{"doc_desc":{"title":"Evaluation of the Effectiveness of a Digital Device for Remote Monitoring of Adapted Physical Activity in Patients with Chronic Diseases","idno":"FReSH-59394-en","producers":[{"name":"test SGsix","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FReSH-59394-en","IDno":{"metadata_no":[{"agency":"","code":""}],"metadata_yes":[{"code":"FReSH","agency":"FReSH"}]},"title":"Evaluation of the Effectiveness of a Digital Device for Remote Monitoring of Adapted Physical Activity in Patients with Chronic Diseases","alternate_title":"TELE-APA"},"study_authorization":{"agency":[{"name":"ANSM"},{"name":"CESREES"}]},"authoring_entity":[{"name":"Walma;Gharbi","firstname":"Walma","lastname":"Gharbi","type":"investigator","extlink":[{"title":"ORCID","uri":"0000-0002-1825-0097","role":"pi id"},{"title":"IdRef","uri":"061089842","role":"pi id"},{"title":"SIREN","uri":"775682917","role":"organisation id"},{"title":"RNSR","uri":"200711918R","role":"labo id"}],"email":"walma.gharbi@impactgroup.tech","affiliationName":"AG2R AGIRC-ARRCO (UGRR)","PILabo":"Department of Public Health and Digital Health","isContact":true}],"oth_id":[{"name":"J\u00e9r\u00f4me;PALAZZOLO","firstname":"J\u00e9r\u00f4me","lastname":"PALAZZOLO","type":"contributor","isContact":true,"extlink":[{"title":"ORCID","uri":"0000-0002-6650-1169","role":"team member id"},{"title":"IdRef","uri":"061089842","role":"team member id"}]},{"name":"UNIVERSITE CLAUDE BERNARD LYON 1","type":"affiliation","teamMemberLabo":"Digital Health and Public Health Research Team","extlink":[{"title":"SIREN","uri":"196917744","role":"organisation id"},{"title":"ROR","uri":"https:\/\/ror.org\/029brtt94","role":"organisation id"},{"title":"RNSR","uri":"200711918R","role":"labo id"}]},{"name":"A network of digital health partners bringing together healthcare facilities, healthcare professionals, research teams, and organizations specializing in digital health technologies.","type":"collaboration"}],"production_statement":{"prod_place":"France Recherche en Sant\u00e9 Humaine (FReSH)","producers":[{"name":"ASSOCIATION DES UTILISATEURS DE DOSSIERS INFORMATISES EN PEDIATRIE, OBSTETRIQUE ET GYNECOLOGIE (AUDIPOG)","role":"sponsor","extlink":[{"title":"SIREN","uri":"398708537","role":"sponsor id"}]},{"name":"AEPEI (ASSOCIATION POUR L'ETUDE ET LA PREVENTION DES L'ENDOCARDITE INFECTIEUSE)","role":"sponsor","extlink":[{"title":"SIREN","uri":"428445696","role":"sponsor id"}]}],"funding_agencies":[{"name":"AGENCE DE L ENVIRONNEMENT ET DE LA MAITRISE DE L ENERGIE (ADEME)","extlink":[{"title":"SIREN","uri":"385290309"}]},{"name":"ASS RECHERCHE EPIDEMIOLOGIQUE REGISTRES (ARER68)","extlink":[{"title":"SIREN","uri":"352113096"}]}]},"distribution_statement":{"contact":[{"name":"J\u00e9r\u00f4me;PALAZZOLO","lastname":"PALAZZOLO","firstname":"J\u00e9r\u00f4me","type":"contact","email":"test@impactgroup.tech","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","contactPointLabo":"Digital Health and Public Health Research Team","extlink":[{"title":"SIREN","uri":"196917744","role":"organisation id"},{"title":"ROR","uri":"https:\/\/ror.org\/029brtt94","role":"organisation id"},{"title":"RNSR","uri":"200711918R","role":"labo id"}]},{"name":"Walma;Gharbi","lastname":"Gharbi","firstname":"Walma","type":"contact","email":"walma.gharbi@impactgroup.tech","affiliationName":"AG2R AGIRC-ARRCO (UGRR)","contactPointLabo":"Department of Public Health and Digital Health","extlink":[{"title":"SIREN","uri":"775682917","role":"organisation id"},{"title":"RNSR","uri":"200711918R","role":"labo id"}]}]},"study_info":{"keywords":[{"keyword":"digital health"},{"keyword":"remote monitoring"},{"keyword":"apa"},{"keyword":"chronic diseases"}],"topics":[{"topic":"Addiction medicine","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/42d645e0-f58d-40ed-9917-5b227ff41a92"},{"title":"MeSH","uri":"D000073316"}],"vocab":"health theme"},{"topic":"Chronic","vocab":"cim-11","extLink":[{"title":"CIM-11","uri":"http:\/\/id.who.int\/icd\/entity\/490003542"}]},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"}],"purpose":"","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\u2019 physical activity levels, program adherence, and quality of life.","coll_dates":[{"start":"2026-03-01","end":"2027-02-28"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes','Bourgogne Franche-Comt\u00e9']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D005260\"\n            },\n            \"value\": \"Female\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D008297\"\n            },\n            \"value\": \"Male\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"\"\n            },\n            \"value\": \"Other\"\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000328\"\n            },\n            \"value\": \"Adult (25 to 44 years)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D008875\"\n            },\n            \"value\": \"Middle Aged (45 to 64 years)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000368\"\n            },\n            \"value\": \"Aged (65 to 79 years)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000369\"\n            },\n            \"value\": \"Aged, 80 and over (80 years and more)\"\n        }\n    ],\n    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"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.\",\n    \"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.\"\n}","data_kind":"['Clinical data','Paraclinical data (non-biological)']","quality_statement":{"standards":[{"name":"","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.","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_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."},{"activity_type":"secondary evaluation","activity_description":"To assess changes in participants' physical activity levels over the follow-up period.\r\nTo assess changes in participants' self-reported quality of life.\r\nAssess participation in adapted physical activity sessions.\r\nAssess the frequency and duration of use of the digital platform.\r\nIdentify the challenges faced by participants and professionals when using the system.\r\nAssess participant and professional satisfaction with the digital platform."}]},"method":{"data_collection":{"time_method":"","frequency":"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.","sampling_procedure":"['{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"TotalUniverseCompleteEnumeration\"},\"value\":\"Complete enumeration (including consecutive recruitment)\"}','{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"Probability\"},\"value\":\"Probability\"}']","sample_frame":{"frame_unit":{"unit_type":"['Administrative database (employees, pupils, students, etc.)']"}},"coll_mode":["{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"MeasurementsAndTests\"},\"value\":\"Measurements and tests\"}","{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"Observation\"},\"value\":\"Observation (clinical or behavioural)\"}","{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"Other\"},\"value\":\"Other\"}"],"research_instrument":"Terms and Conditions for the Provision of Aggregated Data","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."},"holdings":"SRC-COMPLIANCE-MOBILE-001","notes":{"subject":"source purpose","value":"Data enrichment through cross-referencing"}},"srcOrig":["Clinical source Clinical record"]}],"target_sample_size":"< 500 individuals","response_rate":"180"},"method_notes":"Interventional Study","study_class":"Ongoing study","notes":[{"subject":"research type","values":["Interventional Study"]},{"subject":"follow-up","values":["Monitoring by contact with the participant (mail, e-mail, telephone etc.)"]}]},"data_access":{"dataset_availability":{"access_place":"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.","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.","status":"{\"extLink\":{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_abf2\"},\"value\":\"Open access\"}","notes":"https:\/\/data.example.org\/observance-mobile\/data-access-plan"},"dataset_use":{"restrictions":"Individual identifying data are not publicly accessible. Any Reuse","conditions":"Access to the data is restricted to authorized individuals working on scientific or research projects consistent with the study\u2019s objectives. All requests for access are subject to approval by the study\u2019s principal investigator.","conf_dec":[{"txt":"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."}],"spec_perm":[{"txt":"https:\/\/data.example.org\/observance-mobile\/access-request","required":"Yes"}],"contact":[{"name":"Sophie;MARTIN","firstname":"Sophie","lastname":"MARTIN","email":"sophie.martin@example.org"}],"deposit_req":"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.","cit_req":"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."}}},"additional":{"versionLang":"en","originLang":"en","lastUpdatedAuto":"13-09-2026","lastUpdatedManual":"13-09-2026","autoTranslation":false,"status":"Published","respValidation":"","isHealthTheme":true,"isContributorPI":true,"addTeamMember":true,"primaryInvestigator":{"isPIContact":true,"piMail":"walma.gharbi@impactgroup.tech","piAffiliation":{"piLabo":"Department of Public Health and Digital Health"}},"relatedDocument":[],"contactPointLabo":"Department of Public Health and Digital Health","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"regulatoryRequirements":{"conformityDeclaration":"MR-001"},"fundingAgent":{"fundingAgentType":["Public (France)","Private non-profit"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Private non-profit","Private non-profit"],"otherSponsorType":["",""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":false},"interventionalStudy":{"researchPurpose":["Treatment"],"trialPhase":["Phase 1"],"interventionalStudyModel":"Single Group","isClinicalTrial":true,"otherResearchPurpose":""},"isInclusionGroups":false,"allocation":{"allocationMode":"Randomised","allocationUnit":"Individual"},"masking":{"maskingType":"Open label","blindedMaskingDetails":["Participant"]},"arms":[{"name":"Using the T\u00c9L\u00c9-APA Platform","type":"Experimental","typeOther":"","description":"Participants use the T\u00c9L\u00c9-APA digital platform during the follow-up period. The platform allows them to track their adapted physical activity, view their sessions, enter follow-up information, and communicate with the professionals involved in their care."},{"name":"Group using the mobile app","type":"Experimental","typeOther":"","description":"Participants use a mobile app designed to improve their adherence to treatment. The app allows them to receive medication reminders, report doses taken, and view their treatment history throughout the study."}],"intervention":[{"name":"Use of a Digital Platform for Remote Monitoring of Adapted Physical Activity","type":"Public Health","typeOther":""}],"cohortLongitudinal":{"recrutementTiming":[]},"otherResearchType":{"otherResearchTypeDetails":""},"inclusionGroups":[],"nrInclusionGroups":false,"collectionProcess":{"collectionModeDetails":"Data are collected at enrollment and during follow-up from questionnaires completed by participants and data generated by the mobile app. The app records participants\u2019 reports of medication intake, reminders received, and doses taken. Questionnaires are also used to assess adherence, satisfaction, and user experience.","collectionModeOther":"Alternative collection method: details\r\n"},"dataCollection":{"inclusionStrategy":[],"samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":"Documentation"},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"dataCollectionIntegration":{"isDataIntegration":true},"geographicalCoverage":{"geoDetail":"A multicenter study conducted with participants recruited from various healthcare facilities and in collaboration with partner healthcare professionals located in France. Follow-up can be conducted remotely via the digital platform."},"dataTypes":{"clinicalDataDetails":"Clinical Data, Details\r\n","biologicalDataDetails":"","biobankContent":[],"biobankContentOther":"","dataTypeOther":"","paraclinicalDataOther":"","otherLiquidsDetails":""},"variableDictionnary":{"variableDictionnaryAvailable":true,"variableDictionnaryLink":"www.acces.com"},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":true,"mockSampleLocation":"www.lien.com"},"thirdPartySource":{"otherSourceType":[""]},"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[{"type":"Other","uri":"DATA-OBSERVANCE-2026-001"}]}}}}},"schematype":"survey"}