<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/NCT02200068</url>
  </required_header>
  <id_info>
    <org_study_id>2013-A00105-40</org_study_id>
    <nct_id>NCT02200068</nct_id>
  </id_info>
  <brief_title>CARNet : Self-Monitoring and Co-driving in Rheumatology With Internet : Rheumatoid Arthritis Cohort (Usual Care Study)</brief_title>
  <acronym>CARNet</acronym>
  <official_title>Usual Care Randomized Study Measuring the Impact of an Online Personal Health Record (Sanoia) in Rheumatoid Arthritis Patients on Reported Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UCB France S.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Association Accompagnement pour un Internet en Médecine et Santé au Service des Usagers</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recommendations of Rheumatoid Arthritis management agree on the necessity of patient&#xD;
      self-involvement in the care. In parallel, the observation of the adoption rate of websites&#xD;
      directed toward patients may indicate that this involvement is shared by a large number ot&#xD;
      the population.&#xD;
&#xD;
      However, most of these sites are only informative and few of them offer patients to be&#xD;
      engaged to generate their own data that can impact on the patient-physician relationship by&#xD;
      easing the dialog and then leading to better mutual understanding.&#xD;
&#xD;
      As new web or mobile services allowing patients to self-report their outcomes are flourishing&#xD;
      only a very few of them have already addressed the their impact of the patient-physician&#xD;
      relationship.&#xD;
&#xD;
      The main objective of this study is to quantify the effect of a website (Sanoia) on the&#xD;
      quality of patient-doctor interactions, as perceived by the patient using the french&#xD;
      translations of the Peppi Questionnaire during the 12 months observation period.&#xD;
&#xD;
      In France, the patient protection committee (CPP) has ranked this study in &quot;Soins Courants&quot;&#xD;
      (Usual Care).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recommendations of care in rheumatoid arthritis (RA) advocate for patient involvement and&#xD;
      management of his/her own health.&#xD;
&#xD;
      The observation of the sole rate of use of websites specialized health patients might&#xD;
      indicate that this involvement is occurring for a large number. Indeed, yet in 2010, more&#xD;
      than 71% of French Netizen used the Internet to search for information related to their&#xD;
      health according to a 2012 survey from the French National Order of Medical Doctors. Focusing&#xD;
      on rheumatology, 68% of French patients have already used the Internet to search for&#xD;
      information related to their arthritis as shown from a 2012 survey of the French Society of&#xD;
      Rheumatology. In this medical field, these results reflect the fact that in France since&#xD;
      years 2000, patients' associations and institutions, edited websites to offer patients a&#xD;
      direct and easier access to information on diseases or treatments.&#xD;
&#xD;
      Nevertheless, it is useful to observe the type of service provided to the patient on these&#xD;
      sites: the majority of these sites, even the most recent offer only the dissemination of&#xD;
      information and never have been studied on this informative nature. These sites should be&#xD;
      considered as an introductory step toward patient involvement.&#xD;
&#xD;
      Indeed, patients involvement is effective if they are really &quot;active&quot; and produce data, e.g.&#xD;
      when him(her)self notes personal information online, manages a 'health book' virtual or&#xD;
      self-assessing internet. In other words, involvement makes sense when it contributes to an&#xD;
      &quot;improvement&quot; doctor-patient exchanges and when at last it leads to an increase in entropy.&#xD;
&#xD;
      Especially the latter type of use, i.e. the patient self-reported measure (patient-reported&#xD;
      outcomes), can be a manner to both involve the patient in his care, and to feed the medical&#xD;
      decision support with the certified rheumatologist. Moreover, it appears that the&#xD;
      self-measurements in particular by the RA patient, are reliable.&#xD;
&#xD;
      In recent years, new services on the web or mobile begun to address this need and allowed&#xD;
      patients to report issues relating to their health (current treatments, etc..), and to&#xD;
      perform self-measures (pain, activity, morning stiffness, etc..). Notwithstanding visibility&#xD;
      increasingly strong, it is striking to note that these tools, including those for&#xD;
      self-measurement, have been little evaluated in terms of impact, for example on&#xD;
      doctor-patient exchanges.&#xD;
&#xD;
      Indeed, Investigators have chosen to measure the characteristics of these exchanges, as&#xD;
      perceived by the patient: effectiveness, quality and overall quality of care using dedicated&#xD;
      tools.&#xD;
&#xD;
      In France, the patient protection committee (CPP) has ranked this study in &quot;Soins Courants&quot;&#xD;
      (Usual Care).&#xD;
&#xD;
      The study will use the web-based platform (*) Sanoia.com, partner of the French Society of&#xD;
      Rheumatology, which provides a trusted environment to its users via anonymity. This platform&#xD;
      is recognized as innovative by the French Ministry of Research and relies on a data hosting&#xD;
      architecture approved by the Ministry of Health. The statistical analysis of users data is&#xD;
      limited to research purposes and placed under the dual supervision of patient associations&#xD;
      and medical societies. These features are the source of its success in terms of audience with&#xD;
      patients (&gt; 145,000 health records created in September 2012).&#xD;
&#xD;
      Specifically Sanoia offers, among other benefits, Rheumatoid Arthritis (RA) patients to list&#xD;
      their medical history and access to tools for self-measures, whether generic (e.g. notepad&#xD;
      symptoms, followed by medications taken, etc.), or more specific to RA (e.g. RAPID3: routine&#xD;
      assessment of patient index data, Health Assessment Questionnaire, Rheumatoid Arthritis&#xD;
      Impact of Disease (RAID) score. Based on these data, a customized selection of information&#xD;
      (based on an Internet monitoring performed by patient association ANDAR and validated by the&#xD;
      medical society SFR) is displayed.&#xD;
&#xD;
      The main objective of this study is to quantify with RA patients the effect of a website&#xD;
      (Sanoia) on the quality of patient-doctor interactions, as perceived by the patient using the&#xD;
      french translations of the physician investigator to investigate the perceived efficacy ot&#xD;
      the patient-physician relationship (PEPPI) Questionnaire during the 12 months observation&#xD;
      period.&#xD;
&#xD;
      (*) : SANOIA is a personal health record platform that does not embed or to connect to social&#xD;
      networks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline to 12 months after inclusion of Perceived efficacy by the patient of patient-physician interactions (PEPPI)</measure>
    <time_frame>Baseline and Month 12</time_frame>
    <description>Patients connects to the electronic Case Report Form (e-CRF) and file the French translation of the 5-item PEPPI Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rheumatoid Arthritis Impact of Disease (RAID) score</measure>
    <time_frame>Baseline, Month 3, Month 6 and Month 12</time_frame>
    <description>Patients connects to the e-CRF and file the French translation of the Rheumatoid Arthritis Impact of Disease (RAID) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall assessment of the patient's Health as measured by a VAS</measure>
    <time_frame>Baseline, Month 3, Month 6 and Month 12</time_frame>
    <description>Patients connects to the e-CRF and move a cursor on the appropriate value on a Visual Analogic Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Physician communication quality, as assessed by the patient using a Numeric Rating Scale</measure>
    <time_frame>Baseline, Month 3, Month 6 and Month 12</time_frame>
    <description>Patients connects to the e-CRF and selects the appropriate number on a Numeric Rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall perceived quality of care, as assessed by the patient via a Numeric Rating Scale</measure>
    <time_frame>Baseline, Month 3, Month 6 and Month 12</time_frame>
    <description>Patients connects to the e-CRF and selects the appropriate number on a Numeric Rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient's visits to the Rheumatologist from baseline to 12 months after inclusion</measure>
    <time_frame>Month 3, Month 6 and Month 12</time_frame>
    <description>Patient reports the number of visits to the Rheumatologist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of SANOIA using a Numeric Rating Scale for the PHR Group</measure>
    <time_frame>Month 3 and Month 12</time_frame>
    <description>Patients connects to the e-CRF and selects the appropriate number on a Numeric Rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unsatisfactory criteria using a pre-defined list for the PHR Group</measure>
    <time_frame>Month 3 and Month 12</time_frame>
    <description>Patients connects to the e-CRF and selects the appropriate items in a list of pre-defined criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spontaneous access and use of SANOIA for Non-PHR Group (usual care)</measure>
    <time_frame>Month 12</time_frame>
    <description>Time period and origin of access of Group 2 Patients (usual care) that incidentally used SANOIA prior or during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Assessment Quality of Life Disability Index Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>Patients connects to the e-CRF and file the French translation of the Health Assessment Quality of Life Disability Index Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Co-morbidities list</measure>
    <time_frame>Baseline</time_frame>
    <description>Patients connects to the e-CRF and file the French translation of the 15 item (12 compulsory answers and 3 additional open items) of an adapted Comorbidities Questionnaire</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Value of Perceived efficacy by the patient of patient-physician interactions (PEPPI)</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>Patients connects to the electronic Case Report Form (e-CRF) and file the French translation of the 5-item PEPPI Questionnaire</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>PHR Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will have access to a personal health record website SANOIA in addition to all resources they use or find online</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-PHR Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will not be informed of the Personal Health Record Website and will use Internet as they usually do.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SANOIA Website</intervention_name>
    <arm_group_label>PHR Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult over 18 years.&#xD;
&#xD;
          -  Patient with Rheumatoid Arthritis diagnosed according to American College of&#xD;
             Rheumatology (ACR ) / European League Against Rheumatism (EULAR) 2010 criteria.&#xD;
&#xD;
          -  Patient monitored by the recruiting physician from over a year.&#xD;
&#xD;
          -  Patient access who have access to an Internet broadband equipment other than on a&#xD;
             mobile or a a smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient already using Sanoia at the time of inclusion.&#xD;
&#xD;
          -  Patient already participating in a therapeutic clinical trial in rheumatology&#xD;
&#xD;
          -  Patient having no computer literacy and understanding difficulties&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu de La Cavale Blanche</name>
      <address>
        <city>Brest</city>
        <zip>29069</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Gabriel-Montpied</name>
      <address>
        <city>Clermond-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Grenoble - Hôpital Sud</name>
      <address>
        <city>Echirolles</city>
        <zip>38434</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Le Mans Regional Hospital</name>
      <address>
        <city>Le Mans</city>
        <zip>72000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Rheumatologist</name>
      <address>
        <city>Mantes-La-Jolie</city>
        <zip>78200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Lapeyronie</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Hotel-Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Saint-Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital La Pitié Salpétrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Sud</name>
      <address>
        <city>Rennes</city>
        <zip>35203</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Purpan</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998 Jul;46(7):889-94. doi: 10.1111/j.1532-5415.1998.tb02725.x.</citation>
    <PMID>9670878</PMID>
  </reference>
  <reference>
    <citation>Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010 Sep;69(9):1580-8. doi: 10.1136/ard.2010.138461. Erratum In: Ann Rheum Dis. 2010 Oct;69(10):1892.</citation>
    <PMID>20699241</PMID>
  </reference>
  <reference>
    <citation>Gossec L, Dougados M, Rincheval N, Balanescu A, Boumpas DT, Canadelo S, Carmona L, Daures JP, de Wit M, Dijkmans BA, Englbrecht M, Gunendi Z, Heiberg T, Kirwan JR, Mola EM, Matucci-Cerinic M, Otsa K, Schett G, Sokka T, Wells GA, Aanerud GJ, Celano A, Dudkin A, Hernandez C, Koutsogianni K, Akca FN, Petre AM, Richards P, Scholte-Voshaar M, Von Krause G, Kvien TK. Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative. Ann Rheum Dis. 2009 Nov;68(11):1680-5. doi: 10.1136/ard.2008.100271. Epub 2008 Dec 3.</citation>
    <PMID>19054825</PMID>
  </reference>
  <reference>
    <citation>Pincus T, Bergman MJ, Yazici Y, Hines P, Raghupathi K, Maclean R. An index of only patient-reported outcome measures, routine assessment of patient index data 3 (RAPID3), in two abatacept clinical trials: similar results to disease activity score (DAS28) and other RAPID indices that include physician-reported measures. Rheumatology (Oxford). 2008 Mar;47(3):345-9. doi: 10.1093/rheumatology/kem364. Epub 2008 Jan 31.</citation>
    <PMID>18238788</PMID>
  </reference>
  <reference>
    <citation>Guillemin F, Braincon S, Pourel J. [Measurement of the functional capacity in rheumatoid polyarthritis: a French adaptation of the Health Assessment Questionnaire (HAQ)]. Rev Rhum Mal Osteoartic. 1991 Jun;58(6):459-65. French.</citation>
    <PMID>1896787</PMID>
  </reference>
  <reference>
    <citation>Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, Emery P, Gaujoux-Viala C, Gossec L, Nam J, Ramiro S, Winthrop K, de Wit M, Aletaha D, Betteridge N, Bijlsma JW, Boers M, Buttgereit F, Combe B, Cutolo M, Damjanov N, Hazes JM, Kouloumas M, Kvien TK, Mariette X, Pavelka K, van Riel PL, Rubbert-Roth A, Scholte-Voshaar M, Scott DL, Sokka-Isler T, Wong JB, van der Heijde D. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014 Mar;73(3):492-509. doi: 10.1136/annrheumdis-2013-204573. Epub 2013 Oct 25.</citation>
    <PMID>24161836</PMID>
  </reference>
  <reference>
    <citation>Bossert M, Prati C, Vidal C, Bongain S, Toussirot E, Wendling D. Evaluation of self-report questionnaires for assessing rheumatoid arthritis activity: a cross-sectional study of RAPID3 and RADAI5 and flare detection in 200 patients. Joint Bone Spine. 2012 Jan;79(1):57-62. doi: 10.1016/j.jbspin.2011.03.014. Epub 2011 May 6.</citation>
    <PMID>21550283</PMID>
  </reference>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>June 17, 2016</last_update_submitted>
  <last_update_submitted_qc>June 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Perceived Efficacy of Patient Physician Interactions</keyword>
  <keyword>Patient Reported Outcomes</keyword>
  <keyword>Personal Health Record</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02200068
org study id: 2013-A00105-40
nct id: NCT02200068
lead sponsor: 
collaborator: 
has dmc: No
Recommendations of Rheumatoid Arthritis management agree on the necessity of patient
      self-involvement in the care. In parallel, the observation of the adoption rate of websites
      directed toward patients may indicate that this involvement is shared by a large number ot
      the population.

      However, most of these sites are only informative and few of them offer patients to be
      engaged to generate their own data that can impact on the patient-physician relationship by
      easing the dialog and then leading to better mutual understanding.

      As new web or mobile services allowing patients to self-report their outcomes are flourishing
      only a very few of them have already addressed the their impact of the patient-physician
      relationship.

      The main objective of this study is to quantify the effect of a website (Sanoia) on the
      quality of patient-doctor interactions, as perceived by the patient using the french
      translations of the Peppi Questionnaire during the 12 months observation period.

      In France, the patient protection committee (CPP) has ranked this study in "Soins Courants"
      (Usual Care).
Recommendations of care in rheumatoid arthritis (RA) advocate for patient involvement and
      management of his/her own health.

      The observation of the sole rate of use of websites specialized health patients might
      indicate that this involvement is occurring for a large number. Indeed, yet in 2010, more
      than 71% of French Netizen used the Internet to search for information related to their
      health according to a 2012 survey from the French National Order of Medical Doctors. Focusing
      on rheumatology, 68% of French patients have already used the Internet to search for
      information related to their arthritis as shown from a 2012 survey of the French Society of
      Rheumatology. In this medical field, these results reflect the fact that in France since
      years 2000, patients' associations and institutions, edited websites to offer patients a
      direct and easier access to information on diseases or treatments.

      Nevertheless, it is useful to observe the type of service provided to the patient on these
      sites: the majority of these sites, even the most recent offer only the dissemination of
      information and never have been studied on this informative nature. These sites should be
      considered as an introductory step toward patient involvement.

      Indeed, patients involvement is effective if they are really "active" and produce data, e.g.
      when him(her)self notes personal information online, manages a 'health book' virtual or
      self-assessing internet. In other words, involvement makes sense when it contributes to an
      "improvement" doctor-patient exchanges and when at last it leads to an increase in entropy.

      Especially the latter type of use, i.e. the patient self-reported measure (patient-reported
      outcomes), can be a manner to both involve the patient in his care, and to feed the medical
      decision support with the certified rheumatologist. Moreover, it appears that the
      self-measurements in particular by the RA patient, are reliable.

      In recent years, new services on the web or mobile begun to address this need and allowed
      patients to report issues relating to their health (current treatments, etc..), and to
      perform self-measures (pain, activity, morning stiffness, etc..). Notwithstanding visibility
      increasingly strong, it is striking to note that these tools, including those for
      self-measurement, have been little evaluated in terms of impact, for example on
      doctor-patient exchanges.

      Indeed, Investigators have chosen to measure the characteristics of these exchanges, as
      perceived by the patient: effectiveness, quality and overall quality of care using dedicated
      tools.

      In France, the patient protection committee (CPP) has ranked this study in "Soins Courants"
      (Usual Care).

      The study will use the web-based platform (*) Sanoia.com, partner of the French Society of
      Rheumatology, which provides a trusted environment to its users via anonymity. This platform
      is recognized as innovative by the French Ministry of Research and relies on a data hosting
      architecture approved by the Ministry of Health. The statistical analysis of users data is
      limited to research purposes and placed under the dual supervision of patient associations
      and medical societies. These features are the source of its success in terms of audience with
      patients (> 145,000 health records created in September 2012).

      Specifically Sanoia offers, among other benefits, Rheumatoid Arthritis (RA) patients to list
      their medical history and access to tools for self-measures, whether generic (e.g. notepad
      symptoms, followed by medications taken, etc.), or more specific to RA (e.g. RAPID3: routine
      assessment of patient index data, Health Assessment Questionnaire, Rheumatoid Arthritis
      Impact of Disease (RAID) score. Based on these data, a customized selection of information
      (based on an Internet monitoring performed by patient association ANDAR and validated by the
      medical society SFR) is displayed.

      The main objective of this study is to quantify with RA patients the effect of a website
      (Sanoia) on the quality of patient-doctor interactions, as perceived by the patient using the
      french translations of the physician investigator to investigate the perceived efficacy ot
      the patient-physician relationship (PEPPI) Questionnaire during the 12 months observation
      period.

      (*) : SANOIA is a personal health record platform that does not embed or to connect to social
      networks.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: Change from Baseline to 12 months after inclusion of Perceived efficacy by the patient of patient-physician interactions (PEPPI)
time frame: Baseline and Month 12
description: Patients connects to the electronic Case Report Form (e-CRF) and file the French translation of the 5-item PEPPI Questionnaire
measure: Rheumatoid Arthritis Impact of Disease (RAID) score
time frame: Baseline, Month 3, Month 6 and Month 12
description: Patients connects to the e-CRF and file the French translation of the Rheumatoid Arthritis Impact of Disease (RAID) score
measure: Overall assessment of the patient's Health as measured by a VAS
time frame: Baseline, Month 3, Month 6 and Month 12
description: Patients connects to the e-CRF and move a cursor on the appropriate value on a Visual Analogic Scale
measure: Patient-Physician communication quality, as assessed by the patient using a Numeric Rating Scale
time frame: Baseline, Month 3, Month 6 and Month 12
description: Patients connects to the e-CRF and selects the appropriate number on a Numeric Rating scale
measure: Overall perceived quality of care, as assessed by the patient via a Numeric Rating Scale
time frame: Baseline, Month 3, Month 6 and Month 12
description: Patients connects to the e-CRF and selects the appropriate number on a Numeric Rating scale
measure: Number of patient's visits to the Rheumatologist from baseline to 12 months after inclusion
time frame: Month 3, Month 6 and Month 12
description: Patient reports the number of visits to the Rheumatologist
measure: Satisfaction of SANOIA using a Numeric Rating Scale for the PHR Group
time frame: Month 3 and Month 12
description: Patients connects to the e-CRF and selects the appropriate number on a Numeric Rating scale
measure: Unsatisfactory criteria using a pre-defined list for the PHR Group
time frame: Month 3 and Month 12
description: Patients connects to the e-CRF and selects the appropriate items in a list of pre-defined criteria
measure: Spontaneous access and use of SANOIA for Non-PHR Group (usual care)
time frame: Month 12
description: Time period and origin of access of Group 2 Patients (usual care) that incidentally used SANOIA prior or during the study
measure: Health Assessment Quality of Life Disability Index Questionnaire
time frame: Baseline
description: Patients connects to the e-CRF and file the French translation of the Health Assessment Quality of Life Disability Index Questionnaire
measure: Co-morbidities list
time frame: Baseline
description: Patients connects to the e-CRF and file the French translation of the 15 item (12 compulsory answers and 3 additional open items) of an adapted Comorbidities Questionnaire
measure: Value of Perceived efficacy by the patient of patient-physician interactions (PEPPI)
time frame: Month 3 and Month 6
description: Patients connects to the electronic Case Report Form (e-CRF) and file the French translation of the 5-item PEPPI Questionnaire
arm group label: PHR Group
arm group type: Active Comparator
description: This group will have access to a personal health record website SANOIA in addition to all resources they use or find online
arm group label: Non-PHR Group
arm group type: No Intervention
description: This group will not be informed of the Personal Health Record Website and will use Internet as they usually do.
intervention type: Other
intervention name: SANOIA Website
arm group label: PHR Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: France
citation: Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998 Jul;46(7):889-94. doi: 10.1111/j.1532-5415.1998.tb02725.x.
PMID: 9670878
citation: Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010 Sep;69(9):1580-8. doi: 10.1136/ard.2010.138461. Erratum In: Ann Rheum Dis. 2010 Oct;69(10):1892.
PMID: 20699241
citation: Gossec L, Dougados M, Rincheval N, Balanescu A, Boumpas DT, Canadelo S, Carmona L, Daures JP, de Wit M, Dijkmans BA, Englbrecht M, Gunendi Z, Heiberg T, Kirwan JR, Mola EM, Matucci-Cerinic M, Otsa K, Schett G, Sokka T, Wells GA, Aanerud GJ, Celano A, Dudkin A, Hernandez C, Koutsogianni K, Akca FN, Petre AM, Richards P, Scholte-Voshaar M, Von Krause G, Kvien TK. Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative. Ann Rheum Dis. 2009 Nov;68(11):1680-5. doi: 10.1136/ard.2008.100271. Epub 2008 Dec 3.
PMID: 19054825
citation: Pincus T, Bergman MJ, Yazici Y, Hines P, Raghupathi K, Maclean R. An index of only patient-reported outcome measures, routine assessment of patient index data 3 (RAPID3), in two abatacept clinical trials: similar results to disease activity score (DAS28) and other RAPID indices that include physician-reported measures. Rheumatology (Oxford). 2008 Mar;47(3):345-9. doi: 10.1093/rheumatology/kem364. Epub 2008 Jan 31.
PMID: 18238788
citation: Guillemin F, Braincon S, Pourel J. [Measurement of the functional capacity in rheumatoid polyarthritis: a French adaptation of the Health Assessment Questionnaire (HAQ)]. Rev Rhum Mal Osteoartic. 1991 Jun;58(6):459-65. French.
PMID: 1896787
citation: Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, Emery P, Gaujoux-Viala C, Gossec L, Nam J, Ramiro S, Winthrop K, de Wit M, Aletaha D, Betteridge N, Bijlsma JW, Boers M, Buttgereit F, Combe B, Cutolo M, Damjanov N, Hazes JM, Kouloumas M, Kvien TK, Mariette X, Pavelka K, van Riel PL, Rubbert-Roth A, Scholte-Voshaar M, Scott DL, Sokka-Isler T, Wong JB, van der Heijde D. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014 Mar;73(3):492-509. doi: 10.1136/annrheumdis-2013-204573. Epub 2013 Oct 25.
PMID: 24161836
citation: Bossert M, Prati C, Vidal C, Bongain S, Toussirot E, Wendling D. Evaluation of self-report questionnaires for assessing rheumatoid arthritis activity: a cross-sectional study of RAPID3 and RADAI5 and flare detection in 200 patients. Joint Bone Spine. 2012 Jan;79(1):57-62. doi: 10.1016/j.jbspin.2011.03.014. Epub 2011 May 6.
PMID: 21550283
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid