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/NCT06028334</url>
    </required_header>
    <id_info>
      <org_study_id>iRISID-2023-1533</org_study_id>
      <nct_id>NCT06028334</nct_id>
    </id_info>
    <brief_title>GetUp&amp;Go: A Randomized Controlled Trial of an Intervention to Enhance Physical Activity After TBI</brief_title>
    <official_title>GetUp&amp;Go: A Randomized Controlled Trial of a Theory-Based Intervention to Enhance Physical Activity in Chronic, Moderate-Severe Traumatic Brain Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Albert Einstein Healthcare Network</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Disability, Independent Living, and Rehabilitation Research</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>Albert Einstein Healthcare Network</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 clinical trial is to evaluate GetUp&amp;Go, a program for promoting increased&#xD;
        physical activity in individuals at least 6 months post moderate-to-severe traumatic brain&#xD;
        injury. GetUp&amp;Go is a remotely delivered 10-week program that includes one-on-one sessions&#xD;
        with a therapist and a mobile health application (RehaBot).&#xD;
  &#xD;
        The main question is whether participants in the 10-week GetUp&amp;Go program increase their&#xD;
        physical activity, and exhibit associated benefits in mental and physical health, relative to&#xD;
        those who are put on a waitlist.&#xD;
  &#xD;
          -  Question 1: Do participants who receive immediate treatment with GetUp&amp;Go show more&#xD;
             increased physical activity, measured by accelerometer activity counts per day, and&#xD;
             improve more on secondary outcomes, such as self-reported physical activity, emotional&#xD;
             function, fatigue, sleep, pain, and health-related quality of life, compared to their&#xD;
             baseline, relative to those who are put on a waitlist?&#xD;
  &#xD;
          -  Question 2: Do participants who have continued access to the mobile health component of&#xD;
             the intervention, RehaBot, show better maintenance of physical activity gains compared&#xD;
             to those who no longer have access to RehaBot?&#xD;
  &#xD;
          -  Question 3: Are individual participant characteristics associated with participants'&#xD;
             response to the treatment program?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators will conduct a Randomized Controlled Trial (RCT) of a novel, remotely&#xD;
        delivered physical activity (PA) promotion program, called GetUp&amp;Go-a name selected by focus&#xD;
        group participants with moderate-to-severe traumatic brain injury (msTBI). It will be&#xD;
        theoretically based, use objective measurement of PA as a primary outcome, and incorporate&#xD;
        varied types and amounts of home- and neighborhood-based PA and ways to reduce sedentary&#xD;
        behavior, according to participant preferences. Moreover, using a 2-phase design as described&#xD;
        below, the investigators will test a method for enhancing longer-term gains in PA using&#xD;
        mobile technology, in addition to gains acquired during the first phase of intervention.&#xD;
  &#xD;
        Trial design. Participants will undergo baseline testing (T1) and will then be randomized 1:1&#xD;
        to either immediate treatment in GetUp&amp;Go (IT) or waitlist (WL) for 10 weeks. After testing&#xD;
        for the primary outcome (T2), the waitlist group will receive GetUp&amp;Go for 10 weeks followed&#xD;
        by a T2b evaluation for that group. This phase is called the &quot;A phase&quot;, for Acquisition.&#xD;
  &#xD;
        Following completion of the GetUp&amp;Go intervention, all participants-regardless of initial&#xD;
        group allocation-will be randomized 1:1 to one of two conditions for an additional 10 weeks,&#xD;
        the &quot;Follow-Through&quot; (FT) phase. Half of participants will be randomized to the RehaBot&#xD;
        condition (RB), which provides continued use of the chatbot to support individualized PA&#xD;
        plans, but with no further therapist contact. Participants in the No RehaBot (No RB)&#xD;
        condition will not have access to the chatbot. The final evaluation, T3, will occur after the&#xD;
        10-week Follow-Through phase.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 18, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2027</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>
      <intervention_model_description>This is a waitlist controlled randomized trial. All participants will receive the GetUp&amp;Go treatment program. Participants will be randomly assigned with a 50% chance of either receiving immediate treatment (IT) with the 10-week program, or going on a 10-week waitlist, after which they will start the GetUp&amp;Go program.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>This project will use masked outcome assessment, with special precautions taken to prevent inadvertent unmasking. These include a &quot;script&quot; reminding participants not to discuss any of their experiences in the trial. Any instances of inadvertent unmasking will be recorded for later analysis of their influence.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Average activity counts/minute</measure>
      <time_frame>Baseline</time_frame>
      <description>Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Average activity counts/minute</measure>
      <time_frame>10 weeks after initial randomization</time_frame>
      <description>Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Average activity counts/minute</measure>
      <time_frame>10 weeks after completing GetUp&amp;Go intervention</time_frame>
      <description>Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percent (%) time sedentary</measure>
      <time_frame>Baseline</time_frame>
      <description>Actigraphy derived percent time sedentary from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent (%) time sedentary</measure>
      <time_frame>10 weeks after initial randomization</time_frame>
      <description>Actigraphy derived percent time sedentary from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent (%) time sedentary</measure>
      <time_frame>10 weeks after completing GetUp&amp;Go intervention</time_frame>
      <description>Actigraphy derived percent time sedentary from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent (%) time engaged in moderate-vigorous physical activity (MVPA)</measure>
      <time_frame>Baseline</time_frame>
      <description>Actigraphy derived percent time engaged in MVPA from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent (%) time engaged in moderate-vigorous physical activity (MVPA)</measure>
      <time_frame>10 weeks after initial randomization</time_frame>
      <description>Actigraphy derived percent time engaged in MVPA from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent (%) time engaged in moderate-vigorous physical activity (MVPA)</measure>
      <time_frame>10 weeks after completing GetUp&amp;Go intervention</time_frame>
      <description>Actigraphy derived percent time engaged in MVPA from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average daily step count</measure>
      <time_frame>Baseline</time_frame>
      <description>Actigraphy derived average daily step count from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average daily step count</measure>
      <time_frame>10 weeks after initial randomization</time_frame>
      <description>Actigraphy derived average daily step count from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average daily step count</measure>
      <time_frame>10 weeks after completing GetUp&amp;Go intervention</time_frame>
      <description>Actigraphy derived average daily step count from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-reported PA</measure>
      <time_frame>Baseline</time_frame>
      <description>Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-reported PA</measure>
      <time_frame>10 weeks after initial randomization</time_frame>
      <description>Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-reported PA</measure>
      <time_frame>10 weeks after completing GetUp&amp;Go intervention</time_frame>
      <description>Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emotional function</measure>
      <time_frame>Baseline</time_frame>
      <description>Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emotional function</measure>
      <time_frame>10 weeks after initial randomization</time_frame>
      <description>Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emotional function</measure>
      <time_frame>10 weeks after completing GetUp&amp;Go intervention</time_frame>
      <description>Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue</measure>
      <time_frame>Baseline</time_frame>
      <description>Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue</measure>
      <time_frame>10 weeks after initial randomization</time_frame>
      <description>Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue</measure>
      <time_frame>10 weeks after completing GetUp&amp;Go intervention</time_frame>
      <description>Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep Quality</measure>
      <time_frame>Baseline</time_frame>
      <description>Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep Quality</measure>
      <time_frame>10 weeks after initial randomization</time_frame>
      <description>Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep Quality</measure>
      <time_frame>10 weeks after completing GetUp&amp;Go intervention</time_frame>
      <description>Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective pain</measure>
      <time_frame>Baseline</time_frame>
      <description>Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective pain</measure>
      <time_frame>10 weeks after initial randomization</time_frame>
      <description>Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective pain</measure>
      <time_frame>10 weeks after completing GetUp&amp;Go intervention</time_frame>
      <description>Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related Quality of Life</measure>
      <time_frame>Baseline</time_frame>
      <description>Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related Quality of Life</measure>
      <time_frame>10 weeks after initial randomization</time_frame>
      <description>Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related Quality of Life</measure>
      <time_frame>10 weeks after completing GetUp&amp;Go intervention</time_frame>
      <description>Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Traumatic Brain Injury</condition>
    <arm_group>
      <arm_group_label>Immediate Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The 10-week GetUp&amp;Go intervention will be delivered entirely remotely, with 2 weekly sessions with a therapist delivered over videoconference (Zoom for Healthcare) followed by 3 sessions in weeks 3, 5, and 8, over Zoom or phone according to participant preference.&#xD;
  The overall goal of the intervention is to develop and support a personalized plan to increase physical activity and decrease sedentary behavior, in concert with the unique capabilities, opportunities, and motivational factors of each participant. In session 2 and thereafter, RehaBot will be supplied to participants to deliver therapeutic ingredients to supplement those provided by the therapist.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>A 10-week waitlist with baseline and outcome assessment, followed by receipt of the full GetUp&amp;Go program.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>GetUp&amp;Go</intervention_name>
      <description>A behavioral treatment combining personalized activity planning and a mobile health application for supporting adherence to activity plans.</description>
      <arm_group_label>Immediate Treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>GetUp&amp;Go with 10-Week Delay</intervention_name>
      <description>No assigned treatment during the waitlist phase. Participants in the WL group will be offered the GetUp&amp;Go intervention, which combines personalized activity planning and a mobile health application, after collection of the primary outcome measure.</description>
      <arm_group_label>Waitlist</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18&#xD;
  &#xD;
            -  TBI (open or closed), sustained at least 6 months prior to enrollment, of at least&#xD;
               complicated-mild/moderate severity as evidenced by loss or alteration of consciousness&#xD;
               ≥ 30 minutes; and/or post-traumatic amnesia (PTA) ≥ 24 hours, not due to&#xD;
               intoxication/sedation and documented prospectively from the injury; and/or positive&#xD;
               neuroimaging findings consistent with TBI&#xD;
  &#xD;
            -  Fully weight bearing on lower limbs and able to walk indoors and outdoors without the&#xD;
               assistance of another person&#xD;
  &#xD;
            -  Cognitively able to participate in treatment as judged by ability to travel&#xD;
               independently within the community&#xD;
  &#xD;
            -  Able to communicate adequately in English for participation in the treatment protocols&#xD;
  &#xD;
            -  Informed consent given by participant&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Contraindications to increasing PA as judged by study physician, using an exam based&#xD;
               on published screening tools&#xD;
  &#xD;
            -  Medical or psychiatric instability, including current psychosis or severe uncontrolled&#xD;
               substance misuse, as assessed using items from the SCID/MINI/ASSIST, or suicidal&#xD;
               ideation with intent or plan, as assessed by the Columbia-Suicide Severity Rating&#xD;
               Scale, screening version&#xD;
  &#xD;
            -  Significant physical or intellectual disability predating the TBI&#xD;
  &#xD;
            -  Neurodegenerative disorder, e.g., Parkinson's disease&#xD;
  &#xD;
            -  Insufficiently inactive, i.e., reporting &gt; 23 weekly moderate/vigorous activity units&#xD;
               on the Godin Leisure-Time Exercise Questionnaire&#xD;
  &#xD;
            -  Planned surgery or other hospitalization during the succeeding 9 months&#xD;
  &#xD;
            -  Physical or sensory disability (e.g., blindness; severe bimanual incoordination) that&#xD;
               prevents use of a smartphone&#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>Amanda Rabinowitz, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Albert Einstein Healthcare Network</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Amanda Rabinowitz, PhD</last_name>
      <phone>215 663-6526</phone>
      <email>amanda.rabinowitz@jefferson.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lauren Krasucki, DPT, MPH</last_name>
      <email>lauren.krasucki@jefferson.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Moss Rehabilitation Research Institute</name>
        <address>
          <city>Elkins Park</city>
          <state>Pennsylvania</state>
          <zip>19027</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Albert Einstein Healthcare Network</investigator_affiliation>
      <investigator_full_name>Amanda Rabinowitz</investigator_full_name>
      <investigator_title>Institute Scientist</investigator_title>
    </responsible_party>
    <keyword>physical activity</keyword>
    <keyword>mobile health</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Brain Injuries, Traumatic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All data collected for this trial will be submitted the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system.&#xD;
  The data submitted to FITBIR will be fully de-identified and contain the Global Unique Identifier (GUID). The investigators will assign GUIDs to cases using the methodology recommended by FITBIR. If it is not possible to assign a GUID to cases, a Pseudo-GUID will be assigned. All variables will be converted to the TBI Common Data Elements (CDEs), to the extent possible; otherwise variables that do not map to the TBI CDEs will be submitted as Unique Data Elements (UDEs).</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>All data from this trial will be submitted to FITBIR within one year of the completion of the award, per the FITBIR submission schedule for clinical trials.</ipd_time_frame>
      <ipd_access_criteria>Projects must be specified for research purposes only (not commercial) with the intention to enhance knowledge for the benefit of human health.&#xD;
  Individuals requesting access must have a medical or scientific degree or position relevant for the request.&#xD;
  Individuals must be affiliated with a research, industry, or non-profit institution/business/organization.&#xD;
  All data access requests must be signed by an individual legally authorized to sign on behalf of the institution/business/organization.</ipd_access_criteria>
      <ipd_url>https://fitbir.nih.gov/</ipd_url>
    </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/NCT06028334
  org study id: iRISID-2023-1533
  nct id: NCT06028334
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate GetUp&Go, a program for promoting increased
        physical activity in individuals at least 6 months post moderate-to-severe traumatic brain
        injury. GetUp&Go is a remotely delivered 10-week program that includes one-on-one sessions
        with a therapist and a mobile health application (RehaBot).
  
        The main question is whether participants in the 10-week GetUp&Go program increase their
        physical activity, and exhibit associated benefits in mental and physical health, relative to
        those who are put on a waitlist.
  
          -  Question 1: Do participants who receive immediate treatment with GetUp&Go show more
             increased physical activity, measured by accelerometer activity counts per day, and
             improve more on secondary outcomes, such as self-reported physical activity, emotional
             function, fatigue, sleep, pain, and health-related quality of life, compared to their
             baseline, relative to those who are put on a waitlist?
  
          -  Question 2: Do participants who have continued access to the mobile health component of
             the intervention, RehaBot, show better maintenance of physical activity gains compared
             to those who no longer have access to RehaBot?
  
          -  Question 3: Are individual participant characteristics associated with participants'
             response to the treatment program?
  The investigators will conduct a Randomized Controlled Trial (RCT) of a novel, remotely
        delivered physical activity (PA) promotion program, called GetUp&Go-a name selected by focus
        group participants with moderate-to-severe traumatic brain injury (msTBI). It will be
        theoretically based, use objective measurement of PA as a primary outcome, and incorporate
        varied types and amounts of home- and neighborhood-based PA and ways to reduce sedentary
        behavior, according to participant preferences. Moreover, using a 2-phase design as described
        below, the investigators will test a method for enhancing longer-term gains in PA using
        mobile technology, in addition to gains acquired during the first phase of intervention.
  
        Trial design. Participants will undergo baseline testing (T1) and will then be randomized 1:1
        to either immediate treatment in GetUp&Go (IT) or waitlist (WL) for 10 weeks. After testing
        for the primary outcome (T2), the waitlist group will receive GetUp&Go for 10 weeks followed
        by a T2b evaluation for that group. This phase is called the "A phase", for Acquisition.
  
        Following completion of the GetUp&Go intervention, all participants-regardless of initial
        group allocation-will be randomized 1:1 to one of two conditions for an additional 10 weeks,
        the "Follow-Through" (FT) phase. Half of participants will be randomized to the RehaBot
        condition (RB), which provides continued use of the chatbot to support individualized PA
        plans, but with no further therapist contact. Participants in the No RehaBot (No RB)
        condition will not have access to the chatbot. The final evaluation, T3, will occur after the
        10-week Follow-Through phase.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a waitlist controlled randomized trial. All participants will receive the GetUp&Go treatment program. Participants will be randomly assigned with a 50% chance of either receiving immediate treatment (IT) with the 10-week program, or going on a 10-week waitlist, after which they will start the GetUp&Go program.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: This project will use masked outcome assessment, with special precautions taken to prevent inadvertent unmasking. These include a "script" reminding participants not to discuss any of their experiences in the trial. Any instances of inadvertent unmasking will be recorded for later analysis of their influence.
  measure: Average activity counts/minute
  time frame: Baseline
  description: Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
  measure: Average activity counts/minute
  time frame: 10 weeks after initial randomization
  description: Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
  measure: Average activity counts/minute
  time frame: 10 weeks after completing GetUp&Go intervention
  description: Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
  measure: Percent (%) time sedentary
  time frame: Baseline
  description: Actigraphy derived percent time sedentary from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
  measure: Percent (%) time sedentary
  time frame: 10 weeks after initial randomization
  description: Actigraphy derived percent time sedentary from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
  measure: Percent (%) time sedentary
  time frame: 10 weeks after completing GetUp&Go intervention
  description: Actigraphy derived percent time sedentary from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
  measure: Percent (%) time engaged in moderate-vigorous physical activity (MVPA)
  time frame: Baseline
  description: Actigraphy derived percent time engaged in MVPA from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
  measure: Percent (%) time engaged in moderate-vigorous physical activity (MVPA)
  time frame: 10 weeks after initial randomization
  description: Actigraphy derived percent time engaged in MVPA from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
  measure: Percent (%) time engaged in moderate-vigorous physical activity (MVPA)
  time frame: 10 weeks after completing GetUp&Go intervention
  description: Actigraphy derived percent time engaged in MVPA from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
  measure: Average daily step count
  time frame: Baseline
  description: Actigraphy derived average daily step count from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
  measure: Average daily step count
  time frame: 10 weeks after initial randomization
  description: Actigraphy derived average daily step count from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
  measure: Average daily step count
  time frame: 10 weeks after completing GetUp&Go intervention
  description: Actigraphy derived average daily step count from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
  measure: Self-reported PA
  time frame: Baseline
  description: Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity)
  measure: Self-reported PA
  time frame: 10 weeks after initial randomization
  description: Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity)
  measure: Self-reported PA
  time frame: 10 weeks after completing GetUp&Go intervention
  description: Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity)
  measure: Emotional function
  time frame: Baseline
  description: Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)
  measure: Emotional function
  time frame: 10 weeks after initial randomization
  description: Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)
  measure: Emotional function
  time frame: 10 weeks after completing GetUp&Go intervention
  description: Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)
  measure: Fatigue
  time frame: Baseline
  description: Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)
  measure: Fatigue
  time frame: 10 weeks after initial randomization
  description: Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)
  measure: Fatigue
  time frame: 10 weeks after completing GetUp&Go intervention
  description: Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)
  measure: Sleep Quality
  time frame: Baseline
  description: Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)
  measure: Sleep Quality
  time frame: 10 weeks after initial randomization
  description: Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)
  measure: Sleep Quality
  time frame: 10 weeks after completing GetUp&Go intervention
  description: Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)
  measure: Subjective pain
  time frame: Baseline
  description: Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)
  measure: Subjective pain
  time frame: 10 weeks after initial randomization
  description: Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)
  measure: Subjective pain
  time frame: 10 weeks after completing GetUp&Go intervention
  description: Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)
  measure: Health-related Quality of Life
  time frame: Baseline
  description: Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life)
  measure: Health-related Quality of Life
  time frame: 10 weeks after initial randomization
  description: Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life)
  measure: Health-related Quality of Life
  time frame: 10 weeks after completing GetUp&Go intervention
  description: Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life)
  arm group label: Immediate Treatment
  arm group type: Experimental
  description: The 10-week GetUp&Go intervention will be delivered entirely remotely, with 2 weekly sessions with a therapist delivered over videoconference (Zoom for Healthcare) followed by 3 sessions in weeks 3, 5, and 8, over Zoom or phone according to participant preference.
  The overall goal of the intervention is to develop and support a personalized plan to increase physical activity and decrease sedentary behavior, in concert with the unique capabilities, opportunities, and motivational factors of each participant. In session 2 and thereafter, RehaBot will be supplied to participants to deliver therapeutic ingredients to supplement those provided by the therapist.
  arm group label: Waitlist
  arm group type: Placebo Comparator
  description: A 10-week waitlist with baseline and outcome assessment, followed by receipt of the full GetUp&Go program.
  intervention type: Behavioral
  intervention name: GetUp&Go
  description: A behavioral treatment combining personalized activity planning and a mobile health application for supporting adherence to activity plans.
  arm group label: Immediate Treatment
  intervention type: Behavioral
  intervention name: GetUp&Go with 10-Week Delay
  description: No assigned treatment during the waitlist phase. Participants in the WL group will be offered the GetUp&Go intervention, which combines personalized activity planning and a mobile health application, after collection of the primary outcome measure.
  arm group label: Waitlist
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Amanda Rabinowitz, PhD
  role: Principal Investigator
  affiliation: Albert Einstein Healthcare Network
  last name: Amanda Rabinowitz, PhD
  phone: 215 663-6526
  email: amanda.rabinowitz@jefferson.edu
  last name: Lauren Krasucki, DPT, MPH
  email: lauren.krasucki@jefferson.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Albert Einstein Healthcare Network
  investigator full name: Amanda Rabinowitz
  investigator title: Institute Scientist
  mesh term: Brain Injuries
  mesh term: Brain Injuries, Traumatic
  sharing ipd: Yes
  ipd description: All data collected for this trial will be submitted the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system.
  The data submitted to FITBIR will be fully de-identified and contain the Global Unique Identifier (GUID). The investigators will assign GUIDs to cases using the methodology recommended by FITBIR. If it is not possible to assign a GUID to cases, a Pseudo-GUID will be assigned. All variables will be converted to the TBI Common Data Elements (CDEs), to the extent possible; otherwise variables that do not map to the TBI CDEs will be submitted as Unique Data Elements (UDEs).
  ipd info type: Study Protocol
  ipd time frame: All data from this trial will be submitted to FITBIR within one year of the completion of the award, per the FITBIR submission schedule for clinical trials.
  ipd access criteria: Projects must be specified for research purposes only (not commercial) with the intention to enhance knowledge for the benefit of human health.
  Individuals requesting access must have a medical or scientific degree or position relevant for the request.
  Individuals must be affiliated with a research, industry, or non-profit institution/business/organization.
  All data access requests must be signed by an individual legally authorized to sign on behalf of the institution/business/organization.
  ipd url: https://fitbir.nih.gov/