Clinical trial NCT03327246: CONNECARE-Assuta-Case Study 2
Official title: Integrated Personalized Connected Care and Preventive Patient-centred Intervention for Complex Chronic Patients Undergoing Elective Major Surgical Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Old Age; Debility
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2017-10-31
Enrollment: 220
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Matched intervention - control group study
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of hospitalization after surgery and complications during and after hospitalization
timeFrame: Less then one month
measure: Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital
timeFrame: One month
measure: Re-Hospitalizations and emergency room visits in the long term after discharge from the hospital
timeFrame: One year
measure: Length of hospitalization
timeFrame: Less then one month
Secondary outcomes:
measure: Compliance with the assignments in the discharge program guidelines
timeFrame: One year
measure: Community health services use
timeFrame: One year
measure: Evaluation of usability of the technology systems developed
timeFrame: One year
measure: Cost-benefits evaluation for the intervention
timeFrame: One year
measure: Assessment of satisfaction of patients from all the projects components (The follow up and the technology systems)
timeFrame: One year
measure: Assessment of satisfaction of medical staff from all the projects components (The follow up and the technology systems)
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Assuta Medical Center
name: Bella Azaria, Doctor
role: STUDY_DIRECTOR
References: