Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

CONNECARE-Assuta-Case Study 1

26. oktober 2017 oppdatert av: Dr Bellaa Azria, Assuta Medical Center

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

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

220

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: Connecare 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.
Ingen inngripen: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital
Tidsramme: One month
Number of hospitalizations and emergency room visits after discharge
One month
Re-Hospitalizations and emergency room visits in the long term after discharge from the hospital
Tidsramme: One year
Number of hospitalizations and emergency room visits after discharge
One year
Length of hospitalization
Tidsramme: Less then one month
In days
Less then one month

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Compliance with the assignments in the discharge program guidelines
Tidsramme: One year
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
One year
Community health services use
Tidsramme: One year
Number of appointments made by the patient during the follow up time for primary physician, professionals, laboratory tests and imaging, physiotherapy and nutritionist.
One year
Evaluation of usability of the technology systems developed
Tidsramme: One year
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
One year
Cost-benefits evaluation for the intervention
Tidsramme: One year
Economic evaluation of tests and services saved as a result of active and orderly monitoring of the patient
One year
Assessment of satisfaction of patients from all the projects components (The follow up and the technology systems)
Tidsramme: One year
Using satisfaction questionnaires to be passed at the end of the study
One year
Assessment of satisfaction of medical staff from all the projects components (The follow up and the technology systems)
Tidsramme: One year
Using satisfaction questionnaires to be passed at the end of the study
One year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Assuta Medical Center

Samarbeidspartnere

European Commission

Etterforskere

  • Studieleder: Bella Azaria, Doctor, Assuta Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. februar 2018

Primær fullføring (Forventet)

1. februar 2019

Studiet fullført (Forventet)

1. februar 2019

Datoer for studieregistrering

Først innsendt

23. oktober 2017

Først innsendt som oppfylte QC-kriteriene

26. oktober 2017

Først lagt ut (Faktiske)

31. oktober 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. oktober 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. oktober 2017

Sist bekreftet

1. oktober 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 0033-17-ASMC

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Kronisk sykdom

Kliniske studier på Connecare self managment system

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Ireland

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere