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CONNECARE-Assuta-Case Study 1

Integrated Personalized Connected Care for Complex Chronic Patients - Community-based Management

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03327233
Enrollment
220
Registered
2017-10-31
Start date
2018-02-01
Completion date
2019-02-01
Last updated
2017-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease, Old Age; Debility

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.

Interventions

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.

Sponsors

European Commission
CollaboratorOTHER
Assuta Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Matched intervention - control group study

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Re-Hospitalizations and emergency room visits in the short term after discharge from the hospitalOne monthNumber of hospitalizations and emergency room visits after discharge
Re-Hospitalizations and emergency room visits in the long term after discharge from the hospitalOne yearNumber of hospitalizations and emergency room visits after discharge
Length of hospitalizationLess then one monthIn days

Secondary

MeasureTime frameDescription
Cost-benefits evaluation for the interventionOne yearEconomic evaluation of tests and services saved as a result of active and orderly monitoring of the patient
Compliance with the assignments in the discharge program guidelinesOne yearAt 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
Assessment of satisfaction of medical staff from all the projects components (The follow up and the technology systems)One yearUsing satisfaction questionnaires to be passed at the end of the study
Assessment of satisfaction of patients from all the projects components (The follow up and the technology systems)One yearUsing satisfaction questionnaires to be passed at the end of the study
Community health services useOne yearNumber of appointments made by the patient during the follow up time for primary physician, professionals, laboratory tests and imaging, physiotherapy and nutritionist.
Evaluation of usability of the technology systems developedOne yearUsing 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

Contacts

Primary ContactReut Ron, M.SC
Reutro@assuta.co.il+972-542240225

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026