xml: <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/NCT05964400</url>
    </required_header>
    <id_info>
      <org_study_id>duoABLE</org_study_id>
      <secondary_id>AOTFIRG23KRINGLE</secondary_id>
      <nct_id>NCT05964400</nct_id>
    </id_info>
    <brief_title>duoABLE for People With Stroke and Their Caregivers</brief_title>
    <official_title>duoABLE for People With Stroke and Their Caregivers (Feasibility)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Minnesota</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Occupational Therapy Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Minnesota</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 this intervention study is to test whether a behavioral program that involves&#xD;
        people with stroke and their caregivers is acceptable, safe, and can promote physically&#xD;
        active lifestyles using enjoyable activities. Participant duos (person with stroke and their&#xD;
        caregiver) will be asked to complete assessments at 2 timepoints, wear an activity tracker,&#xD;
        participate in 12 sessions with an occupational therapist, and complete an interview.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</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>Participant satisfaction</measure>
      <time_frame>Score at week 8</time_frame>
      <description>Measured using the Client Satisfaction Questionnaire-8 (CSQ-8)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in activity restrictions</measure>
      <time_frame>Baseline to 8 weeks</time_frame>
      <description>Proportion of activities retained assessed at baseline and 8-weeks by the Activity Card Sort 3</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in sedentary minutes per day</measure>
      <time_frame>Baseline to 8 weeks</time_frame>
      <description>Minutes of sedentary time per day, measured using the activPAL micro4 (mean minutes per day determined by 7-day wear protocol) at baseline and week 8.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in daily step count</measure>
      <time_frame>Baseline to 8 weeks</time_frame>
      <description>Count of steps per day, measured using the activPAL micro4 (mean daily step count determined by 7-day wear protocol) at baseline and week 8.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Health-related quality of life</measure>
      <time_frame>Baseline to 8 weeks</time_frame>
      <description>Change in score on the EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) measured at baseline and week 8</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse event count</measure>
      <time_frame>Count of adverse events at week 8</time_frame>
      <description>Total count of adverse events over the course of the study based on an adverse events questionnaire completed at 8 weeks</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Stroke</condition>
    <condition>Stroke Ischemic</condition>
    <condition>Stroke Hemorrhagic</condition>
    <condition>Stroke Sequelae</condition>
    <arm_group>
      <arm_group_label>duoABLE</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Stroke participant-caregiver duos (dyads) will meet with an occupational therapist 12 times (2x/week for 6 weeks, approximately 30 minutes/session) to apply activity monitoring, activity scheduling, collaborative problem solving, self-assessment, and social interdependence to self-selected activities that aim to increase both dyad members' physical activity levels</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>duoABLE</intervention_name>
      <description>Stroke participant-caregiver duos (dyads) will meet with an occupational therapist 12 times (2x/week for 6 weeks, approximately 30 minutes/session) to apply activity monitoring, activity scheduling, collaborative problem solving, self-assessment, and social interdependence to self-selected activities that aim to increase both dyad members' physical activity levels</description>
      <arm_group_label>duoABLE</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria (Stroke Participants):&#xD;
  &#xD;
            -  Stroke diagnosed more than 6 months ago&#xD;
  &#xD;
            -  Are 18 years of age or older&#xD;
  &#xD;
            -  Report ≥6 hours of sedentary behavior on a typical day OR report engagement in ≤90&#xD;
               minutes of moderate-to-vigorous physical activity in the past week&#xD;
  &#xD;
            -  Reside in a community-based setting&#xD;
  &#xD;
            -  Are mobile within their home, with or without an assistive device and without physical&#xD;
               assistance&#xD;
  &#xD;
            -  Are able to identify an eligible caregiver who will engage in assessments and&#xD;
               intervention.&#xD;
  &#xD;
          Inclusion Criteria (Caregiver Participants):&#xD;
  &#xD;
            -  Are 18 years of age or older&#xD;
  &#xD;
            -  Report ≥6 hours of sedentary behavior on a typical day OR report engagement in ≤90&#xD;
               minutes of moderate-to-vigorous physical activity in the past week&#xD;
  &#xD;
            -  Reside in a community-based setting&#xD;
  &#xD;
            -  Are mobile within their home, with or without an assistive device and without physical&#xD;
               assistance&#xD;
  &#xD;
          Exclusion Criteria (Stroke Participants):&#xD;
  &#xD;
            -  Severe aphasia&#xD;
  &#xD;
            -  Are currently receiving chemotherapy or radiation treatments for cancer&#xD;
  &#xD;
            -  Have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinson's&#xD;
               disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)&#xD;
  &#xD;
            -  Received inpatient treatment for substance use disorder or psychiatric condition&#xD;
               within the past 12 months&#xD;
  &#xD;
            -  Have a history of skin sensitivity related to adhesives&#xD;
  &#xD;
            -  Are pregnant or expecting to become pregnant in the next 2 months&#xD;
  &#xD;
            -  Reside in an institutional setting&#xD;
  &#xD;
            -  Are currently incarcerated&#xD;
  &#xD;
          Exclusion Criteria (Caregiver Participants):&#xD;
  &#xD;
            -  Have a history of skin sensitivity related to adhesives&#xD;
  &#xD;
            -  Are currently receiving chemotherapy or radiation treatments for cancer&#xD;
  &#xD;
            -  Have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinson's&#xD;
               disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)&#xD;
  &#xD;
            -  Received inpatient treatment for substance use disorder or psychiatric condition&#xD;
               within the past 12 months&#xD;
  &#xD;
            -  Are pregnant or expecting to become pregnant in the next 2 months&#xD;
  &#xD;
            -  Reside in an institutional setting&#xD;
  &#xD;
            -  Are currently incarcerated&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Emily A Kringle, PhD, OTR/L</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Minnesota</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Karli Jahnke, MOT, OTR/L</last_name>
      <phone>(612) 626-4046</phone>
      <email>dwell@umn.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>School of Kinesiology, University of Minnesota</name>
        <address>
          <city>Minneapolis</city>
          <state>Minnesota</state>
          <zip>55455</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Karli Jahnke, MOT, OTR/L</last_name>
        <phone>612-626-4046</phone>
        <email>dwell@umn.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>lifestyle</keyword>
    <keyword>physical activity</keyword>
    <keyword>duoABLE</keyword>
    <keyword>ABLE</keyword>
    <keyword>rehabilitation</keyword>
    <keyword>rehab</keyword>
    <keyword>occupational therapy</keyword>
    <keyword>physical therapy</keyword>
    <keyword>stroke</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Hemorrhagic Stroke</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>There are no current plans to share data with other investigators. Upon the completion of the study, a de-identified dataset that includes questionnaire data, raw and processed activPAL data, and transcribed interview data will be created and stored in the DWELL Laboratory at the University of Minnesota. The PI will consider individual requests for data sharing and provide only the necessary de-identified data upon reasonable request, under a University of Minnesota data use agreement.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964400
  org study id: duoABLE
  secondary id: AOTFIRG23KRINGLE
  nct id: NCT05964400
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this intervention study is to test whether a behavioral program that involves
        people with stroke and their caregivers is acceptable, safe, and can promote physically
        active lifestyles using enjoyable activities. Participant duos (person with stroke and their
        caregiver) will be asked to complete assessments at 2 timepoints, wear an activity tracker,
        participate in 12 sessions with an occupational therapist, and complete an interview.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Participant satisfaction
  time frame: Score at week 8
  description: Measured using the Client Satisfaction Questionnaire-8 (CSQ-8)
  measure: Change in activity restrictions
  time frame: Baseline to 8 weeks
  description: Proportion of activities retained assessed at baseline and 8-weeks by the Activity Card Sort 3
  measure: Change in sedentary minutes per day
  time frame: Baseline to 8 weeks
  description: Minutes of sedentary time per day, measured using the activPAL micro4 (mean minutes per day determined by 7-day wear protocol) at baseline and week 8.
  measure: Change in daily step count
  time frame: Baseline to 8 weeks
  description: Count of steps per day, measured using the activPAL micro4 (mean daily step count determined by 7-day wear protocol) at baseline and week 8.
  measure: Change in Health-related quality of life
  time frame: Baseline to 8 weeks
  description: Change in score on the EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) measured at baseline and week 8
  measure: Adverse event count
  time frame: Count of adverse events at week 8
  description: Total count of adverse events over the course of the study based on an adverse events questionnaire completed at 8 weeks
  arm group label: duoABLE
  arm group type: Experimental
  description: Stroke participant-caregiver duos (dyads) will meet with an occupational therapist 12 times (2x/week for 6 weeks, approximately 30 minutes/session) to apply activity monitoring, activity scheduling, collaborative problem solving, self-assessment, and social interdependence to self-selected activities that aim to increase both dyad members' physical activity levels
  intervention type: Behavioral
  intervention name: duoABLE
  description: Stroke participant-caregiver duos (dyads) will meet with an occupational therapist 12 times (2x/week for 6 weeks, approximately 30 minutes/session) to apply activity monitoring, activity scheduling, collaborative problem solving, self-assessment, and social interdependence to self-selected activities that aim to increase both dyad members' physical activity levels
  arm group label: duoABLE
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Emily A Kringle, PhD, OTR/L
  role: Principal Investigator
  affiliation: University of Minnesota
  last name: Karli Jahnke, MOT, OTR/L
  phone: (612) 626-4046
  email: dwell@umn.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Hemorrhagic Stroke
  mesh term: Ischemic Stroke
  sharing ipd: Yes
  ipd description: There are no current plans to share data with other investigators. Upon the completion of the study, a de-identified dataset that includes questionnaire data, raw and processed activPAL data, and transcribed interview data will be created and stored in the DWELL Laboratory at the University of Minnesota. The PI will consider individual requests for data sharing and provide only the necessary de-identified data upon reasonable request, under a University of Minnesota data use agreement.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)