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 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.
The intervention in this study consists of three parts:
The study protocol:
781 studies on the registry are indexed under Chronic Disease; 144 are open to participants now.
This study's planned enrollment of 220 is above the median of 140 across 582 interventional studies indexed under Chronic Disease.
Browse Chronic Disease studies →Assuta Medical Center is the lead sponsor of 44 studies on the registry; 1 is open to participants now.
Compared within Chronic Disease, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Connecare self managment system
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
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.
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
Number of hospitalizations and emergency room visits after discharge
Time frame: 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
Time frame: One year
Length of hospitalization
In days
Time frame: Less then one month
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
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
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
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
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
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
No study locations are listed for this record.
Plan to share: No
Start is estimated for Feb 2018; primary completion for Feb 2019, 12 months later.
Of 318 non-industry interventional studies with no phase under Chronic Disease, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 33. This study's planned 12 months is below that.
Counting every sponsor, half of 328 studies reached it within 21 months; a quarter within 11 and three quarters within 33.
Chronic Disease covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Assuta Medical Center