<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/NCT04482400</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00092132</org_study_id>
    <nct_id>NCT04482400</nct_id>
  </id_info>
  <brief_title>Technology Interventions to Improve Outcomes After Knee Replacement</brief_title>
  <official_title>Reducing Sedentary Time Using an Innovative mHealth Intervention Among Total Knee Replacement Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Prisma Health-Midlands</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to examine the effects of two technology interventions on health&#xD;
      outcomes (e.g., physical activity, sedentary behavior, physical function, pain) after knee&#xD;
      replacement at 2 and 5 months .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two 8 week technology interventions will be examined and consist of the use of an app and/or&#xD;
      website and regular calls. Assessments to examine outcomes will be completed at baseline, as&#xD;
      well as at 2 and 5 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2024</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>Change in Objectively Measured (Actigraph) Sedentary Behavior at 2 months</measure>
    <time_frame>2 months - baseline</time_frame>
    <description>change sedentary behavior (&lt;100 counts/minute) measured with Actigraph accelerometers between baseline and 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Objectively Measured (Actigraph) Sedentary Behavior at 5 months</measure>
    <time_frame>5 months - baseline</time_frame>
    <description>change in sedentary behavior (&lt;100 counts/minute) measured with Actigraph accelerometers between baseline and 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Function</measure>
    <time_frame>5 months after surgery</time_frame>
    <description>Six minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in WOMAC Pain Subscale</measure>
    <time_frame>5 months after surgery</time_frame>
    <description>WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total physical activity measured by Actigraph accelerometers</measure>
    <time_frame>5 months after surgery</time_frame>
    <description>objectively measured light, moderate and vigorous activity (&gt;= 100 counts/min) by Actigraph accelerometers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to NEAT!2 calls</measure>
    <time_frame>2 months</time_frame>
    <description>Number of calls completed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to NEAT!2 app</measure>
    <time_frame>2 months</time_frame>
    <description>total days NEAT! app was used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response to NEAT!2 prompts</measure>
    <time_frame>2 months</time_frame>
    <description>percentage of notifications in which a transition from sitting to standing was detected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical function via chair stand test</measure>
    <time_frame>5 months after surgery</time_frame>
    <description>Chair stand test</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in physical function via timed up and go</measure>
    <time_frame>5 months after surgery</time_frame>
    <description>Timed up and go test</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Knee Symptoms - KOOS pain</measure>
    <time_frame>5 months</time_frame>
    <description>KOOS pain subcale (0 indicates extreme problems, 100 no problems)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Knee Symptoms - KOOS symptoms</measure>
    <time_frame>2 months</time_frame>
    <description>KOOS symptoms subcale (0 indicates extreme problems, 100 no problems)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Knee Symptoms - KOOS ADL</measure>
    <time_frame>5 months</time_frame>
    <description>KOOS ADL subcale (0 indicates extreme problems, 100 no problems)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Knee Symptoms - KOOS sport/rec</measure>
    <time_frame>5 months</time_frame>
    <description>KOOS sport/rec subcale (0 indicates extreme problems, 100 no problems)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Knee Symptoms - KOOS QoL</measure>
    <time_frame>5 months</time_frame>
    <description>KOOS QOL subcales (0 indicates extreme problems, 100 no problems)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in knee symptoms via WOMAC</measure>
    <time_frame>5 months</time_frame>
    <description>WOMAC total score (pain, stiffness, and function) - Scores range from 0 (no problems) to 96 (extreme problems)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in sedentary time via activPAL accelerometers</measure>
    <time_frame>5 months</time_frame>
    <description>activPAL accelerometer</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Reported outcomes - Mobility - T-Score</measure>
    <time_frame>5 months</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) - T score of 50 represents average for general population (scores higher than 50 represent better function and mobility)</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Reported outcomes - global health - T-Score</measure>
    <time_frame>5 months</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - T score of 50 represents average for general population (scores higher than 50 represent better health)</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Reported outcomes - sleep disturbance - T-Score</measure>
    <time_frame>5 months</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance - T score of 50 represents average for general population (scores higher than 50 represent worse sleep disturbance)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in habit strength</measure>
    <time_frame>5 months</time_frame>
    <description>adapted self-report habit index</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in sedentary time via SIT-Q</measure>
    <time_frame>5 months</time_frame>
    <description>SIT-Q</description>
  </other_outcome>
  <other_outcome>
    <measure>Weight</measure>
    <time_frame>5 months</time_frame>
    <description>Change in weight</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">92</enrollment>
  <condition>Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>NEAT!2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MyKneeGuide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>NEAT!2</intervention_name>
    <description>8 week sedentary reduction program</description>
    <arm_group_label>NEAT!2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MyKneeGuide</intervention_name>
    <description>8 week surgery recovery education program</description>
    <arm_group_label>MyKneeGuide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be 40-79 years of age&#xD;
&#xD;
          -  Had unilateral knee replacement within last 12 months&#xD;
&#xD;
          -  Have an Android or iOS smartphone that is accessible and near them the majority of the&#xD;
             day&#xD;
&#xD;
          -  Be willing to download the study applications on their smartphone&#xD;
&#xD;
          -  Spend at least 7 hours/day sitting&#xD;
&#xD;
          -  Be English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have any contraindications to activity&#xD;
&#xD;
          -  Have a mobility limiting comorbidity&#xD;
&#xD;
          -  Have a scheduled surgery within the next 6 months&#xD;
&#xD;
          -  Do not have ≥4 days of valid accelerometer (&gt;=10 hours) wear at baseline.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Pellegrini, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Carolina</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ellen Wingard</last_name>
    <phone>803-777-1889</phone>
    <email>ewingard@mailbox.sc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of South Carolina</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine Pellegrini, PhD.</last_name>
      <phone>803-777-0911</phone>
      <email>cpellegrini@sc.edu</email>
    </contact>
    <investigator>
      <last_name>Christine Pellegrini, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of South Carolina</investigator_affiliation>
    <investigator_full_name>Christine A Pellegrini, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified study data will be made available 12 months after the primary manuscript is published.</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>
    <ipd_time_frame>12 months after primary manuscripts are published</ipd_time_frame>
  </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/NCT04482400
org study id: Pro00092132
nct id: NCT04482400
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the effects of two technology interventions on health
      outcomes (e.g., physical activity, sedentary behavior, physical function, pain) after knee
      replacement at 2 and 5 months .
Two 8 week technology interventions will be examined and consist of the use of an app and/or
      website and regular calls. Assessments to examine outcomes will be completed at baseline, as
      well as at 2 and 5 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Objectively Measured (Actigraph) Sedentary Behavior at 2 months
time frame: 2 months - baseline
description: change sedentary behavior (<100 counts/minute) measured with Actigraph accelerometers between baseline and 3 months
measure: Change in Objectively Measured (Actigraph) Sedentary Behavior at 5 months
time frame: 5 months - baseline
description: change in sedentary behavior (<100 counts/minute) measured with Actigraph accelerometers between baseline and 6 months
measure: Change in Physical Function
time frame: 5 months after surgery
description: Six minute walk test
measure: Change in WOMAC Pain Subscale
time frame: 5 months after surgery
description: WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)
measure: Total physical activity measured by Actigraph accelerometers
time frame: 5 months after surgery
description: objectively measured light, moderate and vigorous activity (>= 100 counts/min) by Actigraph accelerometers
measure: Adherence to NEAT!2 calls
time frame: 2 months
description: Number of calls completed
measure: Adherence to NEAT!2 app
time frame: 2 months
description: total days NEAT! app was used
measure: Response to NEAT!2 prompts
time frame: 2 months
description: percentage of notifications in which a transition from sitting to standing was detected
measure: Change in physical function via chair stand test
time frame: 5 months after surgery
description: Chair stand test
measure: Change in physical function via timed up and go
time frame: 5 months after surgery
description: Timed up and go test
measure: Change in Knee Symptoms - KOOS pain
time frame: 5 months
description: KOOS pain subcale (0 indicates extreme problems, 100 no problems)
measure: Change in Knee Symptoms - KOOS symptoms
time frame: 2 months
description: KOOS symptoms subcale (0 indicates extreme problems, 100 no problems)
measure: Change in Knee Symptoms - KOOS ADL
time frame: 5 months
description: KOOS ADL subcale (0 indicates extreme problems, 100 no problems)
measure: Change in Knee Symptoms - KOOS sport/rec
time frame: 5 months
description: KOOS sport/rec subcale (0 indicates extreme problems, 100 no problems)
measure: Change in Knee Symptoms - KOOS QoL
time frame: 5 months
description: KOOS QOL subcales (0 indicates extreme problems, 100 no problems)
measure: Change in knee symptoms via WOMAC
time frame: 5 months
description: WOMAC total score (pain, stiffness, and function) - Scores range from 0 (no problems) to 96 (extreme problems)
measure: Change in sedentary time via activPAL accelerometers
time frame: 5 months
description: activPAL accelerometer
measure: Patient Reported outcomes - Mobility - T-Score
time frame: 5 months
description: Patient-Reported Outcomes Measurement Information System (PROMIS) - T score of 50 represents average for general population (scores higher than 50 represent better function and mobility)
measure: Patient Reported outcomes - global health - T-Score
time frame: 5 months
description: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - T score of 50 represents average for general population (scores higher than 50 represent better health)
measure: Patient Reported outcomes - sleep disturbance - T-Score
time frame: 5 months
description: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance - T score of 50 represents average for general population (scores higher than 50 represent worse sleep disturbance)
measure: Change in habit strength
time frame: 5 months
description: adapted self-report habit index
measure: Change in sedentary time via SIT-Q
time frame: 5 months
description: SIT-Q
measure: Weight
time frame: 5 months
description: Change in weight
arm group label: NEAT!2
arm group type: Experimental
description: Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
arm group label: MyKneeGuide
arm group type: Active Comparator
description: Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
intervention type: Behavioral
intervention name: NEAT!2
description: 8 week sedentary reduction program
arm group label: NEAT!2
intervention type: Behavioral
intervention name: MyKneeGuide
description: 8 week surgery recovery education program
arm group label: MyKneeGuide
criteria: 
gender: All
minimum age: 40 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christine Pellegrini, PhD
role: Principal Investigator
affiliation: University of South Carolina
last name: Ellen Wingard
phone: 803-777-1889
email: ewingard@mailbox.sc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of South Carolina
investigator full name: Christine A Pellegrini, PhD
investigator title: Assistant Professor
sharing ipd: Yes
ipd description: De-identified study data will be made available 12 months after the primary manuscript is published.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: 12 months after primary manuscripts are published