CONNECARE-Assuta-Case Study 1

Not Applicable

• Conditions: Chronic Disease; Old Age; Debility
• Interventions: Device: Connecare self managment system

• Registration Number: NCT03327233
• Lead Sponsor: Assuta Medical Center

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 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.

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-26
• Last Update Submitted: 2017-10-26
• Study First Posted: 2017-10-31
• Last Update Posted: 2017-10-31
• Study Start: 2018-02-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• All Maccabi members who arrive at the ER in an unplanned manner

• Age over 65

• Living in a home and not in a nursing home

• LACE> 7

• At least three of the following conditions:

  • Multiple drugs - regular use of four or more drugs
  • More than one case of hospitalization or visit to the ER in the past year
  • Malnutrition
  • Elements of low socio-economic status

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Connecare self managment system	Implementing the Connecare system to support integrated care for complex patients with an unplanned admission to Assuta Ashdod who are discharged back to the community with an emphasis on Connecare self managment system for the patient and close follow up and coordination of all of the medical, health and social care in the community by a Maccabi integrated care nurse for a period of 3 months post discharge.

Primary Outcome Measures

Name	Time	Method
Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital	One month	Number of hospitalizations and emergency room visits after discharge
Length of hospitalization	Less then one month	In days
Re-Hospitalizations and emergency room visits in the long term after discharge from the hospital	One year	Number of hospitalizations and emergency room visits after discharge

Secondary Outcome Measures

Name	Time	Method
Assessment of satisfaction of patients from all the projects components (The follow up and the technology systems)	One year	Using satisfaction questionnaires to be passed at the end of the study
Cost-benefits evaluation for the intervention	One year	Economic evaluation of tests and services saved as a result of active and orderly monitoring of the patient
Evaluation of usability of the technology systems developed	One year	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
Assessment of satisfaction of medical staff from all the projects components (The follow up and the technology systems)	One year	Using satisfaction questionnaires to be passed at the end of the study
Compliance with the assignments in the discharge program guidelines	One year	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
Community health services use	One year	Number of appointments made by the patient during the follow up time for primary physician, professionals, laboratory tests and imaging, physiotherapy and nutritionist.