<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/NCT03037619</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00063842</org_study_id>
    <nct_id>NCT03037619</nct_id>
  </id_info>
  <brief_title>Fitbit and Social Support in Knee Replacement Patients &amp; Buddies</brief_title>
  <official_title>Influence of Wearable Activity Monitors and Social Support on Physical Activity After Knee Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of South Carolina</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>
      Patients undergoing knee replacement typically report improved health-related quality of&#xD;
      life, increased physical function, and reduced pain. Despite these improvements, physical&#xD;
      activity levels remain unchanged, or only minimally increase from pre-operative levels, yet&#xD;
      do not reach the same level of activity observed among healthy populations. Knee replacement&#xD;
      patients often expect their activity levels and function to improve following surgery, but&#xD;
      the majority of patients' activity levels 5 years post-operatively did not meet their&#xD;
      pre-operative expectations. Even though improvements are observed in pain and function,&#xD;
      reasons for the maintenance of low levels of activity are unknown. Technology has the&#xD;
      potential to increase physical activity levels in these patients, particularly as 81% of knee&#xD;
      replacement patients in our recent study had a smartphone, and 40% were willing to wear a&#xD;
      wrist-worn physical activity monitor. As the average age of knee replacement continues to&#xD;
      decrease, we anticipate that the percent of patients with a smartphone and willingness to&#xD;
      wear an activity monitor will increase. In addition to technology, social support is&#xD;
      associated with greater outcomes following knee replacement. Thus, wearing a wrist-worn&#xD;
      physical activity monitor and providing additional opportunities for social support via the&#xD;
      technology may increase physical activity levels in these patients. The current pilot study&#xD;
      aims to gain preliminary data on the influence of wearables and social support on physical&#xD;
      activity in knee replacement patients following surgery. Specifically, we aim to recruit 20&#xD;
      patients who will be randomized to one of two conditions: Fitbit vs. Fitbit+Support.&#xD;
      Participants in the Fitbit group will receive a Fitbit and be encouraged to wear it for 4&#xD;
      months. Participants in the Fitbit+Support group will be asked to identify a &quot;buddy.&quot; Both&#xD;
      the participant and &quot;buddy&quot; will be given a Fitbit and they will be asked to friend each&#xD;
      other via Fitbit and wear the monitor for 4 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2017</start_date>
  <completion_date type="Actual">November 10, 2018</completion_date>
  <primary_completion_date type="Actual">November 10, 2018</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Moderate/Vigorous Intensity Physical Activity</measure>
    <time_frame>4 months</time_frame>
    <description>Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Social Support</measure>
    <time_frame>4 months</time_frame>
    <description>Social Support &amp; Exercise Survey - Family score (sum items 11 - 16 and 20 - 23); Scores can range between 10-50, with a higher score indicating more support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Satisfied With the Fitbit</measure>
    <time_frame>4 months</time_frame>
    <description>Acceptability of the Fitbit (% satisfied with Fitbit)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fitbit Engagement</measure>
    <time_frame>4 months</time_frame>
    <description>Percentage of days Fitbit was worn</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Arthroplasty, Replacement, Knee</condition>
  <arm_group>
    <arm_group_label>Fitbit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fitbit+Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fitbit</intervention_name>
    <description>Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months</description>
    <arm_group_label>Fitbit</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fitbit+Support</intervention_name>
    <description>Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.</description>
    <arm_group_label>Fitbit+Support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Knee replacement patients must (1) have had a knee replacement in the last 12 months;&#xD;
             (2) have a computer or smartphone compatible with Fitbit, (3) be English speaking, (4)&#xD;
             willing to wear the Fitbit for 4 months, and (5) have a &quot;buddy&quot; willing to&#xD;
             participate.&#xD;
&#xD;
          -  Patient buddies must: (1) have a computer or smartphone compatible with Fitbit, (2) be&#xD;
             English speaking, and (3) willing to wear the Fitbit for 4 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Knee replacement patients will be excluded if they have another knee replacement&#xD;
             scheduled within the next 4 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <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>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <results_first_submitted>July 25, 2019</results_first_submitted>
  <results_first_submitted_qc>September 13, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 16, 2019</results_first_posted>
  <last_update_submitted>September 13, 2019</last_update_submitted>
  <last_update_submitted_qc>September 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2019</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>Research Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03037619/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fitbit</title>
          <description>Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.&#xD;
Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months</description>
        </group>
        <group group_id="P2">
          <title>Fitbit+Support</title>
          <description>Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.&#xD;
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="15">8 participants and 7 buddies</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="14">7 participants and 7 buddies</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>&quot;Buddy participants&quot; (n=7) were excluded from baseline analyses. Only knee replacement participants were included (n=8).</population>
      <group_list>
        <group group_id="B1">
          <title>Fitbit</title>
          <description>Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.&#xD;
Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months</description>
        </group>
        <group group_id="B2">
          <title>Fitbit&amp;Support</title>
          <description>Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.&#xD;
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.6" spread="7.6"/>
                    <measurement group_id="B2" value="62.5" spread="8.5"/>
                    <measurement group_id="B3" value="60.6" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Moderate/Vigorous Intensity Physical Activity</title>
        <description>Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit</description>
        <time_frame>4 months</time_frame>
        <population>&quot;Buddy participants&quot; (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses</population>
        <group_list>
          <group group_id="O1">
            <title>Fitbit</title>
            <description>Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.&#xD;
Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months</description>
          </group>
          <group group_id="O2">
            <title>Fitbit+Support</title>
            <description>Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.&#xD;
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Moderate/Vigorous Intensity Physical Activity</title>
          <description>Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit</description>
          <population>&quot;Buddy participants&quot; (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses</population>
          <units>minutes/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.9" spread="28.4"/>
                    <measurement group_id="O2" value="33.1" spread="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Social Support</title>
        <description>Social Support &amp; Exercise Survey - Family score (sum items 11 - 16 and 20 - 23); Scores can range between 10-50, with a higher score indicating more support</description>
        <time_frame>4 months</time_frame>
        <population>&quot;Buddy participants&quot; (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses</population>
        <group_list>
          <group group_id="O1">
            <title>Fitbit</title>
            <description>Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.&#xD;
Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months</description>
          </group>
          <group group_id="O2">
            <title>Fitbit+Support</title>
            <description>Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.&#xD;
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Social Support</title>
          <description>Social Support &amp; Exercise Survey - Family score (sum items 11 - 16 and 20 - 23); Scores can range between 10-50, with a higher score indicating more support</description>
          <population>&quot;Buddy participants&quot; (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.6" spread="7.9"/>
                    <measurement group_id="O2" value="25.0" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Satisfied With the Fitbit</title>
        <description>Acceptability of the Fitbit (% satisfied with Fitbit)</description>
        <time_frame>4 months</time_frame>
        <population>&quot;Buddy participants&quot; (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses</population>
        <group_list>
          <group group_id="O1">
            <title>Fitbit</title>
            <description>Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.&#xD;
Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months</description>
          </group>
          <group group_id="O2">
            <title>Fitbit+Support</title>
            <description>Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.&#xD;
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Satisfied With the Fitbit</title>
          <description>Acceptability of the Fitbit (% satisfied with Fitbit)</description>
          <population>&quot;Buddy participants&quot; (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fitbit Engagement</title>
        <description>Percentage of days Fitbit was worn</description>
        <time_frame>4 months</time_frame>
        <population>&quot;Buddy participants&quot; (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses</population>
        <group_list>
          <group group_id="O1">
            <title>Fitbit</title>
            <description>Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.&#xD;
Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months</description>
          </group>
          <group group_id="O2">
            <title>Fitbit+Support</title>
            <description>Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.&#xD;
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Fitbit Engagement</title>
          <description>Percentage of days Fitbit was worn</description>
          <population>&quot;Buddy participants&quot; (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses</population>
          <units>Percentage of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.9" spread="13.2"/>
                    <measurement group_id="O2" value="99.3" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 months</time_frame>
      <desc>This study was classified as minimal risk to participants.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fitbit</title>
          <description>Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.&#xD;
Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months</description>
        </group>
        <group group_id="E2">
          <title>Fitbit+Support</title>
          <description>Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.&#xD;
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to &quot;Friend&quot; each other on Fitbit and encouraged to wear the monitor over the next 4 months.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Christine Pellegrini</name_or_title>
      <organization>University of South Carolina</organization>
      <phone>803-777-0911</phone>
      <email>cpellegrini@sc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03037619
org study id: Pro00063842
nct id: NCT03037619
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients undergoing knee replacement typically report improved health-related quality of
      life, increased physical function, and reduced pain. Despite these improvements, physical
      activity levels remain unchanged, or only minimally increase from pre-operative levels, yet
      do not reach the same level of activity observed among healthy populations. Knee replacement
      patients often expect their activity levels and function to improve following surgery, but
      the majority of patients' activity levels 5 years post-operatively did not meet their
      pre-operative expectations. Even though improvements are observed in pain and function,
      reasons for the maintenance of low levels of activity are unknown. Technology has the
      potential to increase physical activity levels in these patients, particularly as 81% of knee
      replacement patients in our recent study had a smartphone, and 40% were willing to wear a
      wrist-worn physical activity monitor. As the average age of knee replacement continues to
      decrease, we anticipate that the percent of patients with a smartphone and willingness to
      wear an activity monitor will increase. In addition to technology, social support is
      associated with greater outcomes following knee replacement. Thus, wearing a wrist-worn
      physical activity monitor and providing additional opportunities for social support via the
      technology may increase physical activity levels in these patients. The current pilot study
      aims to gain preliminary data on the influence of wearables and social support on physical
      activity in knee replacement patients following surgery. Specifically, we aim to recruit 20
      patients who will be randomized to one of two conditions: Fitbit vs. Fitbit+Support.
      Participants in the Fitbit group will receive a Fitbit and be encouraged to wear it for 4
      months. Participants in the Fitbit+Support group will be asked to identify a "buddy." Both
      the participant and "buddy" will be given a Fitbit and they will be asked to friend each
      other via Fitbit and wear the monitor for 4 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Moderate/Vigorous Intensity Physical Activity
time frame: 4 months
description: Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit
measure: Social Support
time frame: 4 months
description: Social Support & Exercise Survey - Family score (sum items 11 - 16 and 20 - 23); Scores can range between 10-50, with a higher score indicating more support
measure: Percentage of Participants Satisfied With the Fitbit
time frame: 4 months
description: Acceptability of the Fitbit (% satisfied with Fitbit)
measure: Fitbit Engagement
time frame: 4 months
description: Percentage of days Fitbit was worn
arm group label: Fitbit
arm group type: Experimental
description: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.
arm group label: Fitbit+Support
arm group type: Experimental
description: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
intervention type: Behavioral
intervention name: Fitbit
description: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months
arm group label: Fitbit
intervention type: Behavioral
intervention name: Fitbit+Support
description: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
arm group label: Fitbit+Support
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of South Carolina
investigator full name: Christine A Pellegrini, PhD
investigator title: Research Assistant Professor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 