CONNECARE-Assuta-Case Study 2

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03327246
• Other study ID #: 0036-17-ASMC
• Status: Not yet recruiting
• Phase: N/A
• First received: October 23, 2017
• Last updated: October 26, 2017
• Start date: February 1, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: October 2017
• Source: Assuta Medical Center
• Contact: Reut Ron, M.SC
• Phone: +972-542240225
• Email: Reutro[@]assuta.co.il
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Old Age; Debility

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assuta Medical Center	European Commission

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospitalization after surgery and complications during and after hospitalization		Less then one month
Primary	Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital	Number of hospitalizations and emergency room visits after discharge	One month
Primary	Re-Hospitalizations and emergency room visits in the long term after discharge from the hospital	Number of hospitalizations and emergency room visits after discharge	One year
Primary	Length of hospitalization	In days	Less then one month
Secondary	Compliance with the assignments in the discharge program guidelines	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
Secondary	Community health services use	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
Secondary	Evaluation of usability of the technology systems developed	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
Secondary	Cost-benefits evaluation for the intervention	Economic evaluation of tests and services saved as a result of active and orderly monitoring of the patient	One year
Secondary	Assessment of satisfaction of patients from all the projects components (The follow up and the technology systems)	Using satisfaction questionnaires to be passed at the end of the study	One year
Secondary	Assessment of satisfaction of medical staff from all the projects components (The follow up and the technology systems)	Using satisfaction questionnaires to be passed at the end of the study	One year

External Links

•   The European Union's Horizon 2020 Call for Action