<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/NCT03036215</url>
  </required_header>
  <id_info>
    <org_study_id>5U01DE025609-02</org_study_id>
    <nct_id>NCT03036215</nct_id>
  </id_info>
  <brief_title>Tailored Self-Management of Temporomandibular Disorders (TMD) Using Health Information Technology</brief_title>
  <acronym>TMDPACT</acronym>
  <official_title>Tailored Self-Management of TMD Pain Using Health Information Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HealthPartners Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HealthPartners Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot project is to determine the feasibility and acceptability of&#xD;
      proposed methods for a subsequent clinical trial of a tailored self-management program (PACT)&#xD;
      designed to decrease pain in participants with temporomandibular disorders (TMD). The PACT&#xD;
      program is a personalized program of exercise and behavioral changes implemented through a&#xD;
      web-based program supported by a health coach. For this feasibility and acceptability study,&#xD;
      80 adults with TMD pain will be randomized either to the PACT program or to traditional&#xD;
      self-care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary study objectives of the PACT study are two-fold:&#xD;
&#xD;
        1. Evaluate the feasibility of methods to conduct a full-scale multi-site randomized&#xD;
           clinical trial comparing PACT self-management with traditional self-care for TMD. The&#xD;
           study will also evaluate strategies to: identify, recruit, consent, and enroll eligible&#xD;
           subjects into both groups meeting target goal; evaluate adherence to intervention and&#xD;
           identification of barriers; evaluate adherence to outcomes assessment, and evaluate the&#xD;
           on-line web-site functionality and acceptability.&#xD;
&#xD;
        2. To demonstrate ability to accurately capture outcome measures to be used in the&#xD;
           multi-site study.&#xD;
&#xD;
      Primary study objective: Recruitment is measured through achievement of target sample, number&#xD;
      of patients identified that meet eligibility criteria, and number (%) of subjects consenting&#xD;
      compared with total contacted.&#xD;
&#xD;
      Intervention adherence is measured by: number of participants enrolled in both groups, number&#xD;
      of participants accessing on-line materials, completion of practice logs, and identification&#xD;
      of self-reported barriers of participation in self-care. Outcome adherence is measured by the&#xD;
      number of participants who complete the baseline assessment, complete the two and four month&#xD;
      follow-up assessments, complete the program evaluation, and complete qualitative post-study&#xD;
      interview. Website acceptability is measure by identification of problems and barriers during&#xD;
      use and quality and ease of use at the post-intervention evaluation.&#xD;
&#xD;
      Second objective: Efficacy of the program is measured by self-reported outcome assessments.&#xD;
      The primary outcomes include TMD symptoms, jaw functioning, and emotional functioning.&#xD;
      Secondary outcomes measures include symptom severity with the temporal aspects of pain, pain&#xD;
      interference, and patient ratings of improvement. Additional information on mediators and&#xD;
      modifiers will also be gathered to help inform the how and why the intervention has an&#xD;
      effect. Mediators will be measured to identify factors that help explain why PACT may have an&#xD;
      effect including self-efficacy, patient activation, exercise level, sleep quality, and social&#xD;
      support. Contextual process factors to identify in whom the intervention does and does not&#xD;
      work include disability status, catastrophizing, depression, repetitive strain from oral&#xD;
      habits, and perceived stress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 8, 2017</start_date>
  <completion_date type="Actual">November 9, 2017</completion_date>
  <primary_completion_date type="Actual">November 9, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The pilot study design is a 2-arm randomized clinical trial to test the methods that will be used in a future proposal for a full-scale multi-site clinical trial. The two aims include: 1) evaluate the feasibility of methods to conduct a full-scale multi-site randomized clinical trial comparing the PACT self-management with usual self-care for TMD and, 2) estimate the parameters needed to plan for a larger multi-site trial including the effect size and standard deviation for primary outcomes of pain and function. A traditional self-care control arm is added to determine the acceptability of randomization and the feasibility of collecting baseline and follow-up data from a traditional care control arm for the full-scale study.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program</measure>
    <time_frame>Change from baseline to 16 weeks post intervention</time_frame>
    <description>Measure: Graded Chronic Pain Scale (GCPS) with mean intensity ratings for reported current, worst, and average pain. 3 items: Scale 0-100 (100 most severe)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessing Change in Jaw Functioning</measure>
    <time_frame>Change from baseline to 16 weeks post intervention</time_frame>
    <description>Jaw Functional Limitation Scale (JFLS-8) identifies daily activities interfered with by jaw pain - 8 items Scale 0-80 (80 more severe)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Graded Chronic Pain Interference</measure>
    <time_frame>Change from baseline to 16 weeks post intervention</time_frame>
    <description>Assessment of graded Chronic Pain Interference - Scale (0-100); 0 = lowest pain interference 100 = highest pain interference. If findings in negative values = improvement; positive values = worsening condition.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Temporomandibular Joint Dysfunction Syndrome</condition>
  <arm_group>
    <arm_group_label>Traditional Self-Care Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Traditional self-care includes focusing on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants will also participate in usual care from the dentist such as a splint or anti-inflammatory medications. Participants will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PACT Experimental Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If selected for the PACT care arm, participant will be prompted to complete a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. Participant will also participate in usual care from the dentist such as a splint or anti- inflammatory medications.Participant will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PACT Experimental Arm</intervention_name>
    <description>The study will employ a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors that have evidence of improving TMD pain.</description>
    <arm_group_label>PACT Experimental Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In order to be eligible to participate in this study, an individual must meet all of&#xD;
             the following criteria:&#xD;
&#xD;
               -  Age 18 or older&#xD;
&#xD;
               -  Able and willing to access the internet on a regular basis&#xD;
&#xD;
               -  Able to read and speak English&#xD;
&#xD;
               -  Be willing to comply with all study procedures:&#xD;
&#xD;
                    1. Randomly assigned to either arm of the study&#xD;
&#xD;
                    2. Be available for the duration of the study&#xD;
&#xD;
                    3. Complete study data collection forms&#xD;
&#xD;
                    4. Reachable by phone and able to participate in weekly phone coaching calls if&#xD;
                       randomized to the PACT arm&#xD;
&#xD;
               -  Have a diagnosis of TMD pain using a self-report screener. These questions&#xD;
                  include;&#xD;
&#xD;
                    1. In the last 30 days, which of the following best describes any pain in your&#xD;
                       jaw or temple area on either side?&#xD;
&#xD;
                    2. In the last 30 days, have you had pain or stiffness in your jaw on&#xD;
                       awakening?&#xD;
&#xD;
                    3. In the last 30 days, did the following activities change any pain (that is,&#xD;
                       make it better or make it worse) in your jaw or temple area on either side?&#xD;
                       Chewing hard or tough food, Opening your mouth or moving your jaw forward or&#xD;
                       to the side, Jaw habits such as holding teeth together, clenching/grinding,&#xD;
                       or chewing gum, or other jaw activities such as talking, kissing, or yawning&#xD;
&#xD;
               -  Frequency of TMD pain more than once a week with pain in the past 6 months&#xD;
&#xD;
               -  Electronically sign an informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An individual who meets any of the following criteria will be excluded from&#xD;
             participation in this study:&#xD;
&#xD;
               -  Currently participating in any other TMD and temporomandibular joint (TMJ)&#xD;
                  related studies&#xD;
&#xD;
               -  Major disk disorder that requires opioids or surgery for TMD pain&#xD;
&#xD;
               -  Serious medical condition that might interfere with or prohibit participation in&#xD;
                  an online program or pregnancy&#xD;
&#xD;
               -  Treatment for a mental health disorder or substance abuse in the past six months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James R. Fricton, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>HealthPartners Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robin R. Whitebird, PhD, MSW</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of St Thomas , School of Social Work</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HealthPartners Clinic</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <results_first_submitted>February 20, 2018</results_first_submitted>
  <results_first_submitted_qc>May 16, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 15, 2018</results_first_posted>
  <last_update_submitted>May 16, 2018</last_update_submitted>
  <last_update_submitted_qc>May 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2018</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>Joint Diseases</mesh_term>
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03036215/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03036215/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03036215/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Traditional Self-Care Control Arm</title>
          <description>Traditional self-care focuses on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants in the traditional arm may also be receiving usual care from their dentist such as a splint or anti-inflammatory medications. They will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end).</description>
        </group>
        <group group_id="P2">
          <title>PACT Experimental Arm</title>
          <description>Participants enrolled in the experimental arm are prompted to complete a self-management program, Personalized Activated Care and Training (PACT), The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors designed to improve TMD pain. Participants also complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). These participants are also supported by a health coach.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Traditional Self-Care Control Arm</title>
          <description>Traditional self-care includes focusing on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants will also participate in usual care from the dentist such as a splint or anti-inflammatory medications. Participants will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). .</description>
        </group>
        <group group_id="B2">
          <title>PACT Experimental Arm</title>
          <description>PACT Experimental Arm: The study employs a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors that have evidence of improving TMD pain.</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="41"/>
            <count group_id="B2" value="39"/>
            <count group_id="B3" value="80"/>
          </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="49" spread="15.1"/>
                    <measurement group_id="B2" value="46" spread="17.1"/>
                    <measurement group_id="B3" value="47.5" spread="16.1"/>
                  </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="35"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" 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 group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="70"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <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="41"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Graded Chronic Pain Severity</title>
          <description>Pain Intensity is a O-100 score derived from questions 1-3:&#xD;
Mean (Pain Right Now, Worst Pain, Average Pain) x 10; Item Scale is from 0=No pain to 10=Pain as bad as it could be</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50" spread="15"/>
                    <measurement group_id="B2" value="50" spread="17.6"/>
                    <measurement group_id="B3" value="50" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Graded Chronic Pain interference</title>
          <description>Graded Chronic Pain Interference subscale:&#xD;
Interference Score is a O-100 score derived from 3 questions:&#xD;
Mean (Daily Activities, Social Activities, Work Activities) x 10; Scale 0=no interference up to 10=unable to carry on activities</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.6" spread="23.7"/>
                    <measurement group_id="B2" value="23" spread="21.3"/>
                    <measurement group_id="B3" value="24.9" spread="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Jaw Functioning</title>
          <description>Level of limitation during the last 30 days. Scale 0-10 of drink, Soft food, Swallow, Talk, Smile, Chew, Yawn, Hard food. JAW FUNCTIONING 8 items R:0-80; Item scale: 0 = No limitation up to 10=Severe limitation</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.5" spread="18.9"/>
                    <measurement group_id="B2" value="19.4" spread="14"/>
                    <measurement group_id="B3" value="22" spread="16.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program</title>
        <description>Measure: Graded Chronic Pain Scale (GCPS) with mean intensity ratings for reported current, worst, and average pain. 3 items: Scale 0-100 (100 most severe)</description>
        <time_frame>Change from baseline to 16 weeks post intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Traditional Self-Care Control Arm</title>
            <description>Traditional self-care focuses on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants in the traditional arm may also be receiving usual care from their dentist such as a splint or anti-inflammatory medications. They will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end).</description>
          </group>
          <group group_id="O2">
            <title>PACT Experimental Arm</title>
            <description>Participants enrolled in the experimental arm are prompted to complete a self-management program, Personalized Activated Care and Training (PACT), The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors designed to improve TMD pain. Participants also complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). These participants are also supported by a health coach.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program</title>
          <description>Measure: Graded Chronic Pain Scale (GCPS) with mean intensity ratings for reported current, worst, and average pain. 3 items: Scale 0-100 (100 most severe)</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="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12" spread="16.8"/>
                    <measurement group_id="O2" value="-19" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Pilot study, no power analysis applicable; no statistical test</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-7</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessing Change in Jaw Functioning</title>
        <description>Jaw Functional Limitation Scale (JFLS-8) identifies daily activities interfered with by jaw pain - 8 items Scale 0-80 (80 more severe)</description>
        <time_frame>Change from baseline to 16 weeks post intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Traditional Self-Care Control Arm</title>
            <description>Traditional self-care includes focusing on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants will also participate in usual care from the dentist such as a splint or anti-inflammatory medications. Participants will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). .</description>
          </group>
          <group group_id="O2">
            <title>PACT Experimental Arm</title>
            <description>The study will employ a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors that have evidence of improving TMD pain.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessing Change in Jaw Functioning</title>
          <description>Jaw Functional Limitation Scale (JFLS-8) identifies daily activities interfered with by jaw pain - 8 items Scale 0-80 (80 more severe)</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="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.9" spread="14.9"/>
                    <measurement group_id="O2" value="-6.9" spread="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Pilot study; no statistical test run</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>pilot study; no statistical test performed</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Graded Chronic Pain Interference</title>
        <description>Assessment of graded Chronic Pain Interference - Scale (0-100); 0 = lowest pain interference 100 = highest pain interference. If findings in negative values = improvement; positive values = worsening condition.</description>
        <time_frame>Change from baseline to 16 weeks post intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Traditional Self-Care Control Arm</title>
            <description>Traditional self-care includes focusing on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants will also participate in usual care from the dentist such as a splint or anti-inflammatory medications. Participants will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). .</description>
          </group>
          <group group_id="O2">
            <title>PACT Experimental Arm</title>
            <description>PACT Experimental Arm: The study employs a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors that have evidence of improving TMD pain.</description>
          </group>
        </group_list>
        <measure>
          <title>Graded Chronic Pain Interference</title>
          <description>Assessment of graded Chronic Pain Interference - Scale (0-100); 0 = lowest pain interference 100 = highest pain interference. If findings in negative values = improvement; positive values = worsening condition.</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="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.8" spread="20.7"/>
                    <measurement group_id="O2" value="-11" spread="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Pilot study; no statistical test for significance run</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-5.2</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>through study completion; an average of 16 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Traditional Self-Care Control Arm</title>
          <description>Traditional self-care includes focusing on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants will also participate in usual care from the dentist such as a splint or anti-inflammatory medications. Participants will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). .</description>
        </group>
        <group group_id="E2">
          <title>PACT Experimental Arm</title>
          <description>PACT intervention employs a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors that have evidence of improving TMD pain.</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="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </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="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>James Fricton, DDS, Senior Research Investigator</name_or_title>
      <organization>HealthPartners Institute</organization>
      <phone>6126191678</phone>
      <email>james.r.fricton@healthpartners.com</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/NCT03036215
org study id: 5U01DE025609-02
nct id: NCT03036215
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this pilot project is to determine the feasibility and acceptability of
      proposed methods for a subsequent clinical trial of a tailored self-management program (PACT)
      designed to decrease pain in participants with temporomandibular disorders (TMD). The PACT
      program is a personalized program of exercise and behavioral changes implemented through a
      web-based program supported by a health coach. For this feasibility and acceptability study,
      80 adults with TMD pain will be randomized either to the PACT program or to traditional
      self-care.
The primary study objectives of the PACT study are two-fold:

        1. Evaluate the feasibility of methods to conduct a full-scale multi-site randomized
           clinical trial comparing PACT self-management with traditional self-care for TMD. The
           study will also evaluate strategies to: identify, recruit, consent, and enroll eligible
           subjects into both groups meeting target goal; evaluate adherence to intervention and
           identification of barriers; evaluate adherence to outcomes assessment, and evaluate the
           on-line web-site functionality and acceptability.

        2. To demonstrate ability to accurately capture outcome measures to be used in the
           multi-site study.

      Primary study objective: Recruitment is measured through achievement of target sample, number
      of patients identified that meet eligibility criteria, and number (%) of subjects consenting
      compared with total contacted.

      Intervention adherence is measured by: number of participants enrolled in both groups, number
      of participants accessing on-line materials, completion of practice logs, and identification
      of self-reported barriers of participation in self-care. Outcome adherence is measured by the
      number of participants who complete the baseline assessment, complete the two and four month
      follow-up assessments, complete the program evaluation, and complete qualitative post-study
      interview. Website acceptability is measure by identification of problems and barriers during
      use and quality and ease of use at the post-intervention evaluation.

      Second objective: Efficacy of the program is measured by self-reported outcome assessments.
      The primary outcomes include TMD symptoms, jaw functioning, and emotional functioning.
      Secondary outcomes measures include symptom severity with the temporal aspects of pain, pain
      interference, and patient ratings of improvement. Additional information on mediators and
      modifiers will also be gathered to help inform the how and why the intervention has an
      effect. Mediators will be measured to identify factors that help explain why PACT may have an
      effect including self-efficacy, patient activation, exercise level, sleep quality, and social
      support. Contextual process factors to identify in whom the intervention does and does not
      work include disability status, catastrophizing, depression, repetitive strain from oral
      habits, and perceived stress.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The pilot study design is a 2-arm randomized clinical trial to test the methods that will be used in a future proposal for a full-scale multi-site clinical trial. The two aims include: 1) evaluate the feasibility of methods to conduct a full-scale multi-site randomized clinical trial comparing the PACT self-management with usual self-care for TMD and, 2) estimate the parameters needed to plan for a larger multi-site trial including the effect size and standard deviation for primary outcomes of pain and function. A traditional self-care control arm is added to determine the acceptability of randomization and the feasibility of collecting baseline and follow-up data from a traditional care control arm for the full-scale study.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program
time frame: Change from baseline to 16 weeks post intervention
description: Measure: Graded Chronic Pain Scale (GCPS) with mean intensity ratings for reported current, worst, and average pain. 3 items: Scale 0-100 (100 most severe)
measure: Assessing Change in Jaw Functioning
time frame: Change from baseline to 16 weeks post intervention
description: Jaw Functional Limitation Scale (JFLS-8) identifies daily activities interfered with by jaw pain - 8 items Scale 0-80 (80 more severe)
measure: Graded Chronic Pain Interference
time frame: Change from baseline to 16 weeks post intervention
description: Assessment of graded Chronic Pain Interference - Scale (0-100); 0 = lowest pain interference 100 = highest pain interference. If findings in negative values = improvement; positive values = worsening condition.
arm group label: Traditional Self-Care Control Arm
arm group type: No Intervention
description: Traditional self-care includes focusing on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants will also participate in usual care from the dentist such as a splint or anti-inflammatory medications. Participants will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). .
arm group label: PACT Experimental Arm
arm group type: Experimental
description: If selected for the PACT care arm, participant will be prompted to complete a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. Participant will also participate in usual care from the dentist such as a splint or anti- inflammatory medications.Participant will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end).
intervention type: Behavioral
intervention name: PACT Experimental Arm
description: The study will employ a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors that have evidence of improving TMD pain.
arm group label: PACT Experimental Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James R. Fricton, DDS
role: Principal Investigator
affiliation: HealthPartners Institute
last name: Robin R. Whitebird, PhD, MSW
role: Principal Investigator
affiliation: University of St Thomas , School of Social Work
facility: 
country: United States
responsible party type: Sponsor
mesh term: Joint Diseases
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 