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NCT07731126

Overview

NCT ID: NCT07731126
Lead Sponsor: Istituto Nazionale di Ricovero e Cura per AnzianiOTHER
Official Title: New Care Pathways for Supporting TRANSitional CARE From Hospital to Home Using AI and Personalized Digital Assistance
Brief Summary: 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.
Conditions: Transitional Care
Remote Patient Monitoring (RPM)

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Dec 12, 2025Actual
Primary Completion Date: Feb 28, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 210Estimated
Primary Purpose: Health Services Research
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Anna Rita Bonfigli, PhDContact
a.bonfigli@inrca.it0718003719

Similar Studies

Participant Group/Arms

TRANSCARE Ecosystem GroupExperimental

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.

Other: TRANSCARE Digital Remote Monitoring Ecosystem

Usual Care GroupNo Intervention

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.