Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07731126

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Transitional Care Geriatric Multimorbidity Remote Patient Monitoring (RPM)

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS INRCA Hospital, Ancona, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRANSCARE Digital Remote Monitoring Ecosystem

Other

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.

Primary outcomes

  1. 30-Day Re-hospitalization Rate

    Time frame: 30 days post-discharge

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

Secondary outcomes

  1. Re-hospitalization Rate at 60 days

    Time frame: 60 days post-discharge

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

  2. Re-hospitalization Rate at 90 Days

    Time frame: 90 days post-discharge

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

  3. Change in Physical Performance

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

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

  4. Platform Usability

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

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

  5. Psychosocial Impact of Technology

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

    The perceived impact evaluated through the Psychosocial Impact of Assistive Devices Scale (PIADS)

  6. Change in Digital Health Literacy

    Time frame: Baseline and 90 days post-discharge

    Evaluation of digital health literacy skills measured using the eHealth Literacy Scale (eHEALS) (score 8-40, higher scores indicate higher perceived eHealth literacy).

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Rita Bonfigli, PhD

CONTACT

[email protected]

0718003719

Sponsors and collaborators

Lead sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Other

Collaborators

  • Farsund Kommune, Norway
  • INSTITUTUL INIMII "NICOLAE STANCIOIU" CLUJ-NAPOCA, Romania
  • Karde AS, Norway
  • Technical University of Cluj-Napoca, Romania
  • Tellu AS, Norway

Registry information

Acronym: TRANSCARE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.