CONNECARE-Assuta-Case Study 1

NCT03327233 | Unknown DMC

• 1 other identifier: 0033-17-ASMC
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Disease; Old Age; Debility

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Length of hospitalization

  In days

  Less then one month

Secondary Outcomes (6)

• Compliance with the assignments in the discharge program guidelines

  One year

• Community health services use

  One year

• Evaluation of usability of the technology systems developed

  One year

• Cost-benefits evaluation for the intervention

  One year

• Assessment of satisfaction of patients from all the projects components (The follow up and the technology systems)

  One year

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Device: Connecare self managment system

Matched control group

NO INTERVENTION

The control group will be selected from Maccabi's database and will be patients who are matched 1:1 with the intervention sample and live in another community similar to Ashdod in socioeconomic characteristics who undergo the same elective major surgery in other hospitals

Interventions

Connecare self managment system DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients with cognitive or dementia problems

Sponsors & Collaborators

• Assuta Medical Center: lead
• European Commission: collaborator

Related Links

• The European Union's Horizon 2020 Call for Action

MeSH Terms

Conditions

Chronic Disease; Frailty

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bella Azaria, Doctor

  Assuta Medical Center

  STUDY DIRECTOR

Central Study Contacts

Reut Ron, M.SC

CONTACT

+972-542240225; Reutro@assuta.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medicine, Assuta Medical Centers

Model Details: Matched intervention - control group study

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: October 31, 2017
• Study Start: February 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: October 31, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share