NCT03327246

CONNECARE-Assuta-Case Study 2

Integrated Personalized Connected Care and Preventive Patient-centred Intervention for Complex Chronic Patients Undergoing Elective Major Surgical Procedures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Assuta Medical Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The intervention in this study consists of three parts: 1. Empowering the patient to self-manage his or her health by using applications for smart devices. 2. Intensive pre-habilitation plan with close monitoring during the month prior to surgery. 3. 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: 1. Recruitment of participants after scheduling a major elective surgery, 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 during pre habilitation plan for a month prior to surgery. 5. Reassessment of the patient after the surgery and before discharge from the hospital. 6. Close monitoring during three months in the community after discharge from the hospital and use of the research kit. 7. Reassessment of the patient at the exit of the study.

Conditions

• Chronic Disease
• Old Age; Debility

Interventions

Type	Name	Description
DEVICE	Connecare self managment system	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.

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2017-10-31
• Last updated: 2017-10-31