<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/NCT03004911</url>
  </required_header>
  <id_info>
    <org_study_id>274/14</org_study_id>
    <nct_id>NCT03004911</nct_id>
  </id_info>
  <brief_title>Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia</brief_title>
  <official_title>Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo General Hospital</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 study is to test the efficacy of a mobile application named ProFibro to&#xD;
      promote self-care, and improve symptoms and health-related quality of life in Brazilian&#xD;
      patients with fibromyalgia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2017</start_date>
  <completion_date type="Actual">December 12, 2017</completion_date>
  <primary_completion_date type="Actual">December 12, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire</measure>
    <time_frame>6 weeks</time_frame>
    <description>Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Painful Areas Assessed With the Widespread Pain Index</measure>
    <time_frame>6 weeks</time_frame>
    <description>Minimum value: 0. Maximum value: 19.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Assessed With the Visual Analogue Scale</measure>
    <time_frame>6 weeks</time_frame>
    <description>Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Symptoms Assessed With the Symptom Severity Scale</measure>
    <time_frame>6 weeks</time_frame>
    <description>Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised</measure>
    <time_frame>6 weeks</time_frame>
    <description>Minimum value: 15. Maximum value: 75. Higher scores mean better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to Mobile Application Assessed by Number of Clicks on the App Functions</measure>
    <time_frame>6 weeks</time_frame>
    <description>Number of clicks on the app functions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Mobile application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Paper booklet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ProFibro (Mobile application)</intervention_name>
    <description>ProFibro, a mobile Android application in Brazilian Portuguese to promote self-care in patients with fibromyalgia</description>
    <arm_group_label>Mobile application</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Paper booklet</intervention_name>
    <description>A 64-page booklet with content similar to the mobile application</description>
    <arm_group_label>Paper booklet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of fibromyalgia, according to the 2010 American College of Rheumatology&#xD;
             diagnostic criteria&#xD;
&#xD;
          -  smartphone user&#xD;
&#xD;
          -  complete primary education&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  being in physical therapy treatment for fibromyalgia or having been treated in the&#xD;
             last 3 months&#xD;
&#xD;
          -  diagnosis of other chronic pain conditions (neuropathies, rheumatoid arthritis,&#xD;
             osteoarthritis, spinal stenosis or cancer)&#xD;
&#xD;
          -  severe mental disorders (schizophrenia, psychosis, bipolar affective disorder, severe&#xD;
             depression)&#xD;
&#xD;
          -  moderate or severe intellectual disability&#xD;
&#xD;
          -  hearing or visual impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan LK Yuan, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rehabilitation Sciences PhD program of the School of Medicine of the University of Sao Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amelia P Marques, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05360-160</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>https://profibro2018.wordpress.com/</url>
    <description>The website briefly explains the stages of the development of ProFibro, the main functions of the application and the test of its efficacy.</description>
  </link>
  <reference>
    <citation>Paiva ES, Heymann RE, Rezende MC, Helfenstein M Jr, Martinez JE, Provenza JR, Ranzolin A, de Assis MR, Pasqualin VD, Bennett RM. A Brazilian Portuguese version of the Revised Fibromyalgia Impact Questionnaire (FIQR): a validation study. Clin Rheumatol. 2013 Aug;32(8):1199-206. doi: 10.1007/s10067-013-2259-6. Epub 2013 Apr 21.</citation>
    <PMID>23604595</PMID>
  </reference>
  <reference>
    <citation>Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15.</citation>
    <PMID>19369473</PMID>
  </reference>
  <reference>
    <citation>Altman DG, Bland JM. How to randomise. BMJ. 1999 Sep 11;319(7211):703-4. doi: 10.1136/bmj.319.7211.703. No abstract available.</citation>
    <PMID>10480833</PMID>
  </reference>
  <reference>
    <citation>Henriksson C, Carlberg U, Kjallman M, Lundberg G, Henriksson KG. Evaluation of four outpatient educational programmes for patients with longstanding fibromyalgia. J Rehabil Med. 2004 Sep;36(5):211-9. doi: 10.1080/16501970410027494.</citation>
    <PMID>15626161</PMID>
  </reference>
  <reference>
    <citation>Nam S, Tin D, Bain L, Thorne JC, Ginsburg L. Clinical utility of the Hospital Anxiety and Depression Scale (HADS) for an outpatient fibromyalgia education program. Clin Rheumatol. 2014 May;33(5):685-92. doi: 10.1007/s10067-013-2377-1. Epub 2013 Sep 1.</citation>
    <PMID>23995734</PMID>
  </reference>
  <reference>
    <citation>Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10. Erratum In: Arthritis Res Ther. 2009;11(5):415.</citation>
    <PMID>19664287</PMID>
  </reference>
  <reference>
    <citation>Bennett R. The Fibromyalgia Impact Questionnaire (FIQ): a review of its development, current version, operating characteristics and uses. Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S154-62.</citation>
    <PMID>16273800</PMID>
  </reference>
  <reference>
    <citation>Marques AP, Assumpcao A, Matsutani LA, Pereira CA, Lage L. Pain in fibromyalgia and discrimination power of the instruments: Visual Analog Scale, Dolorimetry and the McGill Pain Questionnaire. Acta Reumatol Port. 2008 Jul-Sep;33(3):345-51.</citation>
    <PMID>18846013</PMID>
  </reference>
  <reference>
    <citation>Sousa VD, Zauszniewski JA, Bergquist-Beringer S, Musil CM, Neese JB, Jaber AF. Reliability, validity and factor structure of the Appraisal of Self-Care Agency Scale-Revised (ASAS-R). J Eval Clin Pract. 2010 Dec;16(6):1031-40. doi: 10.1111/j.1365-2753.2009.01242.x.</citation>
    <PMID>20626539</PMID>
  </reference>
  <reference>
    <citation>Damasio BF, Koller SH. The Appraisal of Self-Care Agency Scale - Revised (ASAS-R): adaptation and construct validity in the Brazilian context. Cad Saude Publica. 2013 Oct;29(10):2071-82. doi: 10.1590/0102-311x00165312.</citation>
    <PMID>24127101</PMID>
  </reference>
  <reference>
    <citation>Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.</citation>
    <PMID>20461783</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <results_first_submitted>December 4, 2018</results_first_submitted>
  <results_first_submitted_qc>March 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 17, 2019</results_first_posted>
  <last_update_submitted>March 18, 2019</last_update_submitted>
  <last_update_submitted_qc>March 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fibromyalgia</keyword>
  <keyword>mobile application</keyword>
  <keyword>self-care</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 14, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03004911/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mobile Application</title>
          <description>The use of ProFibro mobile application for six weeks</description>
        </group>
        <group group_id="P2">
          <title>Paper Booklet</title>
          <description>The use of a 64-page booklet (with content similar to the mobile application) for six weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mobile Application</title>
          <description>The use of ProFibro app for 6 weeks</description>
        </group>
        <group group_id="B2">
          <title>Paper Booklet</title>
          <description>The use of the booklet for 6 weeks</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="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.3" spread="8.4"/>
                    <measurement group_id="B2" value="42.1" spread="11.8"/>
                    <measurement group_id="B3" value="42.7" spread="10.1"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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 and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Brazil</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire</title>
          <description>Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.6" spread="16.8"/>
                    <measurement group_id="B2" value="65.4" spread="18"/>
                    <measurement group_id="B3" value="64" spread="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Painful Areas Assessed With the Widespread Pain Index</title>
          <description>Minimum value: 0. Maximum value: 19.</description>
          <units>number of painful areas</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.6" spread="4"/>
                    <measurement group_id="B2" value="13.6" spread="3.7"/>
                    <measurement group_id="B3" value="13.6" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pain Assessed With the Visual Analogue Scale</title>
          <description>Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.9" spread="2.2"/>
                    <measurement group_id="B2" value="5.7" spread="2.2"/>
                    <measurement group_id="B3" value="5.8" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Severity of Symptoms Assessed With the Symptom Severity Scale</title>
          <description>Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.4" spread="1.5"/>
                    <measurement group_id="B2" value="9.2" spread="1.9"/>
                    <measurement group_id="B3" value="9.3" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised</title>
          <description>Minimum value: 15. Maximum value: 75. Higher scores mean better outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.9" spread="9.7"/>
                    <measurement group_id="B2" value="53.5" spread="11"/>
                    <measurement group_id="B3" value="52.7" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire</title>
        <description>Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Application</title>
            <description>The use of ProFibro app for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Paper Booklet</title>
            <description>The use of the booklet for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire</title>
          <description>Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.</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="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.7" spread="17.1"/>
                    <measurement group_id="O2" value="55.5" spread="18.2"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.740</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Painful Areas Assessed With the Widespread Pain Index</title>
        <description>Minimum value: 0. Maximum value: 19.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Application</title>
            <description>The use of ProFibro app for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Paper Booklet</title>
            <description>The use of the booklet for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Painful Areas Assessed With the Widespread Pain Index</title>
          <description>Minimum value: 0. Maximum value: 19.</description>
          <units>number of painful areas</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="4.6"/>
                    <measurement group_id="O2" value="12.3" spread="4.5"/>
                  </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_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.890</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Assessed With the Visual Analogue Scale</title>
        <description>Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Application</title>
            <description>The use of ProFibro app for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Paper Booklet</title>
            <description>The use of the booklet for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Assessed With the Visual Analogue Scale</title>
          <description>Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.</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="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="2.6"/>
                    <measurement group_id="O2" value="5.3" spread="2.3"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.747</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of Symptoms Assessed With the Symptom Severity Scale</title>
        <description>Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Application</title>
            <description>The use of ProFibro app for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Paper Booklet</title>
            <description>The use of the booklet for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Symptoms Assessed With the Symptom Severity Scale</title>
          <description>Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.</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="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="2.9"/>
                    <measurement group_id="O2" value="7.6" spread="2.4"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.000</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised</title>
        <description>Minimum value: 15. Maximum value: 75. Higher scores mean better outcome.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Application</title>
            <description>The use of ProFibro app for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Paper Booklet</title>
            <description>The use of the booklet for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised</title>
          <description>Minimum value: 15. Maximum value: 75. Higher scores mean better outcome.</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="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.8" spread="10.2"/>
                    <measurement group_id="O2" value="54.3" spread="11"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.459</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adherence to Mobile Application Assessed by Number of Clicks on the App Functions</title>
        <description>Number of clicks on the app functions</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Application</title>
            <description>The use of ProFibro app for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence to Mobile Application Assessed by Number of Clicks on the App Functions</title>
          <description>Number of clicks on the app functions</description>
          <units>Clicks on app functions</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106" lower_limit="12" upper_limit="237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Mobile Application</title>
          <description>The use of ProFibro app for 6 weeks</description>
        </group>
        <group group_id="E2">
          <title>Paper Booklet</title>
          <description>The use of the booklet for 6 weeks</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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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>Amélia Pasqual Marques</name_or_title>
      <organization>School of Medicine at the University of Sao Paulo</organization>
      <phone>+55 11 3091 7451</phone>
      <email>pasqual@usp.br</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/NCT03004911
org study id: 274/14
nct id: NCT03004911
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the efficacy of a mobile application named ProFibro to
      promote self-care, and improve symptoms and health-related quality of life in Brazilian
      patients with fibromyalgia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire
time frame: 6 weeks
description: Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.
measure: Number of Painful Areas Assessed With the Widespread Pain Index
time frame: 6 weeks
description: Minimum value: 0. Maximum value: 19.
measure: Pain Assessed With the Visual Analogue Scale
time frame: 6 weeks
description: Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.
measure: Severity of Symptoms Assessed With the Symptom Severity Scale
time frame: 6 weeks
description: Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.
measure: Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised
time frame: 6 weeks
description: Minimum value: 15. Maximum value: 75. Higher scores mean better outcome.
measure: Adherence to Mobile Application Assessed by Number of Clicks on the App Functions
time frame: 6 weeks
description: Number of clicks on the app functions
arm group label: Mobile application
arm group type: Experimental
arm group label: Paper booklet
arm group type: Active Comparator
intervention type: Device
intervention name: ProFibro (Mobile application)
description: ProFibro, a mobile Android application in Brazilian Portuguese to promote self-care in patients with fibromyalgia
arm group label: Mobile application
intervention type: Device
intervention name: Paper booklet
description: A 64-page booklet with content similar to the mobile application
arm group label: Paper booklet
criteria: 
gender: All
minimum age: 19 Years
maximum age: 59 Years
healthy volunteers: No
last name: Susan LK Yuan, MSc
role: Principal Investigator
affiliation: Rehabilitation Sciences PhD program of the School of Medicine of the University of Sao Paulo
last name: Amelia P Marques, PhD
role: Study Chair
affiliation: Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo
facility: 
country: Brazil
url: https://profibro2018.wordpress.com/
description: The website briefly explains the stages of the development of ProFibro, the main functions of the application and the test of its efficacy.
citation: Paiva ES, Heymann RE, Rezende MC, Helfenstein M Jr, Martinez JE, Provenza JR, Ranzolin A, de Assis MR, Pasqualin VD, Bennett RM. A Brazilian Portuguese version of the Revised Fibromyalgia Impact Questionnaire (FIQR): a validation study. Clin Rheumatol. 2013 Aug;32(8):1199-206. doi: 10.1007/s10067-013-2259-6. Epub 2013 Apr 21.
PMID: 23604595
citation: Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15.
PMID: 19369473
citation: Altman DG, Bland JM. How to randomise. BMJ. 1999 Sep 11;319(7211):703-4. doi: 10.1136/bmj.319.7211.703. No abstract available.
PMID: 10480833
citation: Henriksson C, Carlberg U, Kjallman M, Lundberg G, Henriksson KG. Evaluation of four outpatient educational programmes for patients with longstanding fibromyalgia. J Rehabil Med. 2004 Sep;36(5):211-9. doi: 10.1080/16501970410027494.
PMID: 15626161
citation: Nam S, Tin D, Bain L, Thorne JC, Ginsburg L. Clinical utility of the Hospital Anxiety and Depression Scale (HADS) for an outpatient fibromyalgia education program. Clin Rheumatol. 2014 May;33(5):685-92. doi: 10.1007/s10067-013-2377-1. Epub 2013 Sep 1.
PMID: 23995734
citation: Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10. Erratum In: Arthritis Res Ther. 2009;11(5):415.
PMID: 19664287
citation: Bennett R. The Fibromyalgia Impact Questionnaire (FIQ): a review of its development, current version, operating characteristics and uses. Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S154-62.
PMID: 16273800
citation: Marques AP, Assumpcao A, Matsutani LA, Pereira CA, Lage L. Pain in fibromyalgia and discrimination power of the instruments: Visual Analog Scale, Dolorimetry and the McGill Pain Questionnaire. Acta Reumatol Port. 2008 Jul-Sep;33(3):345-51.
PMID: 18846013
citation: Sousa VD, Zauszniewski JA, Bergquist-Beringer S, Musil CM, Neese JB, Jaber AF. Reliability, validity and factor structure of the Appraisal of Self-Care Agency Scale-Revised (ASAS-R). J Eval Clin Pract. 2010 Dec;16(6):1031-40. doi: 10.1111/j.1365-2753.2009.01242.x.
PMID: 20626539
citation: Damasio BF, Koller SH. The Appraisal of Self-Care Agency Scale - Revised (ASAS-R): adaptation and construct validity in the Brazilian context. Cad Saude Publica. 2013 Oct;29(10):2071-82. doi: 10.1590/0102-311x00165312.
PMID: 24127101
citation: Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
PMID: 20461783
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 