Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-03-03 @ 10:06 AM
Study NCT ID:
NCT03327233
Status:
UNKNOWN
Last Update Posted:
2017-10-31
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CONNECARE-Assuta-Case Study 1
Sponsor:
Assuta Medical Center
Organization:
Study Overview
Official Title:
Integrated Personalized Connected Care for Complex Chronic Patients - Community-based Management
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
The intervention in this study consists of two parts:
1. Integrative treatment in the community, which includes a close follow-up with a coordinating nurse for three months after discharge from the hospital.
2. Empowering the patient to self-manage his or her health by using applications for smart devices.
The study protocol:
1. Recruitment of participants during the patient's hospitalization after the patient is identified as a complex patient, explanation of the study and signing the consent form.
2. Evaluation process for the patient, using valid questionnaires, in order to determine the baseline level at the entrance to the study.
3. Distribution of research kit and related accessories and training.
4. Close monitoring for three months in the community after discharge from the hospital and use of the research kit.
5. Reassessment of the patient at the exit of the study.
1. Integrative treatment in the community, which includes a close follow-up with a coordinating nurse for three months after discharge from the hospital.
2. Empowering the patient to self-manage his or her health by using applications for smart devices.
The study protocol:
1. Recruitment of participants during the patient's hospitalization after the patient is identified as a complex patient, explanation of the study and signing the consent form.
2. Evaluation process for the patient, using valid questionnaires, in order to determine the baseline level at the entrance to the study.
3. Distribution of research kit and related accessories and training.
4. Close monitoring for three months in the community after discharge from the hospital and use of the research kit.
5. Reassessment of the patient at the exit of the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: