<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/NCT03820011</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0600</org_study_id>
    <nct_id>NCT03820011</nct_id>
  </id_info>
  <brief_title>Participation and Environment Measure-Plus (PEM-Plus) Care Planning Intervention</brief_title>
  <acronym>PEM-Plus</acronym>
  <official_title>Feasibility Test of a Pediatric Web-Based Care Planning Guide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mary A Khetani</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Chicago</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 goal of the proposed research is to achieve a major advance in promoting effective and&#xD;
      efficient delivery of pediatric rehabilitation services for young children with developmental&#xD;
      disabilities and delays. The investigative team will examine the usability, feasibility,&#xD;
      acceptability, and preliminary effects of PEM+, an innovative web-based (mobile friendly)&#xD;
      guide for care planning by parents of young children with developmental disabilities and&#xD;
      delays. PEM+ is designed in partnership with parents and providers to support more&#xD;
      collaborative and efficient clinical care planning with individual families who typically&#xD;
      access pediatric occupational therapy services. Specifically, PEM+ enables parents to build&#xD;
      on their baseline assessment of their child using the Young Children's Participation and&#xD;
      Environment Measure (YC-PEM) to design specific solutions to their young child's&#xD;
      participation-related problems. PEM+ affords parents the opportunity to do this in their own&#xD;
      space and on their own schedule, as well as electronically share their proposed written&#xD;
      solutions with their child's provider(s) and/or other important individuals in their young&#xD;
      child's life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participation and Environment Measure Plus (PEM+) is a new electronic health application that&#xD;
      facilitates family-centered and participation-focused intervention planning for young&#xD;
      children receiving rehabilitation therapies. PEM+ design was informed by caregiver and&#xD;
      provider input. It is a web-based intervention planning application that is designed for use&#xD;
      by caregivers of young children receiving rehabilitation therapies. Caregivers who complete&#xD;
      the Young Children's Participation and Environment Measure (YC-PEM), an electronic&#xD;
      patient-reported outcome measure, evaluate their child's participation and then can click on&#xD;
      a weblink to begin the PEM+ application, whereby they build on their YC-PEM responses for the&#xD;
      purpose of creating a participation-focused care plan to share with their child's&#xD;
      rehabilitation team. PEM+ is a five-step recursive process (i.e., the caregiver can repeat&#xD;
      the five-step process to create as many care plans for their child as needed), and it offers&#xD;
      tiered support to the user during completion (tier 1: frequently asked questions available in&#xD;
      the application, tier 2: support provided by email, tier 3: support provided by phone). For&#xD;
      the first aim of this study, caregivers completed one iteration of PEM+ to complete user&#xD;
      tasks for the purpose of evaluating PEM+ usability. For the second aim of this study,&#xD;
      caregivers were instructed to complete the PEM+ over a two-week (14 day) period. This time&#xD;
      frame was selected by the research team as it mimics what would be provided in the routine&#xD;
      care planning processes of early intervention and early childhood education.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Anticipated">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean retention rates</measure>
    <time_frame>Following completion of two-week trial</time_frame>
    <description>As an indicator of PEM+ feasibility, we used web analytics to obtain estimates of the percentage of caregivers who enrolled completed the trial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Median PEM+ completion time</measure>
    <time_frame>Following completion of two-week trial</time_frame>
    <description>As an indicator of PEM+ feasibility, we used web analytics to estimate the median time for completing the first and subsequent iterations within a two-week trial period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of caregivers completing PEM+ independently</measure>
    <time_frame>Following completion of two-week trial</time_frame>
    <description>As an indicator of PEM+ feasibility, we used web analytics to estimate proportion of care plans created</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Median number of PEM+ care plans created</measure>
    <time_frame>Following completion of two-week trial</time_frame>
    <description>As an indicator of PEM+ feasibility, we used web analytics estimate the number of care plans created over a two-week trial period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Usefulness, Satisfaction, and Ease of Use Questionnaire (USE)</measure>
    <time_frame>Following completion of two-week trial</time_frame>
    <description>As an indicator of PEM+ acceptability, the USE is a questionnaire that evaluates usefulness, ease of use, ease of learning, and satisfaction. Items are on a 7-point scale, from from [1] strongly disagree, to [7] strongly agree.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Caregiver Self-Efficacy to Promote Child's Participation in Activities</measure>
    <time_frame>Following completion of two-week trial</time_frame>
    <description>As an indicator of preliminary effects, we developed two items for this project to estimate caregiver self-efficacy in caring for their child, according to &quot;what I will do next [to support child's participation]&quot; and &quot;how I think [about my child's participation]&quot;. Each item was rated on a 7-point scale, from [1] strongly disagree, to [7] strongly agree.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Developmental Disability</condition>
  <condition>Early Intervention (Education)</condition>
  <arm_group>
    <arm_group_label>PEM-Plus Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For Aim 1, 6 parents of young children were recruited to perform tasks related to navigating the PEM+ interface. Data on completion rate and time, as well as user satisfaction, were analyzed to guide PEM+ improvements. For Aim 2, we recruited 26 participants to enroll in a feasibility trial of PEM+. Caregivers who completed the YC-PEM e-PRO to evaluate their child's participation clicked on a weblink to begin PEM+, whereby they built on their YC-PEM responses for the purpose of creating a participation-focused care plan to share with their child's rehabilitation team. Caregivers were instructed to complete the PEM+ over a two-week (14 day) period because it mimics what would be provided in routine care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PEM+</intervention_name>
    <description>PEM+ is a five-step recursive process (i.e., the caregiver can repeat the five-step process to create as many intervention plans for their child as needed, relative to the number of activities in which change is desired based on the YC-PEM e-PRO, and it offers tiered support to the user during completion (tier 1: frequently asked questions available in the application, tier 2: support provided by email, tier 3: support provided by phone).</description>
    <arm_group_label>PEM-Plus Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For Aim 1, participants met the following inclusion criteria: the caregiver is at&#xD;
             least 18 years old; reads, writes, and speaks English; has access to broadband&#xD;
             internet; resides in the U.S; and has a child between 0 and 3 years old who is&#xD;
             receiving services for developmental delay.&#xD;
&#xD;
          -  For Aim 2, caregivers were eligible for inclusion if they: 1) were 18 years or older;&#xD;
             2) spoke and write English; 3) had a child aged 0-5 years old who was receiving&#xD;
             rehabilitation services; 4) had broadband internet access; and 5) denoted at least one&#xD;
             area of desired change during participation assessment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Mary A Khetani</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>participation</keyword>
  <keyword>environment</keyword>
  <keyword>goal setting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Developmental Disabilities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 28, 2019</submitted>
    <returned>April 26, 2019</returned>
    <submitted>May 26, 2020</submitted>
    <returned>June 18, 2020</returned>
    <submitted>September 22, 2020</submitted>
    <returned>October 16, 2020</returned>
    <submitted>March 10, 2022</submitted>
    <returned>March 11, 2022</returned>
  </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/NCT03820011
org study id: 2016-0600
nct id: NCT03820011
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of the proposed research is to achieve a major advance in promoting effective and
      efficient delivery of pediatric rehabilitation services for young children with developmental
      disabilities and delays. The investigative team will examine the usability, feasibility,
      acceptability, and preliminary effects of PEM+, an innovative web-based (mobile friendly)
      guide for care planning by parents of young children with developmental disabilities and
      delays. PEM+ is designed in partnership with parents and providers to support more
      collaborative and efficient clinical care planning with individual families who typically
      access pediatric occupational therapy services. Specifically, PEM+ enables parents to build
      on their baseline assessment of their child using the Young Children's Participation and
      Environment Measure (YC-PEM) to design specific solutions to their young child's
      participation-related problems. PEM+ affords parents the opportunity to do this in their own
      space and on their own schedule, as well as electronically share their proposed written
      solutions with their child's provider(s) and/or other important individuals in their young
      child's life.
Participation and Environment Measure Plus (PEM+) is a new electronic health application that
      facilitates family-centered and participation-focused intervention planning for young
      children receiving rehabilitation therapies. PEM+ design was informed by caregiver and
      provider input. It is a web-based intervention planning application that is designed for use
      by caregivers of young children receiving rehabilitation therapies. Caregivers who complete
      the Young Children's Participation and Environment Measure (YC-PEM), an electronic
      patient-reported outcome measure, evaluate their child's participation and then can click on
      a weblink to begin the PEM+ application, whereby they build on their YC-PEM responses for the
      purpose of creating a participation-focused care plan to share with their child's
      rehabilitation team. PEM+ is a five-step recursive process (i.e., the caregiver can repeat
      the five-step process to create as many care plans for their child as needed), and it offers
      tiered support to the user during completion (tier 1: frequently asked questions available in
      the application, tier 2: support provided by email, tier 3: support provided by phone). For
      the first aim of this study, caregivers completed one iteration of PEM+ to complete user
      tasks for the purpose of evaluating PEM+ usability. For the second aim of this study,
      caregivers were instructed to complete the PEM+ over a two-week (14 day) period. This time
      frame was selected by the research team as it mimics what would be provided in the routine
      care planning processes of early intervention and early childhood education.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean retention rates
time frame: Following completion of two-week trial
description: As an indicator of PEM+ feasibility, we used web analytics to obtain estimates of the percentage of caregivers who enrolled completed the trial.
measure: Median PEM+ completion time
time frame: Following completion of two-week trial
description: As an indicator of PEM+ feasibility, we used web analytics to estimate the median time for completing the first and subsequent iterations within a two-week trial period
measure: Percentage of caregivers completing PEM+ independently
time frame: Following completion of two-week trial
description: As an indicator of PEM+ feasibility, we used web analytics to estimate proportion of care plans created
measure: Median number of PEM+ care plans created
time frame: Following completion of two-week trial
description: As an indicator of PEM+ feasibility, we used web analytics estimate the number of care plans created over a two-week trial period.
measure: Usefulness, Satisfaction, and Ease of Use Questionnaire (USE)
time frame: Following completion of two-week trial
description: As an indicator of PEM+ acceptability, the USE is a questionnaire that evaluates usefulness, ease of use, ease of learning, and satisfaction. Items are on a 7-point scale, from from [1] strongly disagree, to [7] strongly agree.
measure: Caregiver Self-Efficacy to Promote Child's Participation in Activities
time frame: Following completion of two-week trial
description: As an indicator of preliminary effects, we developed two items for this project to estimate caregiver self-efficacy in caring for their child, according to "what I will do next [to support child's participation]" and "how I think [about my child's participation]". Each item was rated on a 7-point scale, from [1] strongly disagree, to [7] strongly agree.
arm group label: PEM-Plus Group
arm group type: Experimental
description: For Aim 1, 6 parents of young children were recruited to perform tasks related to navigating the PEM+ interface. Data on completion rate and time, as well as user satisfaction, were analyzed to guide PEM+ improvements. For Aim 2, we recruited 26 participants to enroll in a feasibility trial of PEM+. Caregivers who completed the YC-PEM e-PRO to evaluate their child's participation clicked on a weblink to begin PEM+, whereby they built on their YC-PEM responses for the purpose of creating a participation-focused care plan to share with their child's rehabilitation team. Caregivers were instructed to complete the PEM+ over a two-week (14 day) period because it mimics what would be provided in routine care.
intervention type: Other
intervention name: PEM+
description: PEM+ is a five-step recursive process (i.e., the caregiver can repeat the five-step process to create as many intervention plans for their child as needed, relative to the number of activities in which change is desired based on the YC-PEM e-PRO, and it offers tiered support to the user during completion (tier 1: frequently asked questions available in the application, tier 2: support provided by email, tier 3: support provided by phone).
arm group label: PEM-Plus Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Mary A Khetani
investigator title: Associate Professor
mesh term: Developmental Disabilities
sharing ipd: No
submitted: January 28, 2019
returned: April 26, 2019
submitted: May 26, 2020
returned: June 18, 2020
submitted: September 22, 2020
returned: October 16, 2020
submitted: March 10, 2022
returned: March 11, 2022