 months: change from T0/baseline)
description: Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item
measure: Health Survey SF-12v2 (predicts future health services use).
time frame: T3 (4 months: change from T0/baseline)
description: Physical and mental health status from each person's perspective. 7-Item Likert
measure: Quality of Life (Cantril Ladder)
time frame: T3 (4 months: change from T0/baseline)
description: Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
measure: Health Survey SF-12v2 (predicts future health services use).
time frame: T4 (8 months: change from T3/4 months)
description: Physical and mental health status from each person's perspective. 7-Item Likert
measure: Quality of Life (Cantril Ladder)
time frame: T4 (8 months: change from T3/4 months)
description: Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
measure: Beck Depression Inventory-II (BDI-II)
time frame: T4 (8 months: change from T3/4 months)
description: Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item
measure: Health Survey SF-12v2 (predicts future health services use).
time frame: T5 (12 months: change from T4/8 months)
description: Physical and mental health status from each person's perspective. 7-Item Likert
measure: Quality of Life (Cantril Ladder)
time frame: T5 (12 months: change from T4/8 months)
description: Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
measure: Beck Depression Inventory-II (BDI-II)
time frame: T5 (12 months: change from T4/8 months)
description: Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item
measure: Preparedness (measures skills needed for independent HPN home care).
time frame: T0 (baseline data collection)
description: Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
measure: COOPS Social Support Scale
time frame: T0 (baseline data collection)
description: Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
measure: Preparedness (measures skills needed for independent HPN home care).
time frame: T3 (4 months: change from T0/baseline)
description: Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
measure: COOPS Social Support Scale
time frame: T3 (4 months: change from T0/baseline)
description: Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
measure: Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health.
time frame: T4 (8 months)
description: Rating of Helpfulness and willingness to pay for mobile care delivery. 10-Item Likert
measure: Preparedness (measures skills needed for independent HPN home care).
time frame: T4 (8 months: change from T3/4 months)
description: Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
measure: COOPS Social Support Scale
time frame: T4 (8 months: change from T3/4 months)
description: Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
measure: Preparedness (measures skills needed for independent HPN home care).
time frame: T5 (12 months: change from T4/8 months)
description: Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
measure: COOPS Social Support Scale
time frame: T5 (12 months: change from T4/8 months)
description: Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
arm group label: Group One
arm group type: Experimental
description: Intervention
arm group label: Group Two
arm group type: Active Comparator
description: Control
intervention type: Behavioral
intervention name: mConnect plus mobile connections to multidisciplinary professionals & peers
description: mConnect is the integration of evidence-based HPN interventions delivered via professionally moderated iPad visual meetings with peers, and reinforced by HPN related skill-building games (apps) and iPad music guided short naps.
arm group label: Group One
intervention type: Behavioral
intervention name: iPad use plus one mobile connections to multidisciplinary professionals & peers
description: iPad with a data plan and one professionally moderated iPad visual meeting with peers.
arm group label: Group Two
criteria: 
gender: All
minimum age: 13 Years
maximum age: 30 Years
healthy volunteers: No
last name: Carol E Smith, RN, PhD, FAAN
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
citation: Nelson EL, Yadrich DM, Thompson N, Wright S, Stone K, Adams N, Werkowitch M, Smith CE. Telemedicine Support Groups for Home Parenteral Nutrition Users. Nutr Clin Pract. 2017 Dec;32(6):789-798. doi: 10.1177/0884533617735527. Epub 2017 Oct 10.
PMID: 29016235
responsible party type: Sponsor
mesh term: Short Bowel Syndrome
mesh term: Malabsorption Syndromes
mesh term: Malnutrition
sharing ipd: No
ipd description: All data is de-identified and will be reported only in aggregate.