- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02851225
Coordinate Regulation of Transfusions by Uploading (RTT)
Currently in the Toulouse University Hospital, the organization of transfusion care for patients requiring regular transfusions is based on reading the biological results received by fax before confirming or disproving a planned hospitalization or program a new hospital if needed.
Remote transmission of laboratory results, replacing fax communication might facilitate the coordination of care that results from these laboratory results and provide a better respect of the Plan Custom Care Transfusion (PPST).
The investigators offer organization of transfusion supportive care for patients with conditions requiring biological monitoring using the techniques of information and communication telemedicine.
Primary objective
- Assess the feasibility of setting up an upload procedure biological results in the treatment of transfusion supportive care.
Secondary objectives
- Assess the evolution of the quality of life of patients during the treatment
- Assess changes in patient satisfaction over the support
- Assess the evolution of the satisfaction of the medical team at home and at Toulouse University Hospital
- Describe the programming time (hospitalization, consultations)
- Estimate the loss of biological results
- Assessment of the descriptive use of hospitalization, consultation and biological examinations in both groups. This remedy shall be valued in Euros thanks to GHS rates for hospitalizations, general nomenclature for Professional acts (NGAP) and biology nomenclature (NABM) for biological tests.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Setting up a Custom Care Plan for patients with conditions requiring a transfusion followed , which in its development provides a transfusion Care Custom Program .
The establishment of an electronic transmission enables the regulation of all hospitalizations throughout the patient care pathway and reinforces the link city / hospital through the receipt of laboratory results and issuing information to the partners of the care network patient. The PPST will be transmitted by secure messaging.
The primary endpoint is the proportion of transfusion episodes where PPST is respected. The proportion of patients whose care meets the PPST for 3 successive transfusion episodes will also be estimated.
The secondary endpoints are:
- The Patient satisfaction questionnaires (relative to the consideration of the results, the management procedures) in 3 successive transfusions.
- The Quality of life of the patient assessed by questionnaire (EORTC-QLQC30 and EQ5D) at baseline and after 3 successive transfusion episodes.
- The Satisfaction surveys of the medical team at home and the service effector transfusion at baseline and after 3 successive transfusion episodes.
- The Response time for a hospitalization or consultation program on the study period.
- The Number of lost biological results.
- Evaluation of the descriptive use of hospitalization, consultation, biology.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Toulouse, France, 31059
- IUCT-O
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients receiving blood transfusions and / or platelet on our hospital
- Patient agreeing to participate in the project
Exclusion Criteria:
- A patient who can not fill questionaries.
- Absence of social coverage .
- Patient under guardianship or trusteeship safeguard justice
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: telemedicine transmission
telemedicine transmission of biological results in the treatment of transfusion supportive care
|
telemedicine transmission of biological informations
|
Aucune intervention: without telemedicine transmission
no telemedicine transmission of biological results in treatment in the treatment of transfusion supportive care
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Proportion of transfusion episodes in the Plan Custom Care Transfusion
Délai: 12 months
|
The primary endpoint chosen is the proportion of transfusion episodes where the Plan Custom Care Transfusion is respected. The element determining compliance will be: - Transfusion with remote transmission, and transfusion in a service defined in the Plan Custom Care Transfusion and transfusion with achievement of target hemoglobin levels |
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Quality of life of patients
Délai: 12 months
|
Assess the evolution of the quality of life of patients ( EORTC- QLQC30 questionnaires and EQ5D )
|
12 months
|
Patients satisfaction
Délai: 12 months
|
Assess changes in patient satisfaction ( satisfaction survey compared to the overall care , the inclusion of the results, the management procedures )
|
12 months
|
Satisfaction of medical team
Délai: 12 months
|
Assess the evolution of the satisfaction of the medical team at home and in Hospital ( satisfaction surveys )
|
12 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Odile Beyne Rauzy, MD, University Hospital, Toulouse
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Estimation)
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
Autres numéros d'identification d'étude
- 12 559 15
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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Essais cliniques sur telemedicine transmission of biological results
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Shanghai Institute Of Biological ProductsComplété