CONNECARE-Assuta-Case Study 2
26 octobre 2017 mis à jour par: Dr Bellaa Azria, Assuta Medical Center
Integrated Personalized Connected Care and Preventive Patient-centred Intervention for Complex Chronic Patients Undergoing Elective Major Surgical Procedures
The European Union's Horizon 2020 project issued a Call for Action [1] in December 2013 to design, develop, disseminate and evaluate new IT technologies for use in integrative treatment processes, with emphasis on complex adult patient. Assuta Hospital submitted a proposal for this call, as part of a broad consortium of 10 participants from various European countries.
The CONNECARE consortium has formulated a general model for integrative treatment, and is currently in the technological development stages, to create a smart (supportive decision) and adaptive system that supports integrative treatment processes both in the hospital and in the community for personalized treatment in complex chronic patients. The development includes a significant integrative component of self-care management by the patient and / or the primary caregiver.
Following the completion of the technological development, clinical trials will be held in four organizations throughout Europe - Assuta Hospital in Ashdod in cooperation with the Maccabi community in Ashdod, two centers in Catalonia and the Groningen region in the Netherlands. The purpose of the studies is to assess the impact of the implementation of the model, processes and digital tools that will be built during the project.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
The intervention in this study consists of three parts:
- Empowering the patient to self-manage his or her health by using applications for smart devices.
- Intensive pre-habilitation plan with close monitoring during the month prior to surgery.
- Integrative treatment in the community, which includes a close followup with a coordinating nurse for three months after discharge from the hospital.
The study protocol:
- Recruitment of participants after scheduling a major elective surgery, explanation of the study and signing the consent form.
- Evaluation process for the patient, using valid questionnaires, in order to determine the baseline level at the entrance to the study.
- Distribution of research kit and related accessories and training.
- Close monitoring during pre habilitation plan for a month prior to surgery.
- Reassessment of the patient after the surgery and before discharge from the hospital.
- Close monitoring during three months in the community after discharge from the hospital and use of the research kit.
- Reassessment of the patient at the exit of the study.
Type d'étude
Interventionnel
Inscription (Anticipé)
220
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- All Maccabi members who were scheduled for a major elective surgery
- Age over 65
- Living in a home and not in a nursing home
- Anesthesiologist ASA score evaluation of levels 2 or 3 only
- Diagnosis of at least one chronic disease of the following - COPD, cardiovascular disease, diabetes, hypertension, cancer or obesity.
- The patient and / or the main caregiver speak Hebrew, English or Russian
- The patient or primary caregiver has a password to the Maccabi Online website
- The patient and / or the primary caregiver have basic technological knowledge in the use of the applications
- The patient has wireless Internet access at home (via Wifi or through a cellular connection)
Exclusion Criteria:
- Patients with cognitive or dementia problems
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention group
Implementing the Connecare system to support integrated care for complex patients who are plan to undergo a major elective surgery in Assuta Ashdod and are discharged back to the community with an emphasis on Connecare self managment system for the patient and close follow up and coordination of all of the medical, health and social care in the community for two periods of time: (1) Pre habilitation plan for a month prior to surgery (2) a period of 3 months post discharge.
|
The CONNECARE SMS will rely on a hybrid solution that, besides being autonomous (the patient may use the SMS to monitor and access to her/his data and information), has also a collaborative component (through the interaction with the SACM) to allow participation by clinicians and to provide feedback to them.
In so doing, the patient may control her/his activity, receiving recommendations to improve the treatment and to be encouraged in following it.
|
|
Aucune intervention: No Intervention: Matched control group
The control group will be selected from Maccabi's database and will be patients who are matched 1:1 with the intervention sample and live in another community similar to Ashdod in socioeconomic characteristics who undergo the same elective major surgery in other hospitals
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital
Délai: One month
|
Number of hospitalizations and emergency room visits after discharge
|
One month
|
|
Re-Hospitalizations and emergency room visits in the long term after discharge from the hospital
Délai: One year
|
Number of hospitalizations and emergency room visits after discharge
|
One year
|
|
Length of hospitalization
Délai: Less then one month
|
In days
|
Less then one month
|
|
Length of hospitalization after surgery and complications during and after hospitalization
Délai: Less then one month
|
Less then one month
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Compliance with the assignments in the discharge program guidelines
Délai: One year
|
At the time of discharge from the hospital, the patient receives a list of tasks to be performed as part of the release letter.
We would like to know how many out of this tasks were carried out
|
One year
|
|
Community health services use
Délai: One year
|
Number of appointments made by the patient during the follow up time for primary physician, professionals, laboratory tests and imaging, physiotherapy and nutritionist.
|
One year
|
|
Evaluation of usability of the technology systems developed
Délai: One year
|
Using questionnaires for nurses and patients to express their opinion on the use of the technology systems in the project and how much these systems assisted them
|
One year
|
|
Cost-benefits evaluation for the intervention
Délai: One year
|
Economic evaluation of tests and services saved as a result of active and orderly monitoring of the patient
|
One year
|
|
Assessment of satisfaction of patients from all the projects components (The follow up and the technology systems)
Délai: One year
|
Using satisfaction questionnaires to be passed at the end of the study
|
One year
|
|
Assessment of satisfaction of medical staff from all the projects components (The follow up and the technology systems)
Délai: One year
|
Using satisfaction questionnaires to be passed at the end of the study
|
One year
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Bella Azaria, Doctor, Assuta Medical Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 février 2018
Achèvement primaire (Anticipé)
1 février 2019
Achèvement de l'étude (Anticipé)
1 février 2019
Dates d'inscription aux études
Première soumission
23 octobre 2017
Première soumission répondant aux critères de contrôle qualité
26 octobre 2017
Première publication (Réel)
31 octobre 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
31 octobre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 octobre 2017
Dernière vérification
1 octobre 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 0036-17-ASMC
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .