ClinicalTrials.gg
Status unknownNCT03327233Updated Oct 31, 2017

CONNECARE-Assuta-Case Study 1

An interventional study of Connecare self managment system in Chronic Disease and Old Age; Debility, sponsored by Assuta Medical Center. Status unknown. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2017-10-31.

Sponsored by Assuta Medical Center · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Chronic Disease
  • Old Age; Debility
03

In context

Chronic Disease

1,004 studies on the registry are indexed under Chronic Disease; 174 are open to participants now.

This study's planned enrollment of 220 is above the median of 121 across 729 interventional studies indexed under Chronic Disease.

Browse Chronic Disease studies →

Lead sponsor

Assuta Medical Center is the lead sponsor of 43 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with cognitive or dementia problems
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (estimated)

Study arms

  • Experimental
    Intervention group

    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

  • No intervention
    Matched control group

    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

  • DeviceConnecare 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.

06

What researchers measure

Primary outcomes

  1. Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital

    Number of hospitalizations and emergency room visits after discharge

    Time frame: One month

  2. Re-Hospitalizations and emergency room visits in the long term after discharge from the hospital

    Number of hospitalizations and emergency room visits after discharge

    Time frame: One year

  3. Length of hospitalization

    In days

    Time frame: Less then one month

Secondary outcomes

  1. 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

    Time frame: One year

  2. 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.

    Time frame: One year

  3. 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

    Time frame: One year

  4. Cost-benefits evaluation for the intervention

    Economic evaluation of tests and services saved as a result of active and orderly monitoring of the patient

    Time frame: One year

  5. 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

    Time frame: One year

  6. 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

    Time frame: One year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03327233
Lead sponsor
Assuta Medical Center
Collaborators
European Commission
Responsible party
Dr Bellaa Azria (Head of Medicine, Assuta Medical Centers, Assuta Medical Center) — Principal investigator
First posted
Oct 31, 2017
Start date
Feb 1, 2018 (estimated)
Primary completion
Feb 1, 2019 (estimated)
Completion
Feb 1, 2019 (estimated)
Last update
Oct 31, 2017

Study contacts

Reut Ron, M.SC
Contact
Reutro@assuta.co.il
+972-542240225
Bella Azaria, Doctor
study director · Assuta Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion