<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/NCT03245463</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0731</org_study_id>
    <nct_id>NCT03245463</nct_id>
  </id_info>
  <brief_title>Evaluation of Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis</brief_title>
  <official_title>Evaluation of Different Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Symptomatic knee osteoarthritis greatly impacts the quality of life, mobility, independence,&#xD;
      and even safety of the individuals who suffer from it. One of the most powerful tools for&#xD;
      these patients can be education on self-care and self-management strategies that can be&#xD;
      taught to a patient by a physician, physical or occupational therapist, or a nurse. These&#xD;
      self-management strategies can help patients treat daily stiffness through exercise or manage&#xD;
      flares of osteoarthritis. There is a lack of consensus on the best teaching methods to&#xD;
      accomplish the goal of educating our patients. Feedback from both patients and providers&#xD;
      regarding teaching methods is needed. This study will evaluate teaching methods on&#xD;
      self-management strategies for patients who are undergoing hyaluronic acid injections for&#xD;
      knee osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 9, 2017</start_date>
  <completion_date type="Actual">February 13, 2018</completion_date>
  <primary_completion_date type="Actual">February 13, 2018</primary_completion_date>
  <phase>Phase 4</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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Satisfaction With the Teaching Method</measure>
    <time_frame>1 month post-injection</time_frame>
    <description>Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Provider Satisfaction With the Teaching Method</measure>
    <time_frame>1 month post-injection</time_frame>
    <description>Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Satisfaction With the Teaching Method</measure>
    <time_frame>3 months post-injection</time_frame>
    <description>Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Who Would Have Preferred a Different Method of Receiving Education.</measure>
    <time_frame>3 months post-injection</time_frame>
    <description>Patient will be asked: &quot;Would you have preferred a different method of receiving education?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis</measure>
    <time_frame>3 months post-injection</time_frame>
    <description>Patient will be asked: &quot;Did the education you received help with the care of your osteoarthritis?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Physical Health Score</measure>
    <time_frame>3 months post-injection</time_frame>
    <description>The physical health score will be surveyed using the PROMIS-10 global health questionnaire. A higher score indicates better physical health. Scores range from 16.2 to 67.7.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Teaching Method A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Teaching Method B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational handout</intervention_name>
    <description>The educational handout will include information on self-management strategies.</description>
    <arm_group_label>Teaching Method A</arm_group_label>
    <arm_group_label>Teaching Method B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Verbal script</intervention_name>
    <description>The verbal script will include details on self-management strategies that will be reviewed with the patient.</description>
    <arm_group_label>Teaching Method B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyaluronic Acid</intervention_name>
    <description>All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
    <arm_group_label>Teaching Method A</arm_group_label>
    <arm_group_label>Teaching Method B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of co-investigator physicians&#xD;
&#xD;
          -  Age 18+ years&#xD;
&#xD;
          -  Diagnosis of symptomatic knee osteoarthritis&#xD;
&#xD;
          -  Scheduled for a hyaluronic acid injection into the knee&#xD;
&#xD;
          -  Provider is available to administer teaching method&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are already enrolled in the study&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Wyss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <results_first_submitted>August 9, 2019</results_first_submitted>
  <results_first_submitted_qc>October 16, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 5, 2019</results_first_posted>
  <last_update_submitted>October 16, 2019</last_update_submitted>
  <last_update_submitted_qc>October 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <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>July 25, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03245463/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Teaching Method A</title>
          <description>Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
        </group>
        <group group_id="P2">
          <title>Teaching Method B</title>
          <description>Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Teaching Method A</title>
          <description>Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
        </group>
        <group group_id="B2">
          <title>Teaching Method B</title>
          <description>Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</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="12"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="24"/>
          </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="71" spread="8"/>
                    <measurement group_id="B2" value="69" spread="13"/>
                    <measurement group_id="B3" value="70" spread="10"/>
                  </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="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="20"/>
                  </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="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </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="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Average pain</title>
          <description>Average pain was assessed using a 0-10 scale, where 0 represents no pain and 10 represents worst possible pain. Higher scores represent worse outcomes.</description>
          <units>units on a 0-10 scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.6" spread="2.2"/>
                    <measurement group_id="B2" value="4.8" spread="2.3"/>
                    <measurement group_id="B3" value="5.2" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Satisfaction With the Teaching Method</title>
        <description>Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.</description>
        <time_frame>1 month post-injection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Teaching Method A</title>
            <description>Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
          </group>
          <group group_id="O2">
            <title>Teaching Method B</title>
            <description>Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With the Teaching Method</title>
          <description>Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.</description>
          <units>units 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="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" spread="1.6"/>
                    <measurement group_id="O2" value="8.3" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Provider Satisfaction With the Teaching Method</title>
        <description>Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.</description>
        <time_frame>1 month post-injection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Teaching Method A</title>
            <description>Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
          </group>
          <group group_id="O2">
            <title>Teaching Method B</title>
            <description>Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Provider Satisfaction With the Teaching Method</title>
          <description>Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.</description>
          <units>units 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="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="1.9"/>
                    <measurement group_id="O2" value="8.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Satisfaction With the Teaching Method</title>
        <description>Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.</description>
        <time_frame>3 months post-injection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Teaching Method A</title>
            <description>Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
          </group>
          <group group_id="O2">
            <title>Teaching Method B</title>
            <description>Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With the Teaching Method</title>
          <description>Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.</description>
          <units>units 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="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="2.2"/>
                    <measurement group_id="O2" value="8.6" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Who Would Have Preferred a Different Method of Receiving Education.</title>
        <description>Patient will be asked: &quot;Would you have preferred a different method of receiving education?&quot;</description>
        <time_frame>3 months post-injection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Teaching Method A</title>
            <description>Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
          </group>
          <group group_id="O2">
            <title>Teaching Method B</title>
            <description>Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Who Would Have Preferred a Different Method of Receiving Education.</title>
          <description>Patient will be asked: &quot;Would you have preferred a different method of receiving education?&quot;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis</title>
        <description>Patient will be asked: &quot;Did the education you received help with the care of your osteoarthritis?&quot;</description>
        <time_frame>3 months post-injection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Teaching Method A</title>
            <description>Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
          </group>
          <group group_id="O2">
            <title>Teaching Method B</title>
            <description>Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis</title>
          <description>Patient will be asked: &quot;Did the education you received help with the care of your osteoarthritis?&quot;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PROMIS Physical Health Score</title>
        <description>The physical health score will be surveyed using the PROMIS-10 global health questionnaire. A higher score indicates better physical health. Scores range from 16.2 to 67.7.</description>
        <time_frame>3 months post-injection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Teaching Method A</title>
            <description>Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
          </group>
          <group group_id="O2">
            <title>Teaching Method B</title>
            <description>Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS Physical Health Score</title>
          <description>The physical health score will be surveyed using the PROMIS-10 global health questionnaire. A higher score indicates better physical health. Scores range from 16.2 to 67.7.</description>
          <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="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.8" spread="5.1"/>
                    <measurement group_id="O2" value="48.4" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected over 3 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Teaching Method A</title>
          <description>Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</description>
        </group>
        <group group_id="E2">
          <title>Teaching Method B</title>
          <description>Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).&#xD;
Educational handout: The educational handout will include information on self-management strategies.&#xD;
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.&#xD;
Hyaluronic Acid: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.</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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </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>Dr. James Wyss</name_or_title>
      <organization>Hospital for Special Surgery</organization>
      <phone>2126061731</phone>
      <email>wyssj@hss.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/NCT03245463
org study id: 2017-0731
nct id: NCT03245463
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Symptomatic knee osteoarthritis greatly impacts the quality of life, mobility, independence,
      and even safety of the individuals who suffer from it. One of the most powerful tools for
      these patients can be education on self-care and self-management strategies that can be
      taught to a patient by a physician, physical or occupational therapist, or a nurse. These
      self-management strategies can help patients treat daily stiffness through exercise or manage
      flares of osteoarthritis. There is a lack of consensus on the best teaching methods to
      accomplish the goal of educating our patients. Feedback from both patients and providers
      regarding teaching methods is needed. This study will evaluate teaching methods on
      self-management strategies for patients who are undergoing hyaluronic acid injections for
      knee osteoarthritis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Patient Satisfaction With the Teaching Method
time frame: 1 month post-injection
description: Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.
measure: Provider Satisfaction With the Teaching Method
time frame: 1 month post-injection
description: Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.
measure: Patient Satisfaction With the Teaching Method
time frame: 3 months post-injection
description: Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.
measure: Number of Patients Who Would Have Preferred a Different Method of Receiving Education.
time frame: 3 months post-injection
description: Patient will be asked: "Would you have preferred a different method of receiving education?"
measure: Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis
time frame: 3 months post-injection
description: Patient will be asked: "Did the education you received help with the care of your osteoarthritis?"
measure: PROMIS Physical Health Score
time frame: 3 months post-injection
description: The physical health score will be surveyed using the PROMIS-10 global health questionnaire. A higher score indicates better physical health. Scores range from 16.2 to 67.7.
arm group label: Teaching Method A
arm group type: Active Comparator
description: Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.
arm group label: Teaching Method B
arm group type: Active Comparator
description: Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).
intervention type: Other
intervention name: Educational handout
description: The educational handout will include information on self-management strategies.
arm group label: Teaching Method A
arm group label: Teaching Method B
intervention type: Other
intervention name: Verbal script
description: The verbal script will include details on self-management strategies that will be reviewed with the patient.
arm group label: Teaching Method B
intervention type: Drug
intervention name: Hyaluronic Acid
description: All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.
arm group label: Teaching Method A
arm group label: Teaching Method B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James Wyss, MD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Hyaluronic Acid
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 