Geriatric Multimorbidity, Remote Patient Monitoring (RPM), Transitional Care
Conditions
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
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.
Interventions
OTHERTRANSCARE Digital Remote Monitoring Ecosystem
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.
Sponsors
Istituto Nazionale di Ricovero e Cura per Anziani
Technical University of Cluj-Napoca, Romania
INSTITUTUL INIMII "NICOLAE STANCIOIU" CLUJ-NAPOCA, Romania
Tellu AS, Norway
Farsund Kommune, Norway
Karde AS, Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-Day Re-hospitalization Rate | 30 days post-discharge | Percentage of participants re-admitted to the hospital for any all-cause unplanned readmission within 30 days following discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-hospitalization Rate at 60 days | 60 days post-discharge | Percentage of participants with all-cause unplanned hospital readmissions evaluated at 60 days post-discharge. |
| Re-hospitalization Rate at 90 Days | 90 days post-discharge | Percentage of participants with all-cause unplanned hospital readmissions evaluated at 90 days post-discharge |
| Change in Physical Performance | 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). |
| Platform Usability | 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) |
| Psychosocial Impact of Technology | 30 days, 60 days, and 90 days post-discharge | The perceived impact evaluated through the Psychosocial Impact of Assistive Devices Scale (PIADS) |
| Change in Digital Health Literacy | 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). |
Countries
Italy, Norway, Romania
Contacts
CONTACTAnna Rita Bonfigli, PhD
STUDY_CHAIRIonut Anghel, Prof. Dr.
Technical University of Cluj-Napoca, Romania
PRINCIPAL_INVESTIGATORRoberta Bevilacqua, Ph.D.
IRCCS INRCA, Ancona, Italy
Outcome results
None listed