Chronic DiseaseNCT03327246
CONNECARE-Assuta-Case Study 2
A study testing Connecare self managment system in people with Chronic Disease and Old Age; Debility, run by Assuta Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Disease, Old Age; Debility
- What is being tested?
- Connecare self managment system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2018to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- Patients with cognitive or dementia problems
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Integrated Personalized Connected Care and Preventive Patient-centred Intervention for Complex Chronic Patients Undergoing Elective Major Surgical Procedures
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 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.
- Conditions
- Chronic Disease, Old Age; Debility
- Being tested
- Connecare self managment system
- Medical subject headings
- Chronic Disease, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connecare self managment systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Device: Connecare self managment system |
| No Intervention: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospitalization after surgery and complications during and after hospitalization
Measured: Less then one month
Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital
Number of hospitalizations and emergency room visits after discharge
Measured: 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
Measured: One year
Length of hospitalization
In days
Measured: Less then one month
Secondary outcomes (6)
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
Measured: One year
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.
Measured: One year
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
Measured: One year
Cost-benefits evaluation for the intervention
Economic evaluation of tests and services saved as a result of active and orderly monitoring of the patient
Measured: One year
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
Measured: One year
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Feb 2018 (estimated)
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Matched intervention - control group study
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Dr Bellaa Azria, Assuta Medical Center
- Investigators
- Bella Azaria, Doctor, Study director, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327246
- Sponsor's protocol ID
- 0036-17-ASMC
- Status last verified
- Oct 2017
- First submitted
- 23 Oct 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Personalized Connected Care and Preventive Patient-centred Intervention for Complex Chronic Patients Undergoing Elective Major Surgical Procedures
- ClinicalTrials.gov ID
- NCT03327246
- Acronym / sponsor ID
- 0036-17-ASMC
- Conditions
- Chronic Disease, Old Age; Debility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Matched intervention - control group study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Connecare self managment systemImplementing 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. |
| No Intervention: 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with cognitive or dementia problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connecare self managment systemThe 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. | Device | Intervention group |
Primary outcome
Length of hospitalization after surgery and complications during and after hospitalization
Time frame: Less then one month
Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital
Time frame: One month
Number of hospitalizations and emergency room visits after discharge
Re-Hospitalizations and emergency room visits in the long term after discharge from the hospital
Time frame: One year
Number of hospitalizations and emergency room visits after discharge
Length of hospitalization
Time frame: Less then one month
In days
6 secondary outcomes
Compliance with the assignments in the discharge program guidelines
Time frame: One year
Community health services use
Time frame: One year
Evaluation of usability of the technology systems developed
Time frame: One year
Cost-benefits evaluation for the intervention
Time frame: One year
Assessment of satisfaction of patients from all the projects components (The follow up and the technology systems)
Time frame: One year
Assessment of satisfaction of medical staff from all the projects components (The follow up and the technology systems)
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- The European Union's Horizon 2020 Call for ActionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bella Azaria, Doctor study director
Assuta Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Connecare self managment system in people with Chronic Disease and Old Age; Debility, run by Assuta Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reut Ron, M.SC (+972-542240225, Reutro@assuta.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospitalization after surgery and complications during and after hospitalization (time frame: Less then one month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.