<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/NCT03253601</url>
  </required_header>
  <id_info>
    <org_study_id>PRO17030372</org_study_id>
    <nct_id>NCT03253601</nct_id>
  </id_info>
  <brief_title>iADAPT to Support Strategy Training After Stroke</brief_title>
  <official_title>iADAPT to Support Strategy Training After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</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>
      Adherence to rehabilitation interventions is associated with functional outcomes (e.g.&#xD;
      independence in daily activities, return of motor function) after stroke. Low adherence to&#xD;
      rehabilitation home programs is common after stroke. Interventions delivered via mobile&#xD;
      health applications demonstrated positive effects on adherence to health behaviors (e.g.&#xD;
      medication routines, smoking cessation). The investigators developed the iADAPT mobile&#xD;
      application to support adherence to Strategy Training. Strategy Training is an iterative&#xD;
      rehabilitation intervention the promotes goal setting, planning, and self-monitoring after&#xD;
      stroke. This study examines the effects of the iADAPT mobile health application relative to a&#xD;
      workbook on adherence to Strategy Training after stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 8, 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence: Observed client behavior</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>Number of completed activity trials in the iADAPT application or Workbook</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence: Client-reported progress on goals.</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Client rating of independence with self-selected goals (measured using Canadian Occupational Performance Measure)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence: Client perspectives on treatment environment</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Client rating on patient-provider connection and treatment expectancy measured by Healing Encounters and Attitudes Lists</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Stroke</condition>
  <condition>Adherence, Patient</condition>
  <condition>Strategy Training</condition>
  <arm_group>
    <arm_group_label>Strategy Training: iADAPT Application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will use the iADAPT mobile health application to supplement to in-person and remote intervention sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Strategy Training: Workbook</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will use a printed workbook to supplement to in-person and remote (by telephone) intervention sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Strategy Training</intervention_name>
    <description>Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice.</description>
    <arm_group_label>Strategy Training: Workbook</arm_group_label>
    <arm_group_label>Strategy Training: iADAPT Application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Diagnosis of Stroke&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior exposure to Strategy Training&#xD;
&#xD;
          -  vision impairment that impairs ability to read device screen or worksheet&#xD;
&#xD;
          -  poor self-awareness (score of ≥2 on Self Awareness of Deficits Inventory item #1 or #2&#xD;
&#xD;
          -  current major depressive, bipolar, or psychotic disorder (Patient Health&#xD;
             Questionnaire-9, PRIME-MD)&#xD;
&#xD;
          -  current alcohol or drug abuse (Mini International Neuropsychiatric Interview)&#xD;
&#xD;
          -  severe aphasia (score ≤1 on Boston Diagnostic Aphasia Examination)&#xD;
&#xD;
          -  current diagnosis of dementia, neurodegenerative disease, or cancer&#xD;
&#xD;
          -  anticipated discharge to a skilled nursing facility&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth R. Skidmore, PhD, OTR/L</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Elizabeth R. Skidmore, PhD, OTR/L</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <keyword>Disability</keyword>
  <keyword>Mobile Health Technology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT03253601
org study id: PRO17030372
nct id: NCT03253601
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Adherence to rehabilitation interventions is associated with functional outcomes (e.g.
      independence in daily activities, return of motor function) after stroke. Low adherence to
      rehabilitation home programs is common after stroke. Interventions delivered via mobile
      health applications demonstrated positive effects on adherence to health behaviors (e.g.
      medication routines, smoking cessation). The investigators developed the iADAPT mobile
      application to support adherence to Strategy Training. Strategy Training is an iterative
      rehabilitation intervention the promotes goal setting, planning, and self-monitoring after
      stroke. This study examines the effects of the iADAPT mobile health application relative to a
      workbook on adherence to Strategy Training after stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Adherence: Observed client behavior
time frame: Baseline to 3 months
description: Number of completed activity trials in the iADAPT application or Workbook
measure: Adherence: Client-reported progress on goals.
time frame: Baseline and 3 months
description: Client rating of independence with self-selected goals (measured using Canadian Occupational Performance Measure)
measure: Adherence: Client perspectives on treatment environment
time frame: Baseline and 3 months
description: Client rating on patient-provider connection and treatment expectancy measured by Healing Encounters and Attitudes Lists
arm group label: Strategy Training: iADAPT Application
arm group type: Experimental
description: Participants will use the iADAPT mobile health application to supplement to in-person and remote intervention sessions.
arm group label: Strategy Training: Workbook
arm group type: Active Comparator
description: Participants will use a printed workbook to supplement to in-person and remote (by telephone) intervention sessions.
intervention type: Behavioral
intervention name: Strategy Training
description: Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice.
arm group label: Strategy Training: Workbook
arm group label: Strategy Training: iADAPT Application
criteria: 
gender: All
minimum age: 18 Years
maximum age: 105 Years
healthy volunteers: No
last name: Elizabeth R. Skidmore, PhD, OTR/L
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Elizabeth R. Skidmore, PhD, OTR/L
investigator title: Professor
mesh term: Stroke
sharing ipd: No