New Care Pathways for Supporting TRANSitional CARE From Hospital to Home Using AI and Personalized Digital Assistance

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorIstituto Nazionale di Ricovero e Cura per Anziani

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to stand and walk even with support;

Mini Mental State Examination (MMSE) ≥ 18;

Clinical Frailty Scale (CFS) score 2-7;

Disqualifiers

Allergy to nichel components;

Concomitant participation in other studies;

Severe dementia condition

Mild to moderate dementia condition in the absence of the caregiver

Trial design

Design model

Parallel

Treatments tested in this trial

  • TRANSCARE Digital Remote Monitoring Ecosystem

    Other intervention

    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.

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: TRANSCARE Ecosystem GroupExperimental treatment 1 intervention
Group B: Usual Care GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

30-Day Re-hospitalization Rate

Percentage of participants re-admitted to the hospital for any all-cause unplanned readmission within 30 days following discharge.

Time frame
30 days post-discharge

Secondary outcomes

1

Re-hospitalization Rate at 60 days

Percentage of participants with all-cause unplanned hospital readmissions evaluated at 60 days post-discharge.

Time frame
60 days post-discharge
2

Re-hospitalization Rate at 90 Days

Percentage of participants with all-cause unplanned hospital readmissions evaluated at 90 days post-discharge

Time frame
90 days post-discharge
3

Change in Physical Performance

Assessment of physical performance using the Short Physical Performance Battery (SPPB) score (range 0-12, where higher scores indicate better physical function).

Time frame
Baseline, 30 days, 60 days, and 90 days post-discharge.
4

Platform Usability

Usability of the digital monitoring ecosystem evaluated using the System Usability Scale (SUS) (score 0-100)

Time frame
30 days, 60 days, and 90 days post-discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Nazionale di Ricovero e Cura per Anziani

Lead sponsor

Technical University of Cluj-Napoca, Romania

Collaborator

INSTITUTUL INIMII "NICOLAE STANCIOIU" CLUJ-NAPOCA, Romania

Collaborator

Tellu AS, Norway

Collaborator

Farsund Kommune, Norway

Collaborator

Karde AS, Norway

Collaborator