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CONNECARE-Assuta-Case Study 2

Primary Purpose

Chronic Disease, Old Age; Debility

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Connecare self managment system
Sponsored by
Assuta Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    No Intervention: Matched control group

    Arm Description

    Implementing the Connecare system to support integrated care for complex patients who are plan to undergo a major elective surgery in Assuta Ashdod and 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 for two periods of time: (1) Pre habilitation plan for a month prior to surgery (2) a period of 3 months post discharge.

    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

    Outcomes

    Primary Outcome Measures

    Length of hospitalization after surgery and complications during and after hospitalization
    Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital
    Number of hospitalizations and emergency room visits after discharge
    Re-Hospitalizations and emergency room visits in the long term after discharge from the hospital
    Number of hospitalizations and emergency room visits after discharge
    Length of hospitalization
    In days

    Secondary Outcome Measures

    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
    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.
    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
    Cost-benefits evaluation for the intervention
    Economic evaluation of tests and services saved as a result of active and orderly monitoring of the patient
    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
    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

    Full Information

    First Posted
    October 23, 2017
    Last Updated
    October 26, 2017
    Sponsor
    Assuta Medical Center
    Collaborators
    European Commission
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03327246
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2018 (Anticipated)
    Primary Completion Date
    February 1, 2019 (Anticipated)
    Study Completion Date
    February 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assuta Medical Center
    Collaborators
    European Commission

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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: Empowering the patient to self-manage his or her health by using applications for smart devices. Intensive pre-habilitation plan with close monitoring during the month prior to surgery. 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: Recruitment of participants after scheduling a major elective surgery, explanation of the study and signing the consent form. Evaluation process for the patient, using valid questionnaires, in order to determine the baseline level at the entrance to the study. Distribution of research kit and related accessories and training. Close monitoring during pre habilitation plan for a month prior to surgery. Reassessment of the patient after the surgery and before discharge from the hospital. Close monitoring during three months in the community after discharge from the hospital and use of the research kit. Reassessment of the patient at the exit of the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Disease, Old Age; Debility

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Matched intervention - control group study
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    220 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Implementing the Connecare system to support integrated care for complex patients who are plan to undergo a major elective surgery in Assuta Ashdod and 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 for two periods of time: (1) Pre habilitation plan for a month prior to surgery (2) a period of 3 months post discharge.
    Arm Title
    No Intervention: Matched control group
    Arm Type
    No Intervention
    Arm Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    Connecare self managment system
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Length of hospitalization after surgery and complications during and after hospitalization
    Time Frame
    Less then one month
    Title
    Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital
    Description
    Number of hospitalizations and emergency room visits after discharge
    Time Frame
    One month
    Title
    Re-Hospitalizations and emergency room visits in the long term after discharge from the hospital
    Description
    Number of hospitalizations and emergency room visits after discharge
    Time Frame
    One year
    Title
    Length of hospitalization
    Description
    In days
    Time Frame
    Less then one month
    Secondary Outcome Measure Information:
    Title
    Compliance with the assignments in the discharge program guidelines
    Description
    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
    Title
    Community health services use
    Description
    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
    Title
    Evaluation of usability of the technology systems developed
    Description
    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
    Title
    Cost-benefits evaluation for the intervention
    Description
    Economic evaluation of tests and services saved as a result of active and orderly monitoring of the patient
    Time Frame
    One year
    Title
    Assessment of satisfaction of patients from all the projects components (The follow up and the technology systems)
    Description
    Using satisfaction questionnaires to be passed at the end of the study
    Time Frame
    One year
    Title
    Assessment of satisfaction of medical staff from all the projects components (The follow up and the technology systems)
    Description
    Using satisfaction questionnaires to be passed at the end of the study
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Reut Ron, M.SC
    Phone
    +972-542240225
    Email
    Reutro@assuta.co.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bella Azaria, Doctor
    Organizational Affiliation
    Assuta Medical Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://ec.europa.eu/research/participants/portal/desktop/en/opportunities/h2020/topics/phc-25-2015.html
    Description
    The European Union's Horizon 2020 Call for Action

    Learn more about this trial

    CONNECARE-Assuta-Case Study 2

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