Transitional CareTRANSCARENCT07731126
New Care Pathways for Supporting TRANSitional CARE From Hospital to Home Using AI and Personalized Digital Assistance
A study testing TRANSCARE Digital Remote Monitoring Ecosystem in people with Transitional Care and Remote Patient Monitoring (RPM), run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Transitional Care, Remote Patient Monitoring (RPM), Geriatric Multimorbidity
- What is being tested?
- TRANSCARE Digital Remote Monitoring Ecosystem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 12 Dec 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Able to stand and walk even with support;
- Mini Mental State Examination (MMSE) ≥ 18;
- Clinical Frailty Scale (CFS) score 2-7;
Who cannot join
- 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;
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Italy1 site, 1 recruiting
- Recruiting
IRCCS INRCA Hospital
Ancona, 60127
Antonio Cherubini, Prof. MD, +390718003537, a.cherubini@inrca.it
Antonio Cherubini, Prof. Dr.
Romania1 site, 1 recruiting
- Recruiting
Institutul Inimii "Niculae Stăncioiu"
Cluj-Napoca
Ovidiu Anchidin, M.D., Ph.D., +40 264 591 941, anchidin_ovidiu@institutulinimii.ro
About this study
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.
- Being tested
- TRANSCARE Digital Remote Monitoring Ecosystem
- Keywords
- Digital Health Ecosystem, Remote Patient Monitoring (RPM), Multimorbidity, 30-Day Hospital Readmission, Self-Management Empowerment, Older Adults / Geriatric Care, Machine Learning Predictive Modeling, eHealth Literacy, Multicenter Pilot Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day Re-hospitalization Rate
Percentage of participants re-admitted to the hospital for any all-cause unplanned readmission within 30 days following discharge.
Measured: 30 days post-discharge
Secondary outcomes (6)
Re-hospitalization Rate at 60 days
Percentage of participants with all-cause unplanned hospital readmissions evaluated at 60 days post-discharge.
Measured: 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
Measured: 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).
Measured: Baseline, 30 days, 60 days, and 90 days post-discharge.
Platform Usability
Usability of the digital monitoring ecosystem evaluated using the System Usability Scale (SUS) (score 0-100)
Measured: 30 days, 60 days, and 90 days post-discharge
Psychosocial Impact of Technology
The perceived impact evaluated through the Psychosocial Impact of Assistive Devices Scale (PIADS)
Measured: 30 days, 60 days, and 90 days post-discharge
Change in Digital Health Literacy
Evaluation of digital health literacy skills measured using the eHealth Literacy Scale (eHEALS) (score 8-40, higher scores indicate higher perceived eHealth literacy).
Measured: Baseline and 90 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start12 Dec 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transitional CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Cluj-Napoca, Romania, INSTITUTUL INIMII "NICOLAE STANCIOIU" CLUJ-NAPOCA, Romania, Tellu AS, Norway, Farsund Kommune, Norway, Karde AS, Norway
- Responsible party
- Sponsor
- Investigators
- Ionut Anghel, Prof. Dr., Study chair, Technical University of Cluj-Napoca, RomaniaRoberta Bevilacqua, Ph.D., Principal investigator, IRCCS INRCA, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731126
- Sponsor's protocol ID
- INRCA_004_2026
- Other IDs
- THCS-1449
- Acronym
- TRANSCARE
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Care Pathways for Supporting TRANSitional CARE From Hospital to Home Using AI and Personalized Digital Assistance
- ClinicalTrials.gov ID
- NCT07731126
- Acronym / sponsor ID
- TRANSCARE / INRCA_004_2026
- Keywords
- Digital Health Ecosystem, Remote Patient Monitoring (RPM), Multimorbidity, 30-Day Hospital Readmission, Self-Management Empowerment, Older Adults / Geriatric Care, Machine Learning Predictive Modeling, eHealth Literacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- Technical University of Cluj-Napoca, Romania, INSTITUTUL INIMII "NICOLAE STANCIOIU" CLUJ-NAPOCA, Romania, Tellu AS, Norway, Farsund Kommune, Norway, Karde AS, Norway
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRANSCARE Ecosystem Group | Experimental | Other: TRANSCARE Digital Remote Monitoring EcosystemParticipants 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Able to stand and walk even with support;
- Mini Mental State Examination (MMSE) ≥ 18;
- Clinical Frailty Scale (CFS) score 2-7;
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRANSCARE Digital Remote Monitoring EcosystemA 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. | Other | TRANSCARE Ecosystem Group |
Primary outcome
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.
6 secondary outcomes
Re-hospitalization Rate at 60 days
Time frame: 60 days post-discharge
Re-hospitalization Rate at 90 Days
Time frame: 90 days post-discharge
Change in Physical Performance
Time frame: Baseline, 30 days, 60 days, and 90 days post-discharge.
Platform Usability
Time frame: 30 days, 60 days, and 90 days post-discharge
Psychosocial Impact of Technology
Time frame: 30 days, 60 days, and 90 days post-discharge
Change in Digital Health Literacy
Time frame: Baseline and 90 days post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Transitional Care
Recruiting
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Liver Diseases
RecruitingPhase 3
A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer
Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma
Enrolling by invitation
BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery)
Traumatic Brain Injury
Active, not recruitingPhase 3
Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer
Metastatic Bladder Urothelial Carcinoma, Metastatic Urothelial Carcinoma
Active, not recruitingPhase 2
Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents
Fallopian Tube Mucinous Adenocarcinoma, Ovarian Seromucinous Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ionut Anghel, Prof. Dr. study chair
Technical University of Cluj-Napoca, Romania
Roberta Bevilacqua, Ph.D. principal investigator
IRCCS INRCA, Ancona, Italy
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRANSCARE Digital Remote Monitoring Ecosystem in people with Transitional Care and Remote Patient Monitoring (RPM), run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Norway, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Rita Bonfigli, PhD (0718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day Re-hospitalization Rate (time frame: 30 days post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.