NCT07731126

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2025

Geographic Reach
3 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Dec 2025Feb 2027

Study Start

First participant enrolled

December 12, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

July 23, 2026

Last Update Submit

July 23, 2026

Conditions

Transitional CareRemote Patient Monitoring (RPM)Geriatric Multimorbidity

Keywords

Digital Health EcosystemRemote Patient Monitoring (RPM)Multimorbidity30-Day Hospital ReadmissionSelf-Management EmpowermentOlder Adults / Geriatric CareMachine Learning Predictive ModelingeHealth LiteracyMulticenter Pilot Study

Outcome Measures

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.

    30 days post-discharge

Secondary Outcomes (6)

  • Re-hospitalization Rate at 60 days

    60 days post-discharge

  • Re-hospitalization Rate at 90 Days

    90 days post-discharge

  • Change in Physical Performance

    Baseline, 30 days, 60 days, and 90 days post-discharge.

  • Platform Usability

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

  • Psychosocial Impact of Technology

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

  • +1 more secondary outcomes

Study Arms (2)

TRANSCARE Ecosystem Group

EXPERIMENTAL

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 Group

NO 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.

Interventions

TRANSCARE Digital Remote Monitoring EcosystemOTHER

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.

TRANSCARE Ecosystem Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Able to stand and walk even with support;
  • Mini Mental State Examination (MMSE) ≥ 18;
  • Clinical Frailty Scale (CFS) score 2-7;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

IRCCS INRCA Hospital

Ancona, 60127, Italy

RECRUITING

Farsund Kommune

Farsund, Norway

RECRUITING

Institutul Inimii "Niculae Stăncioiu"

Cluj-Napoca, Romania

RECRUITING

Study Officials

  • Ionut Anghel, Prof. Dr.

    Technical University of Cluj-Napoca, Romania

    STUDY CHAIR

  • Roberta Bevilacqua, Ph.D.

    IRCCS INRCA, Ancona, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Rita Bonfigli, PhD

CONTACT

0718003719a.bonfigli@inrca.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 28, 2026

Study Start

December 12, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

July 28, 2026

Record last verified: 2026-07

Locations

IT(1)NO(1)RO(1)