New Care Pathways for Supporting TRANSitional CARE From Hospital to Home Using AI and Personalized Digital Assistance (TRANSCARE)
23. juli 2026 opdateret af: Istituto Nazionale di Ricovero e Cura per Anziani
The objective of the TRANSCARE study is to evaluate the use of a digital remote monitoring system to reduce the risk of 30-day readmission in multimorbid elderly patients.
The pilot study is multicenter, and the trial will be conducted across 3 sites: Italy, Romania, and Norway.
The overall goal of the TRANSCARE project is to create a digital monitoring ecosystem capable of identifying and preventing the risk of readmission.
Two hundred and ten older adults aged over 65, who meet the inclusion and exclusion criteria, will be enrolled in the study.
They will be randomized into two groups and allocated to an intervention group or a control group.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
210
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Anna Rita Bonfigli, PhD
- Telefonnummer: 0718003719
- E-mail: a.bonfigli@inrca.it
Studiesteder
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Ancona, Italien, 60127
- Rekruttering
- IRCCS INRCA Hospital
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Kontakt:
- Antonio Cherubini, Prof. MD
- Telefonnummer: +390718003537
- E-mail: a.cherubini@inrca.it
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Ledende efterforsker:
- Antonio Cherubini, Prof. Dr.
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Farsund, Norge
- Rekruttering
- Farsund Kommune
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Cluj-Napoca, Rumænien
- Rekruttering
- Institutul Inimii "Niculae Stăncioiu"
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Kontakt:
- Ovidiu Anchidin, M.D., Ph.D.
- Telefonnummer: +40 264 591 941
- E-mail: anchidin_ovidiu@institutulinimii.ro
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Able to stand and walk even with support;
- Mini Mental State Examination (MMSE) ≥ 18;
- Clinical Frailty Scale (CFS) score 2-7;
Exclusion Criteria:
- Allergy to nichel components;
- Concomitant participation in other studies;
- Severe dementia condition
- Mild to moderate dementia condition in the absence of the caregiver
- Terminal chronic renal failure with the need for dialysis
- Inability or unwillingness to sign written informed consent;
- Pacemaker or implantable cardioverter defibrillator;
- Metastatic cancer or immunosuppressive therapy;
- Significant visual or hearing impairment;
- Severe systemic diseases with life expectancy < 6 year;
- Move to nursing home after discharge
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: TRANSCARE Ecosystem Group
Participants in this arm will receive the TRANSCARE digital remote monitoring ecosystem upon hospital discharge for a duration of 90 days.
This includes a suite of home medical monitoring devices (for measuring physiological vital signs) and a wearable activity tracking device connected to a central digital platform.
Participants will use these tools for daily health self-monitoring to enable early risk detection and promote self-management capabilities.
In addition to the technological intervention, participants will receive standard post-discharge care.
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A digital remote monitoring suite comprising connected home medical devices for physiological parameter measurement, a wearable activity tracker, and an integrated telemonitoring software platform designed for patient self-management and clinical risk detection.
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Ingen indgriben: Usual Care Group
Participants in this arm will receive standard post-discharge care (usual care) provided by the national healthcare system without the TRANSCARE digital monitoring tools or wearable devices.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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30-Day Re-hospitalization Rate
Tidsramme: 30 days post-discharge
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Percentage of participants re-admitted to the hospital for any all-cause unplanned readmission within 30 days following discharge.
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30 days post-discharge
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Re-hospitalization Rate at 60 days
Tidsramme: 60 days post-discharge
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Percentage of participants with all-cause unplanned hospital readmissions evaluated at 60 days post-discharge.
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60 days post-discharge
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Re-hospitalization Rate at 90 Days
Tidsramme: 90 days post-discharge
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Percentage of participants with all-cause unplanned hospital readmissions evaluated at 90 days post-discharge
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90 days post-discharge
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Change in Physical Performance
Tidsramme: Baseline, 30 days, 60 days, and 90 days post-discharge.
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Assessment of physical performance using the Short Physical Performance Battery (SPPB) score (range 0-12, where higher scores indicate better physical function).
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Baseline, 30 days, 60 days, and 90 days post-discharge.
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Platform Usability
Tidsramme: 30 days, 60 days, and 90 days post-discharge
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Usability of the digital monitoring ecosystem evaluated using the System Usability Scale (SUS) (score 0-100)
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30 days, 60 days, and 90 days post-discharge
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Psychosocial Impact of Technology
Tidsramme: 30 days, 60 days, and 90 days post-discharge
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The perceived impact evaluated through the Psychosocial Impact of Assistive Devices Scale (PIADS)
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30 days, 60 days, and 90 days post-discharge
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Change in Digital Health Literacy
Tidsramme: Baseline and 90 days post-discharge
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Evaluation of digital health literacy skills measured using the eHealth Literacy Scale (eHEALS) (score 8-40, higher scores indicate higher perceived eHealth literacy).
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Baseline and 90 days post-discharge
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Ionut Anghel, Prof. Dr., Technical University of Cluj-Napoca, Romania
- Ledende efterforsker: Roberta Bevilacqua, Ph.D., IRCCS INRCA, Ancona, Italy
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. december 2025
Primær færdiggørelse (Anslået)
28. februar 2027
Studieafslutning (Anslået)
28. februar 2027
Datoer for studieregistrering
Først indsendt
23. juli 2026
Først indsendt, der opfyldte QC-kriterier
23. juli 2026
Først opslået (Faktiske)
28. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- INRCA_004_2026
- THCS-1449 (Andet bevillings-/finansieringsnummer: Transforming Health and Care Systems (THCS) / European Union Horizon Europe)
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