- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02545374
Medico-economic Evaluation of a Project of Wounds by a Remote Network (DOMOPLAIES)
Medico-economic Evaluation of the DOMOPLAIES Project by the CICAT-LR Network
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Montpellier, France, 34295
- Wound healing Department
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
La description
Inclusion Criteria:
- Being adult
- Taken up residence on the Languedoc-Roussillon
- Patient carrying a wound with healing or improvement objective (wound closure or the appearance of 40% of granulation)
- Informed consent signed,
- Patient member of the Security Social
- Patient having a visiting nurse.
Exclusion Criteria:
- Patient in vital or functional emergency situation during the first call or during the consultation
- Tumoral wound
- dialysis patient
- Arteritis of stage 4 and not revascularizable
- Absence of regular doctor and visiting nurse
- patient refusal
- Refusal of one of the health professionals participating in the pathology care
- Anybody incapable to communicate and to answer the questions
- Pregnant or nursing woman
- Subject deprived of freedom by court or administrative order
- Major subject protected by the law
- For the patients in telemedicine: refusal of the collaboration agreement
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Telemedicine
In the telemedicine arm, all patients will be supported by Telemedicine protocol according to the development of telemedicine in the region. The use of teleconsultation allows the couple expert doctor / nurse expert to perform a complex of wound assessment consultation and / or chronic. The use of telemedicine allows for acts of telecare, when the nurse applicant sought a remote support of an expert nurse (under the responsibility of a doctor) for the realization of an act. The use of tele-expertise enables physicians to remotely bring special expertise to improve patient care. |
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Comparateur actif: Control
In the control arm, patient care depend on his home, as is currently the case:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Rate of healed chronic wounds during a telemedicine care
Délai: Six months after inclusion
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Rate of healed chronic wounds during a telemedicine care versus during a usual medical care
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Six months after inclusion
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Rate of healed chronic wounds during a usual medical care
Délai: Six months after inclusion
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Rate of healed chronic wounds during a telemedicine care versus during a usual medical care
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Six months after inclusion
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Result to the questionnaire on the quality of life: EQ-5D
Délai: Six months after inclusion
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Compare the quality of life of patients with chronic wounds during a telemedicine coverage versus during a usual medical care, thanks to the EQ-5D quality life scale.
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Six months after inclusion
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A measure of the costs of the management of the disease
Délai: Seven months after the inclusion of the last patient
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A measure of the costs of the management of the disease (consumer care, hospitalization, transport ...)
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Seven months after the inclusion of the last patient
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A measure of the costs of the intervention assessed
Délai: Seven months after the inclusion of the last patient
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A measure of the costs of the intervention assessed (investment, maintenance, training ...).
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Seven months after the inclusion of the last patient
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The total healing time
Délai: Six months after inclusion
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Six months after inclusion
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The decrease in centimeters of the wound surface to 6 months
Délai: Six months after inclusion
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Six months after inclusion
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The response time between making an appointment and support
Délai: Six months after inclusion
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Six months after inclusion
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The mortality rate within 6 months
Délai: Six months after inclusion
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Six months after inclusion
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 9250
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