<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/NCT03780400</url>
  </required_header>
  <id_info>
    <org_study_id>18-0877</org_study_id>
    <secondary_id>1R21AG056568</secondary_id>
    <nct_id>NCT03780400</nct_id>
  </id_info>
  <brief_title>Physical Activity Pathway for Patients With Osteoarthritis in Primary Care (OA-PCP)</brief_title>
  <official_title>Physical Activity Pathway for Patients With Osteoarthritis in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</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>
      This is a multi-phase study that will develop and test an osteoarthritis (OA) primary care&#xD;
      Physical activity Care Pathway (OA-PCP), a scalable intervention that includes: 1) a&#xD;
      practical process for physical inactivity screening in primary care, 2) a brief, tailored&#xD;
      physical activity (PA) counseling intervention via telephone, 3) connection of patients with&#xD;
      community programs and other resources to support PA, and 4) follow-up with patients to&#xD;
      deliver additional appropriate counseling and referrals to PA resources.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a single group pilot trial of the OA-PCP. The feasibility and&#xD;
      acceptability of the OA-PCP will be assessed among n=60 patients with hip and knee OA in two&#xD;
      primary care clinics. All patients in the trial will participate in the OA-PCP and will&#xD;
      complete assessments at baseline and 4-month follow-up. Feasibility metrics will include&#xD;
      rates of recruitment, intervention engagement and retention; acceptability will be assessed&#xD;
      from both patients and health care providers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week</measure>
    <time_frame>Baseline, Month 4 (Follow-up)</time_frame>
    <description>Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 4 for Steps Per Day</measure>
    <time_frame>Baseline, Month 4 (Follow-up)</time_frame>
    <description>Step counts were measured via an accelerometer device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 4 for Minutes of Sedentary Activity</measure>
    <time_frame>Baseline, Month 4 (Follow-up)</time_frame>
    <description>Minutes of sedentary activity were measured via an accelerometer device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale</measure>
    <time_frame>Baseline, Month 4 (Follow-up)</time_frame>
    <description>The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) function subscale includes 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty), with ranges of 0-68 for the function subscale with higher scores indicating worse symptoms and function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale</measure>
    <time_frame>Baseline, Month 4 (Follow-up)</time_frame>
    <description>The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no pain) to 4 (extreme pain), with a total range of 0-20 with higher scores indicating worse symptoms and function.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Osteoarthritis Physical Activity Care Pathway</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 month physical activity (PA) counseling intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Osteoarthritis Physical Activity Care Pathway</intervention_name>
    <description>The intervention includes brief physical activity (PA) counseling delivered via phone by a PA Counselor trained in relevant aspects of PA and motivational interviewing. During the initial call, the PA counselor will assess readiness for change in PA and will utilize appropriate PA counseling components to assess participant's PA preferences/needs, as well as referral to PA resources and goal setting. Approximately two weeks after the initial call, the PA counselor will contact participants to check in on whether they have successfully connected with PA programs or resources discussed, review progress toward PA goals and set new goals. Participants will be provided with linkage to PA programs and resources to include: self-directed, group classes/community, physical therapy and other clinical/supervised programs. Three months after the initial call, the PA counselor will call participants to assess PA and stage of change using appropriate PA counseling components and goal setting.</description>
    <arm_group_label>Osteoarthritis Physical Activity Care Pathway</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physician diagnosis of knee or hip OA&#xD;
&#xD;
          -  Current Joint Symptoms&#xD;
&#xD;
          -  Current Weekly Physical Activity &lt;150 minutes per week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pain in chest when performing physical activity&#xD;
&#xD;
          -  Pain in chest when not performing physical activity&#xD;
&#xD;
          -  Loss of balance because of dizziness or loss of consciousness&#xD;
&#xD;
          -  Recommendation from doctor to only perform physical activity under medical supervision&#xD;
&#xD;
          -  No documented diagnosis of knee or hip OA&#xD;
&#xD;
          -  Dementia or other memory loss condition&#xD;
&#xD;
          -  Active diagnosis of psychosis&#xD;
&#xD;
          -  Active Substance abuse disorder&#xD;
&#xD;
          -  Total knee or hip replacement surgery, meniscus tear, ligament tear, or other&#xD;
             significant lower extremity injury or surgery in the last 6 months&#xD;
&#xD;
          -  Severe hearing or visual impairment&#xD;
&#xD;
          -  Serious/terminal illness as indicated by referral to hospice or palliative care&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Hospitalization for cardiovascular event in last 6 months&#xD;
&#xD;
          -  History of ventricular tachycardia&#xD;
&#xD;
          -  Unstable chronic obstructive pulmonary disease (2 hospitalizations within the previous&#xD;
             6 months and/or on oxygen)&#xD;
&#xD;
          -  Stroke with moderate to severe aphasia&#xD;
&#xD;
          -  Recent history (last 6 months) of three or more falls&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelli D Allen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Thurston Arthritis Research Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <results_first_submitted>August 10, 2020</results_first_submitted>
  <results_first_submitted_qc>August 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 25, 2020</results_first_posted>
  <last_update_submitted>August 10, 2020</last_update_submitted>
  <last_update_submitted_qc>August 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Knee Osteoarthritis</keyword>
  <keyword>Hip Osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <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>July 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03780400/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants with symptomatic, physician diagnosed knee or hip osteoarthritis (OA) were recruited from participating primary care providers in 3 University of North Carolina clinics between March 2019 and July 2019. The first participant was enrolled on March 21, 2019 and the last participant was enrolled on July 3, 2019.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>OA-PCP</title>
          <description>Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </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="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>OA-PCP</title>
          <description>Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="72.4" spread="5.6"/>
                  </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="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <description>Participants reporting at least some college.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <description>Participants reporting married or living with partner.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Work Status</title>
          <description>Participants reporting working full or part time.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.4" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Comorbid Illnesses</title>
          <description>Participants reported if they have or do not have these health conditions: heart disease, high blood pressure, lung disease, diabetes, ulcer/stomach diseases, kidney disease, liver disease, anemia or other blood diseases, cancer, depression, osteoarthritis/degenerative arthritis, back pain, rheumatoid arthritis or other health conditions (participant can report up to 3 other health conditions). Possible range 0 to 16.</description>
          <units>illnesses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.3" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years with Arthritis Symptoms</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.1" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Joints with Arthritis Symptoms</title>
          <units>joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.7" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week</title>
        <description>Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer</description>
        <time_frame>Baseline, Month 4 (Follow-up)</time_frame>
        <population>7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data</population>
        <group_list>
          <group group_id="O1">
            <title>OA-PCP</title>
            <description>Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week</title>
          <description>Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer</description>
          <population>7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.78" lower_limit="-1.6" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>test for within group change from baseline to 4 month follow-up</non_inferiority_desc>
            <p_value>0.5145</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 4 for Steps Per Day</title>
        <description>Step counts were measured via an accelerometer device.</description>
        <time_frame>Baseline, Month 4 (Follow-up)</time_frame>
        <population>7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data</population>
        <group_list>
          <group group_id="O1">
            <title>OA-PCP</title>
            <description>Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 4 for Steps Per Day</title>
          <description>Step counts were measured via an accelerometer device.</description>
          <population>7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data</population>
          <units>steps</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143.7" lower_limit="-174.9" upper_limit="462.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>test for within group change from baseline to 4 month follow-up</non_inferiority_desc>
            <p_value>0.3683</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 4 for Minutes of Sedentary Activity</title>
        <description>Minutes of sedentary activity were measured via an accelerometer device.</description>
        <time_frame>Baseline, Month 4 (Follow-up)</time_frame>
        <population>7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data</population>
        <group_list>
          <group group_id="O1">
            <title>OA-PCP</title>
            <description>Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 4 for Minutes of Sedentary Activity</title>
          <description>Minutes of sedentary activity were measured via an accelerometer device.</description>
          <population>7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" lower_limit="-17.0" upper_limit="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>test for within group change from baseline to 4 month follow-up</non_inferiority_desc>
            <p_value>0.9858</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale</title>
        <description>The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) function subscale includes 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty), with ranges of 0-68 for the function subscale with higher scores indicating worse symptoms and function.</description>
        <time_frame>Baseline, Month 4 (Follow-up)</time_frame>
        <population>7 participants did not complete month 4 follow-up assessment</population>
        <group_list>
          <group group_id="O1">
            <title>OA-PCP</title>
            <description>Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale</title>
          <description>The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) function subscale includes 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty), with ranges of 0-68 for the function subscale with higher scores indicating worse symptoms and function.</description>
          <population>7 participants did not complete month 4 follow-up assessment</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.1" lower_limit="-8.7" upper_limit="-3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>test for within group change from baseline to 4 month follow-up</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale</title>
        <description>The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no pain) to 4 (extreme pain), with a total range of 0-20 with higher scores indicating worse symptoms and function.</description>
        <time_frame>Baseline, Month 4 (Follow-up)</time_frame>
        <population>7 participants did not complete month 4 follow-up assessment</population>
        <group_list>
          <group group_id="O1">
            <title>OA-PCP</title>
            <description>Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale</title>
          <description>The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no pain) to 4 (extreme pain), with a total range of 0-20 with higher scores indicating worse symptoms and function.</description>
          <population>7 participants did not complete month 4 follow-up assessment</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" lower_limit="-2.7" upper_limit="-1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>test for within group change from baseline to 4 month follow-up</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data was collected starting at baseline to 4 months, ending at participants' final follow up time point.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>OA-PCP</title>
          <description>Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.</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="60"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="60"/>
              </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>Kelli D. Allen, PhD</name_or_title>
      <organization>University of North Carolina at Chapel Hill</organization>
      <phone>919-966-0558</phone>
      <email>kdallen@email.unc.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/NCT03780400
org study id: 18-0877
secondary id: 1R21AG056568
nct id: NCT03780400
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multi-phase study that will develop and test an osteoarthritis (OA) primary care
      Physical activity Care Pathway (OA-PCP), a scalable intervention that includes: 1) a
      practical process for physical inactivity screening in primary care, 2) a brief, tailored
      physical activity (PA) counseling intervention via telephone, 3) connection of patients with
      community programs and other resources to support PA, and 4) follow-up with patients to
      deliver additional appropriate counseling and referrals to PA resources.
This study will be a single group pilot trial of the OA-PCP. The feasibility and
      acceptability of the OA-PCP will be assessed among n=60 patients with hip and knee OA in two
      primary care clinics. All patients in the trial will participate in the OA-PCP and will
      complete assessments at baseline and 4-month follow-up. Feasibility metrics will include
      rates of recruitment, intervention engagement and retention; acceptability will be assessed
      from both patients and health care providers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week
time frame: Baseline, Month 4 (Follow-up)
description: Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer
measure: Change From Baseline to Month 4 for Steps Per Day
time frame: Baseline, Month 4 (Follow-up)
description: Step counts were measured via an accelerometer device.
measure: Change From Baseline to Month 4 for Minutes of Sedentary Activity
time frame: Baseline, Month 4 (Follow-up)
description: Minutes of sedentary activity were measured via an accelerometer device.
measure: Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
time frame: Baseline, Month 4 (Follow-up)
description: The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) function subscale includes 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty), with ranges of 0-68 for the function subscale with higher scores indicating worse symptoms and function.
measure: Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
time frame: Baseline, Month 4 (Follow-up)
description: The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no pain) to 4 (extreme pain), with a total range of 0-20 with higher scores indicating worse symptoms and function.
arm group label: Osteoarthritis Physical Activity Care Pathway
arm group type: Experimental
description: 4 month physical activity (PA) counseling intervention
intervention type: Behavioral
intervention name: Osteoarthritis Physical Activity Care Pathway
description: The intervention includes brief physical activity (PA) counseling delivered via phone by a PA Counselor trained in relevant aspects of PA and motivational interviewing. During the initial call, the PA counselor will assess readiness for change in PA and will utilize appropriate PA counseling components to assess participant's PA preferences/needs, as well as referral to PA resources and goal setting. Approximately two weeks after the initial call, the PA counselor will contact participants to check in on whether they have successfully connected with PA programs or resources discussed, review progress toward PA goals and set new goals. Participants will be provided with linkage to PA programs and resources to include: self-directed, group classes/community, physical therapy and other clinical/supervised programs. Three months after the initial call, the PA counselor will call participants to assess PA and stage of change using appropriate PA counseling components and goal setting.
arm group label: Osteoarthritis Physical Activity Care Pathway
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Kelli D Allen, PhD
role: Principal Investigator
affiliation: UNC Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 