FReSH-59394-en
Evaluation of the Effectiveness of a Digital Device for Remote Monitoring of Adapted Physical Activity in Patients with Chronic Diseases
TELE-APA
| Name | Country code |
|---|---|
| France | fr |
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.
['Clinical data','Paraclinical data (non-biological)']
Individus
| Topic | Vocabulary |
|---|---|
| Addiction medicine | health theme |
| Chronic | cim-11 |
| Environmental determinants | health determinant |
| Behavioral determinants | health determinant |
['Auvergne Rhône-Alpes','Bourgogne Franche-Comté']
{
"level_sex_clusion_I": [
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D005260"
},
"value": "Female"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D008297"
},
"value": "Male"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": ""
},
"value": "Other"
}
],
"level_age_clusion_I": [
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D000328"
},
"value": "Adult (25 to 44 years)"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D008875"
},
"value": "Middle Aged (45 to 64 years)"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D000368"
},
"value": "Aged (65 to 79 years)"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D000369"
},
"value": "Aged, 80 and over (80 years and more)"
}
],
"level_type_clusion_I": "General population",
"level_type_clusion_other": "",
"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.",
"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."
}
| Name |
|---|
| Walma;Gharbi |
| Name | Role |
|---|---|
| ASSOCIATION DES UTILISATEURS DE DOSSIERS INFORMATISES EN PEDIATRIE, OBSTETRIQUE ET GYNECOLOGIE (AUDIPOG) | sponsor |
| AEPEI (ASSOCIATION POUR L'ETUDE ET LA PREVENTION DES L'ENDOCARDITE INFECTIEUSE) | sponsor |
| Name |
|---|
| AGENCE DE L ENVIRONNEMENT ET DE LA MAITRISE DE L ENERGIE (ADEME) |
| ASS RECHERCHE EPIDEMIOLOGIQUE REGISTRES (ARER68) |
| Name |
|---|
| Jérôme;PALAZZOLO |
| UNIVERSITE CLAUDE BERNARD LYON 1 |
| A network of digital health partners bringing together healthcare facilities, healthcare professionals, research teams, and organizations specializing in digital health technologies. |
| Agency name |
|---|
| ANSM |
| CESREES |
['Administrative database (employees, pupils, students, etc.)']
['{"concept":{"vocab":"CESSDA","vocabURI":"TotalUniverseCompleteEnumeration"},"value":"Complete enumeration (including consecutive recruitment)"}','{"concept":{"vocab":"CESSDA","vocabURI":"Probability"},"value":"Probability"}']
Terms and Conditions for the Provision of Aggregated Data
Interventional Study
| Start | End |
|---|---|
| 2026-03-01 | 2027-02-28 |
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.
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.
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.
| Name | |
|---|---|
| Sophie;MARTIN | sophie.martin@example.org |
| Confidentiality declaration text |
|---|
| 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. |
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.
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.
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.
{"extLink":{"title":"COAR","uri":"http://purl.org/coar/access_right/c_abf2"},"value":"Open access"}
| Indicate if special permissions are required to access a resource | Special permissions description |
|---|---|
| Yes | https://data.example.org/observance-mobile/access-request |
Individual identifying data are not publicly accessible. Any Reuse
| Name | |
|---|---|
| Jérôme;PALAZZOLO | test@impactgroup.tech |
| Walma;Gharbi | walma.gharbi@impactgroup.tech |
FReSH-59394-en
| Name |
|---|
| test SGsix |