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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
TRANSCARE Digital Remote Monitoring Ecosystem
Other interventionA 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
Trial outcomes
Primary outcomes
30-Day Re-hospitalization Rate
Percentage of participants re-admitted to the hospital for any all-cause unplanned readmission within 30 days following discharge.
Secondary outcomes
Re-hospitalization Rate at 60 days
Percentage of participants with all-cause unplanned hospital readmissions evaluated at 60 days post-discharge.
Re-hospitalization Rate at 90 Days
Percentage of participants with all-cause unplanned hospital readmissions evaluated at 90 days post-discharge
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).
Platform Usability
Usability of the digital monitoring ecosystem evaluated using the System Usability Scale (SUS) (score 0-100)
Sponsors and contacts
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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