<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/NCT03301714</url>
  </required_header>
  <id_info>
    <org_study_id>TempleU</org_study_id>
    <nct_id>NCT03301714</nct_id>
  </id_info>
  <brief_title>Oral Health Education Interventions Among Seniors</brief_title>
  <official_title>Oral Health Education Interventions and Its Association With Behavioral Outcomes: A Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Colgate Palmolive</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>KleinLife</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Temple University</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 study aims to assess the efficacy of an oral health education group based activity versus&#xD;
      an individual based oral health education activity in terms of changes in oral health related&#xD;
      quality of life (OHRQoL), self-efficacy and oral health knowledge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Older adults have been described as one of the most underserved and vulnerable groups, who&#xD;
      are at the highest risk for coronal and root caries, especially because more elderly adults&#xD;
      are retaining their teeth. The Northeast Philadelphia KleinLife site is an important&#xD;
      destination for the region's Jewish population comprising of at least 6500 seniors, and&#xD;
      assisting more than 4500 seniors through food security programs. Recently, Temple University&#xD;
      Kornberg School of Dentistry (TUKSoD) purchased the dental center at the facility to expand&#xD;
      the services provided to these underserved population and improve their oral health. The&#xD;
      study aims to assess the efficacy of an oral health education group based activity versus an&#xD;
      individual based oral health education activity in terms of changes in oral health related&#xD;
      quality of life (OHRQoL), self-efficacy and oral health knowledge. Methods: A non-probability&#xD;
      sample of 190 senior members will be invited to participate in the trial. Potential subjects&#xD;
      will be obtained in person through the ongoing flow of patients at TUKSoD Clinic at Kleinlife&#xD;
      and the dental school. Seniors who consent to participate in the study will be randomly&#xD;
      allocated to one of the 3 groups (Control: subjects will continue receiving regular dental&#xD;
      care at the clinic, Intervention 1: subjects will continue receiving regular dental care at&#xD;
      the clinic and be invited to participate in 2 group based education sessions during a 12&#xD;
      month period, and Intervention 2: subjects will continue receiving regular dental care at the&#xD;
      clinic and be invited to participate in an individual-based education and prevention activity&#xD;
      over a 18 month period. Randomization will be determined according to a predetermined random&#xD;
      sequence, and neither the patient nor the research staff will be aware of the randomization&#xD;
      outcome until after the patient has agreed to participate. The OHIP-14 will be used to assess&#xD;
      OHRQoL, and self-efficacy scores will be the primary outcomes. Initially, we will assess the&#xD;
      differences between the interventions and control using 2-sample t-tests. The main analysis&#xD;
      will be based on linear mixed-effects models for repeated measures (using the OHIP 14 and&#xD;
      self-efficacy scores as continuous outcome variables) to assess differences between&#xD;
      intervention and control groups. Similar analyses will be conducted for secondary outcome&#xD;
      measures Statistical significance will be set at p &lt; .05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Oral Health Related Quality of Life (OHIP-14; Slade, 1997)</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>The oral health related quality of life scale is a 14-item measurement of individuals' perceptions of the social impact of oral conditions on their well-being. This scale evaluates the consequences of oral conditions across dimensions of functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Items are rated on a 5- point Likert type scale ranging from 0 (never) to 4 (very often), regarding how frequently impact has been experienced. The total score ranges from 0 to 56; higher OHIP-14 scores indicate greater impact, hence poorer oral-health-related quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Oral Health Self Efficacy (Modified Version of Finlayson, 2007).</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>Oral health self efficacy uses a 6 item scale and is a measurement of how confident seniors feel about their ability to perform oral hygiene tasks (1) under a lot of stress; (2) being depressed; (3) feeling anxious; (4) feeling that they were too busy; (5) being tired or; (6) being worried about other things in their life. The four response options range from 'very confident' to 'not at all confident'. The possible score range is 0 to 24,with high scores indicating high self-efficacy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Oral Health Knowledge (Khanagar, 2014)</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>Oral health knowledge measurement of the seniors pre and post intervention will be conducted using a list of 15 knowledge statements to which subjects had to report agreement wit the statement (yes), disagreement (no) or don't know. The frequency numbers provided in the results table correspond to correct responses for each individual item.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Quality of Life</condition>
  <condition>Self Efficacy</condition>
  <condition>Knowledge</condition>
  <arm_group>
    <arm_group_label>Control: Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Regular dental care under the standard clinic operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention 1: Group-based oral health education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group based oral health education</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention 2: Individual-based oral health education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individual-based motivational interviewing</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Oral Health Education</intervention_name>
    <description>Group-based oral health education vs Individual-based oral health education using motivational interviewing</description>
    <arm_group_label>Intervention 1: Group-based oral health education</arm_group_label>
    <arm_group_label>Intervention 2: Individual-based oral health education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must be 55 years old or older.&#xD;
&#xD;
          2. May be new, regular, emergency patients attending the TUKSoD clinic at Kleinlife or&#xD;
             clinics at the Dental School or utilizing medical and social services at Kleinlife who&#xD;
             have the intention to become patients of record at the dental clinic.&#xD;
&#xD;
          3. Must be able to speak and understand English.&#xD;
&#xD;
          4. Must be willing to provide consent to participate in the study for himself/herself.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects younger than 55 years old will be excluded from the study.&#xD;
&#xD;
          2. Subjects who do not provide consent for participation will be excluded from the study.&#xD;
&#xD;
          3. Subjects who do not speak and understand English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MARISOL TELLEZ, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor Temple University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Temple Univerity Kornberg School of Dentistry</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <results_first_submitted>March 2, 2020</results_first_submitted>
  <results_first_submitted_qc>May 4, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 12, 2020</results_first_posted>
  <last_update_submitted>May 4, 2020</last_update_submitted>
  <last_update_submitted_qc>May 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>motivational interviewing</keyword>
  <keyword>elderly</keyword>
  <keyword>oral health</keyword>
  <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>August 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03301714/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control: Standard of Care</title>
          <description>Regular dental care under the standard clinic operation</description>
        </group>
        <group group_id="P2">
          <title>Intervention 1: Group-based Oral Health Education</title>
          <description>Group based oral health education&#xD;
Oral Health Education: Group based oral health education vs Individual motivational interviewing</description>
        </group>
        <group group_id="P3">
          <title>Intervention 2:Individual-based Oral Health Education Using MI</title>
          <description>Individual-based motivational interviewing&#xD;
Oral Health Education: Group based oral health education vs Individual motivational interviewing</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="54"/>
                <participants group_id="P3" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not receive allocated intervention</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>Regular dental care under the standard clinic operation</description>
        </group>
        <group group_id="B2">
          <title>Intervention 1</title>
          <description>Group based oral health education&#xD;
Oral Health Education: Group based oral health education vs Individual motivational interviewing</description>
        </group>
        <group group_id="B3">
          <title>Intervention 2</title>
          <description>Individual-based motivational interviewing&#xD;
Oral Health Education: Group based oral health education vs Individual motivational interviewing</description>
        </group>
        <group group_id="B4">
          <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="60"/>
            <count group_id="B2" value="60"/>
            <count group_id="B3" value="60"/>
            <count group_id="B4" value="180"/>
          </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="70.8" spread="9.5"/>
                    <measurement group_id="B2" value="69.5" spread="9.1"/>
                    <measurement group_id="B3" value="69.5" spread="10.7"/>
                    <measurement group_id="B4" value="69.9" spread="9.8"/>
                  </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="41"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="112"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="68"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="13"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="121"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Oral Health Related Quality of Life</title>
          <description>The oral health related quality of life scale is a 14-item measurement of individuals' perceptions of the social impact of oral conditions on their well-being. Items are rated on a 5- point Likert type scale ranging from 0 (never) to 4 (very often), regarding how frequently impact has been experienced. The total score ranges from 0 to 56; higher OHIP-14 scores indicate greater impact, hence poorer oral-health-related quality of life.</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="11.1" spread="10.5"/>
                    <measurement group_id="B2" value="14.5" spread="13.4"/>
                    <measurement group_id="B3" value="16.3" spread="13.1"/>
                    <measurement group_id="B4" value="13.9" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self Efficacy</title>
          <description>Oral health self efficacy uses a 6 item scale and is a measurement of how confident seniors feel about their ability to perform oral hygiene tasks (1) under a lot of stress; (2) being depressed; (3) feeling anxious; (4) feeling that they were too busy; (5) being tired or; (6) being worried about other things in their life. The four response options range from 'very confident' to 'not at all confident'. The possible score range is 0 to 24,with high scores indicating high self-efficacy.</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="25.6" spread="6.5"/>
                    <measurement group_id="B2" value="23.5" spread="6.7"/>
                    <measurement group_id="B3" value="23.4" spread="7.4"/>
                    <measurement group_id="B4" value="24.2" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Oral Health Related Quality of Life (OHIP-14; Slade, 1997)</title>
        <description>The oral health related quality of life scale is a 14-item measurement of individuals' perceptions of the social impact of oral conditions on their well-being. This scale evaluates the consequences of oral conditions across dimensions of functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Items are rated on a 5- point Likert type scale ranging from 0 (never) to 4 (very often), regarding how frequently impact has been experienced. The total score ranges from 0 to 56; higher OHIP-14 scores indicate greater impact, hence poorer oral-health-related quality of life.</description>
        <time_frame>change from baseline to 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Regular dental care under the standard clinic operation</description>
          </group>
          <group group_id="O2">
            <title>Intervention 1</title>
            <description>Group based oral health education&#xD;
Oral Health Education: Group based oral health education vs Individual motivational interviewing</description>
          </group>
          <group group_id="O3">
            <title>Intervention 2</title>
            <description>Individual-based motivational interviewing&#xD;
Oral Health Education: Group based oral health education vs Individual motivational interviewing</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Oral Health Related Quality of Life (OHIP-14; Slade, 1997)</title>
          <description>The oral health related quality of life scale is a 14-item measurement of individuals' perceptions of the social impact of oral conditions on their well-being. This scale evaluates the consequences of oral conditions across dimensions of functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Items are rated on a 5- point Likert type scale ranging from 0 (never) to 4 (very often), regarding how frequently impact has been experienced. The total score ranges from 0 to 56; higher OHIP-14 scores indicate greater impact, hence poorer oral-health-related quality of life.</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="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8" spread="11.4"/>
                    <measurement group_id="O2" value="12.4" spread="11.2"/>
                    <measurement group_id="O3" value="10.5" spread="10.5"/>
                  </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>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>equivalence analysis</non_inferiority_desc>
            <p_value>.000</p_value>
            <p_value_desc>baseline demographics, correlated errors due to repeated measures, and bias due to lost to follow-up were accounted for via Generalized Estimating Equation (statistical threshold &lt;0.01)</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Mean change difference in oral health related quality of life among control, intervention 1: group-based oral health education and intervention 2: individual-based oral health education using motivational interviewing.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Oral Health Self Efficacy (Modified Version of Finlayson, 2007).</title>
        <description>Oral health self efficacy uses a 6 item scale and is a measurement of how confident seniors feel about their ability to perform oral hygiene tasks (1) under a lot of stress; (2) being depressed; (3) feeling anxious; (4) feeling that they were too busy; (5) being tired or; (6) being worried about other things in their life. The four response options range from 'very confident' to 'not at all confident'. The possible score range is 0 to 24,with high scores indicating high self-efficacy.</description>
        <time_frame>change from baseline to 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Regular dental care under the standard clinic operation</description>
          </group>
          <group group_id="O2">
            <title>Intervention 1</title>
            <description>Group based oral health education&#xD;
Oral Health Education: Group based oral health education vs Individual motivational interviewing</description>
          </group>
          <group group_id="O3">
            <title>Intervention 2</title>
            <description>Individual-based motivational interviewing&#xD;
Oral Health Education: Group based oral health education vs Individual motivational interviewing</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Oral Health Self Efficacy (Modified Version of Finlayson, 2007).</title>
          <description>Oral health self efficacy uses a 6 item scale and is a measurement of how confident seniors feel about their ability to perform oral hygiene tasks (1) under a lot of stress; (2) being depressed; (3) feeling anxious; (4) feeling that they were too busy; (5) being tired or; (6) being worried about other things in their life. The four response options range from 'very confident' to 'not at all confident'. The possible score range is 0 to 24,with high scores indicating high self-efficacy.</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="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.5" spread="6.6"/>
                    <measurement group_id="O2" value="24.5" spread="7.5"/>
                    <measurement group_id="O3" value="27.6" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Oral Health Knowledge (Khanagar, 2014)</title>
        <description>Oral health knowledge measurement of the seniors pre and post intervention will be conducted using a list of 15 knowledge statements to which subjects had to report agreement wit the statement (yes), disagreement (no) or don't know. The frequency numbers provided in the results table correspond to correct responses for each individual item.</description>
        <time_frame>change from baseline to 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control: Standard of Care</title>
            <description>Regular dental care under the standard clinic operation</description>
          </group>
          <group group_id="O2">
            <title>Intervention 1: Group-based Oral Health Education</title>
            <description>Group based oral health education&#xD;
Oral Health Education: Group-based oral health education vs Individual-based oral health education using motivational interviewing</description>
          </group>
          <group group_id="O3">
            <title>Intervention 2: Individual-based Oral Health Education</title>
            <description>Individual-based motivational interviewing&#xD;
Oral Health Education: Group-based oral health education vs Individual-based oral health education using motivational interviewing</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Oral Health Knowledge (Khanagar, 2014)</title>
          <description>Oral health knowledge measurement of the seniors pre and post intervention will be conducted using a list of 15 knowledge statements to which subjects had to report agreement wit the statement (yes), disagreement (no) or don't know. The frequency numbers provided in the results table correspond to correct responses for each individual item.</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="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>When gums bleed during brushing....</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>health of mouth directly related to body..</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>You can chew just as well with dentures as with</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Older adults with dry mouth get more cavities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The most common cause of dry mouth is medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>It is normal for people to have pain and sores in</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Individuals who do not cooperate for daily mouth c</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Name Box Insert Function Dental check-ups are as i</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="54"/>
                    <measurement group_id="O3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>People can lose their teeth if they remain dirty</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>As people get old they naturally lose their teeth</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dentures that don't fit well can cause oral cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dentures should be removed for few hours every day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>People with no teeth need to be seen by dentist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mouth rinsing is a good alternative to daily tooth</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Older adults with teeth need to use fluorides</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>No adverse event data were collected.</time_frame>
      <desc>No adverse event data were collected.Nature of intervention tested would not generate mortality outcomes.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>Regular dental care under the standard clinic operation</description>
        </group>
        <group group_id="E2">
          <title>Intervention 1</title>
          <description>Group based oral health education&#xD;
Oral Health Education: Group based oral health education vs Individual motivational interviewing</description>
        </group>
        <group group_id="E3">
          <title>Intervention 2</title>
          <description>Individual-based motivational interviewing&#xD;
Oral Health Education: Group based oral health education vs Individual motivational interviewing</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </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>Dr. Marisol Tellez Merchan</name_or_title>
      <organization>Kornber School of Dentistry</organization>
      <phone>2177071773</phone>
      <email>marisol@temple.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/NCT03301714
org study id: TempleU
nct id: NCT03301714
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to assess the efficacy of an oral health education group based activity versus
      an individual based oral health education activity in terms of changes in oral health related
      quality of life (OHRQoL), self-efficacy and oral health knowledge.
Older adults have been described as one of the most underserved and vulnerable groups, who
      are at the highest risk for coronal and root caries, especially because more elderly adults
      are retaining their teeth. The Northeast Philadelphia KleinLife site is an important
      destination for the region's Jewish population comprising of at least 6500 seniors, and
      assisting more than 4500 seniors through food security programs. Recently, Temple University
      Kornberg School of Dentistry (TUKSoD) purchased the dental center at the facility to expand
      the services provided to these underserved population and improve their oral health. The
      study aims to assess the efficacy of an oral health education group based activity versus an
      individual based oral health education activity in terms of changes in oral health related
      quality of life (OHRQoL), self-efficacy and oral health knowledge. Methods: A non-probability
      sample of 190 senior members will be invited to participate in the trial. Potential subjects
      will be obtained in person through the ongoing flow of patients at TUKSoD Clinic at Kleinlife
      and the dental school. Seniors who consent to participate in the study will be randomly
      allocated to one of the 3 groups (Control: subjects will continue receiving regular dental
      care at the clinic, Intervention 1: subjects will continue receiving regular dental care at
      the clinic and be invited to participate in 2 group based education sessions during a 12
      month period, and Intervention 2: subjects will continue receiving regular dental care at the
      clinic and be invited to participate in an individual-based education and prevention activity
      over a 18 month period. Randomization will be determined according to a predetermined random
      sequence, and neither the patient nor the research staff will be aware of the randomization
      outcome until after the patient has agreed to participate. The OHIP-14 will be used to assess
      OHRQoL, and self-efficacy scores will be the primary outcomes. Initially, we will assess the
      differences between the interventions and control using 2-sample t-tests. The main analysis
      will be based on linear mixed-effects models for repeated measures (using the OHIP 14 and
      self-efficacy scores as continuous outcome variables) to assess differences between
      intervention and control groups. Similar analyses will be conducted for secondary outcome
      measures Statistical significance will be set at p < .05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Oral Health Related Quality of Life (OHIP-14; Slade, 1997)
time frame: change from baseline to 12 months
description: The oral health related quality of life scale is a 14-item measurement of individuals' perceptions of the social impact of oral conditions on their well-being. This scale evaluates the consequences of oral conditions across dimensions of functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Items are rated on a 5- point Likert type scale ranging from 0 (never) to 4 (very often), regarding how frequently impact has been experienced. The total score ranges from 0 to 56; higher OHIP-14 scores indicate greater impact, hence poorer oral-health-related quality of life.
measure: Change in Oral Health Self Efficacy (Modified Version of Finlayson, 2007).
time frame: change from baseline to 12 months
description: Oral health self efficacy uses a 6 item scale and is a measurement of how confident seniors feel about their ability to perform oral hygiene tasks (1) under a lot of stress; (2) being depressed; (3) feeling anxious; (4) feeling that they were too busy; (5) being tired or; (6) being worried about other things in their life. The four response options range from 'very confident' to 'not at all confident'. The possible score range is 0 to 24,with high scores indicating high self-efficacy.
measure: Change in Oral Health Knowledge (Khanagar, 2014)
time frame: change from baseline to 12 months
description: Oral health knowledge measurement of the seniors pre and post intervention will be conducted using a list of 15 knowledge statements to which subjects had to report agreement wit the statement (yes), disagreement (no) or don't know. The frequency numbers provided in the results table correspond to correct responses for each individual item.
arm group label: Control: Standard of Care
arm group type: No Intervention
description: Regular dental care under the standard clinic operation
arm group label: Intervention 1: Group-based oral health education
arm group type: Experimental
description: Group based oral health education
arm group label: Intervention 2: Individual-based oral health education
arm group type: Experimental
description: Individual-based motivational interviewing
intervention type: Behavioral
intervention name: Oral Health Education
description: Group-based oral health education vs Individual-based oral health education using motivational interviewing
arm group label: Intervention 1: Group-based oral health education
arm group label: Intervention 2: Individual-based oral health education
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: MARISOL TELLEZ, PhD
role: Principal Investigator
affiliation: Associate Professor Temple University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 