CONNECARE-Assuta-Case Study 2

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03327246
Study type	Interventional
Source	Assuta Medical Center
Contact	Reut Ron, M.SC
Phone	+972-542240225
Email	Reutro@assuta.co.il
Status	Not yet recruiting
Phase	N/A
Start date	February 1, 2018
Completion date	February 1, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.