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<docDscr>
  <citation>
    <titlStmt>
      <titl>Evaluation of the Effectiveness of a Digital Device for Remote Monitoring of Adapted Physical Activity in Patients with Chronic Diseases</titl>
      <IDNo>FReSH-59394-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="" role="">test SGsix</producer>
    </prodStmt>
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      <version></version>
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  </citation>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Evaluation of the Effectiveness of a Digital Device for Remote Monitoring of Adapted Physical Activity in Patients with Chronic Diseases            </titl>
      <altTitl>
                    TELE-APA                </altTitl>
      <IDNo agency="FReSH-lang">
                FReSH-59394-en            </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Walma Gharbi                                                <ExtLink title="ORCID" URI="0000-0002-1825-0097" role="pi id"/>
                                                                                                                    <ExtLink title="IdRef" URI="061089842" role="pi id"/>
                                                                                                                                                </AuthEnty>
      <AuthEnty affiliation="AG2R AGIRC-ARRCO (UGRR)">
        <ExtLink title="SIREN" URI="775682917" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
        <ExtLink title="RNSR" URI="200711918R" role="labo id"/>
      </AuthEnty>
      <othId affiliation="J&#xE9;r&#xF4;me PALAZZOLO" type="contributor">
        <ExtLink title="ORCID" URI="0000-0002-6650-1169" role="team member id"/>
        <ExtLink title="IdRef" URI="061089842" role="team member id"/>
      </othId>
      <othId affiliation="UNIVERSITE CLAUDE BERNARD LYON 1" type="affiliation">
        <ExtLink title="SIREN" URI="196917744" role="organisation id"/>
        <ExtLink title="ROR" URI="https://ror.org/029brtt94" role="organisation id"/>
        <ExtLink title="RNSR" URI="200711918R" role="labo id"/>
      </othId>
      <othId affiliation="A network of digital health partners bringing together healthcare facilities, healthcare professionals, research teams, and organizations specializing in digital health technologies." type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            ASSOCIATION DES UTILISATEURS DE DOSSIERS INFORMATISES EN PEDIATRIE, OBSTETRIQUE ET GYNECOLOGIE (AUDIPOG)                                            <ExtLink title="SIREN" URI="398708537" role="sponsor id"/>
                    
                </producer>
      <producer role="sponsor">
                                            AEPEI (ASSOCIATION POUR L&amp;#039;ETUDE ET LA PREVENTION DES L&amp;#039;ENDOCARDITE INFECTIEUSE)                                            <ExtLink title="SIREN" URI="428445696" role="sponsor id"/>
                    
                </producer>
      <prodPlac>
                France Recherche en Santé Humaine (FReSH)            </prodPlac>
      <fundAg>
                                            AGENCE DE L ENVIRONNEMENT ET DE LA MAITRISE DE L ENERGIE (ADEME)                                            <ExtLink title="SIREN" URI="385290309"/>
                                    </fundAg>
      <fundAg>
                                            ASS RECHERCHE EPIDEMIOLOGIQUE REGISTRES (ARER68)                                            <ExtLink title="SIREN" URI="352113096"/>
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="UNIVERSITE CLAUDE BERNARD LYON 1" email="test@impactgroup.tech">
                    Jérôme;PALAZZOLO
                                            <ExtLink title="SIREN" URI="196917744" role="organisation id"/>
                                            <ExtLink title="ROR" URI="https://ror.org/029brtt94" role="organisation id"/>
                                            <ExtLink title="RNSR" URI="200711918R" role="labo id"/>
                                    </contact>
      <contact affiliation="AG2R AGIRC-ARRCO (UGRR)" email="walma.gharbi@impactgroup.tech">
                    Walma;Gharbi
                                            <ExtLink title="SIREN" URI="775682917" role="organisation id"/>
                                            <ExtLink title="RNSR" URI="200711918R" role="labo id"/>
                                    </contact>
      <depDate date="2026-09-23"/>
      <distDate date="2026-09-23"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <studyAuthorization>
    <authorizingAgency>ANSM                </authorizingAgency>
    <authorizingAgency>CESREES                </authorizingAgency>
  </studyAuthorization>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    digital health</keyword>
      <keyword vocab="" vocabURI="">
                    remote monitoring</keyword>
      <keyword vocab="" vocabURI="">
                    apa</keyword>
      <keyword vocab="" vocabURI="">
                    chronic diseases</keyword>
      <topcClas vocab="health theme">
                        Addiction medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/42d645e0-f58d-40ed-9917-5b227ff41a92"/>
                                                            <ExtLink title="MeSH" URI="D000073316"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Chronic                                            </topcClas>
      <topcClas vocab="health determinant">
                        Environmental determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">null</abstract>
    <abstract contentType="abstract">This study evaluates the use of a digital platform that enables patients with chronic conditions to receive remote support for adapted physical activity. The platform allows users to schedule sessions, track physical activity, communicate with healthcare professionals, and enter data related to their health status. The study aims to measure the impact of this system on participants’ physical activity levels, program adherence, and quality of life.</abstract>
    <sumDscr>
      <collDate event="start" date="2026-03-01"/>
      <collDate event="end" date="2027-02-28"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Auvergne Rhône-Alpes</geogCover>
      <geogCover>Bourgogne Franche-Comté</geogCover>
      <geogUnit/>
      <anlyUnit>
                Individus            </anlyUnit>
      <universe level="type" clusion="I">General population                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="D005260"/>
                                                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Other                                                            <concept vocab="MeSH"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="D000369"/>
                                                    </universe>
      <universe clusion="I">Patients aged 18 or older; with a chronic condition compatible with participating in adapted physical activity; who have a prescription or recommendation for adapted physical activity when required; who have access to equipment that allows them to use the digital platform; and who have given their consent to participate in the study.                    </universe>
      <universe clusion="E">Medical contraindications to participating in adapted physical activity; inability to use the digital device; inability to follow the study procedures; refusal or withdrawal of consent; simultaneous participation in another study that could interfere with the results.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Paraclinical data (non-biological)</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <producer role="committee">The Scientific and Steering Committee is responsible for overseeing the study, validating scientific and methodological approaches, and monitoring data quality and utilization. It brings together representatives from research teams, healthcare professionals, and experts in digital health.                                </producer>
        </standard>
      </standardsCompliance>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>To evaluate the feasibility and acceptability of using a digital platform for remote monitoring of adapted physical activity in patients with chronic diseases, particularly with regard to platform usage, program adherence, and the completeness of the data collected.</description>
    </developmentActivity>
    <developmentActivity type="secondary evaluation">
      <description>To assess changes in participants&amp;#039; physical activity levels over the follow-up period.
To assess changes in participants&amp;#039; self-reported quality of life.
Assess participation in adapted physical activity sessions.
Assess the frequency and duration of use of the digital platform.
Identify the challenges faced by participants and professionals when using the system.
Assess participant and professional satisfaction with the digital platform.</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <frequenc>Data were collected at enrollment and then daily via the medication-tracking app. Questionnaires were completed at enrollment, at the midpoint, and at the end of the study.</frequenc>
      <sampProc>Complete enumeration (including consecutive recruitment)                                                            <concept vocab="CESSDA" vocabURI="TotalUniverseCompleteEnumeration"/>
                                                    </sampProc>
      <sampProc>Probability                                                            <concept vocab="CESSDA" vocabURI="Probability"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Administrative database (employees</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>pupils</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>students</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Measurements and tests                                                            <concept vocab="CESSDA" vocabURI="MeasurementsAndTests"/>
                                                    </collMode>
      <collMode>Observation (clinical or behavioural)                                                            <concept vocab="CESSDA" vocabURI="Observation"/>
                                                    </collMode>
      <collMode>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </collMode>
      <sources>
        <sources>
          <sourceCitation>
            <titlStmt>
              <titl>A mobile app used by participants to report when they take their medication, receive reminders, and provide information on their adherence and satisfaction. Data are collected automatically or entered directly by participants throughout the study.</titl>
            </titlStmt>
            <holdings>SRC-COMPLIANCE-MOBILE-001</holdings>
            <notes subject="source purpose">
                                            Data enrichment through cross-referencing</notes>
          </sourceCitation>
          <srcOrig>Clinical source Clinical record</srcOrig>
        </sources>
      </sources>
    </dataColl>
    <notes>Interventional Study</notes>
    <notes subject="research type">
                        Interventional Study                    </notes>
    <notes subject="follow-up">
                        Monitoring by contact with the participant (mail, e-mail, telephone etc.)                    </notes>
    <anlyInfo>
      <respRate>180</respRate>
    </anlyInfo>
    <stdyClas>Ongoing study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <accsPlac>
                            The data is hosted on a secure infrastructure located in France or in the European Union, in accordance with applicable data protection and security requirements.                        </accsPlac>
      <avlStatus>
                            Open access                                                            <ExtLink title="COAR" URI="http://purl.org/coar/access_right/c_abf2"/>
                                                    </avlStatus>
      <complete>Data files are regularly checked for completeness. Missing data are identified and documented. The key variables used to monitor adherence are checked before each analysis.</complete>
      <notes>https://data.example.org/observance-mobile/data-access-plan</notes>
    </setAvail>
    <useStmt>
      <confDec>A confidentiality agreement may be required before any access to individual data or data that poses a risk of re-identification. Authorized users agree to comply with the applicable confidentiality and security rules.</confDec>
      <specPerm>https://data.example.org/observance-mobile/access-request</specPerm>
      <restrctn>Individual identifying data are not publicly accessible. Any Reuse</restrctn>
      <contact email="sophie.martin@example.org">Sophie;MARTIN</contact>
      <citReq>Any publication or communication that uses the data must cite the OBSERVANCE-MOBILE study and the dataset in accordance with the citation guidelines established by the study principal investigator.</citReq>
      <deposReq>Any scientific works, publications, or presentations resulting from the use of the data must be submitted to the principal investigator prior to their dissemination, in accordance with the defined access conditions.</deposReq>
      <conditions>Access to the data is restricted to authorized individuals working on scientific or research projects consistent with the study’s objectives. All requests for access are subject to approval by the study’s principal investigator.</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Terms and Conditions for the Provision of Aggregated Data</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
