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The main goal of thi clinical trial is to evaluate if a protected discharge model can reduce the length of hospital stay in older participants aged over 65 years old who have been admitted to the hospital for an acute event and have been considered stable and dischargeable. Participants of the intervention group will be asked to transfer to a small apartment, inside the hospital setting, equipped by technological devices and to be involved in cognitive and physical activities during the stay. Researchers will compare this intervention group with a control group who receive normal clinical practice where older people remain in the hospital ward.
Participants who fit the inclusion criteria are randomized in two arms (intervention or control groups). All of them are evaluated with a comprehensive geriatric assessment (Multidimensional Prognostic Index), a depression scale (Geriatric Depression Scale), quality of Life scale (Short-Form 12 items), and physical parameters (Hand Grip, Short Physical Performance Battery, gait speed). In the intervention group the following clinical parameters will be collected through technological devices: spontaneous physical performance, sleep monitoring, gait speed, quality of movements, heart rate, SpO2, and other vital parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants are transferred from the hospital ward to a small apartment with a technological assessment and monitoring established inside the hospital setting. |
|
| Control group | No Intervention | Participants remain in the hospital ward and receive normal clinical practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-HOME intervention | Device | Patients are transferred to the apartment inside the hospital setting and are evaluated and assessed also using technological devices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Evaluate the efficacy of a protected discharge model in terms of length of hospital stay in multimorbid and poly-treated older subjects | At 1 month after the baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Negative clinical outcome: re-hospitalization | Evaluate negative clinical outcome about re-hospitalization recording the number of re-hospitalization (number of access in the hospital's wards and related reason) related to each patient after the intervention if relevant | 1, 3 , 6 months after the baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Pilotto | EO Galliera | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EO Ospedali Galliera | Genova | 16128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37890856 | Background | Pilotto A, Volta E, Barbagelata M, Argusti A, Camurri A, Casiddu N, Berutti-Bergotto C, Custodero C, Cella A. The PRO-HOME Project. A multicomponent intervention for the protected discharge from the hospital of multimorbid and polytreated older individuals by using innovative technologies: A pilot study. Health Expect. 2024 Feb;27(1):e13872. doi: 10.1111/hex.13872. Epub 2023 Oct 27. | |
| 37972433 |
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Results will be published in one or more different papers with only statistically significant data with the description of statistical methods of the analyses.
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Randomized clinical trial
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| Negative clinical outcome: institutionalization |
Evaluate negative clinical outcome about institutionalization recording the access in institution related to each patient after the intervention, if relevant |
| 1, 3 , 6 months after the baseline |
| Negative clinical outcome: mortality | Evaluate negative clinical outcome about mortality collecting the data about mortality (date and reason of death) if relevant | 1, 3 , 6 months after the baseline |
| Step mean through smartwatch | Units of measure: number of steps | At baseline |
| Heart rate through smartwatch | Units of measure: bpm | At baseline |
| Daily inactivity time through smartwatch | Units of measure: percentage of time spent inactive | At baseline |
| Distance covered through smartwatch | Units of measure: cm | At Baseline |
| Gait speed through kinect Azure | Units of measure:meters/second | At baseline |
| Trunk/head oscillation (body sway /lean in) through kinect Azure | Units of measure: degrees | At baseline |
| Background |
| Pilotto A, Barbagelata M, Morganti W, Seminerio E, Iaccarino G, Genazzani A, Trompetto C, Arabia G, Illario M, Volta E, Custodero C, Cella A; MULTIPLAT_AGE Investigators. Development and implementation of multicomponent homecare interventions for multimorbid and frail older people based on Information and Communication Technologies: The MULTIPLAT_AGE project. Arch Gerontol Geriatr. 2024 Feb;117:105252. doi: 10.1016/j.archger.2023.105252. Epub 2023 Nov 3. |
| 39105934 | Derived | Pilotto A, Morganti W, Barbagelata M, Seminerio E, Morelli S, Custureri R, Dini S, Senesi B, Prete C, Puleo G, Berutti Bergotto C, Vallone F, Custodero C, Camurri A; PRO-HOME Project Investigators Group. A transitional care program in a technologically monitored in-hospital facility reduces the length of hospital stay and improves multidimensional frailty in older patients: a Randomized Clinical Trial. Aging Clin Exp Res. 2024 Aug 6;36(1):160. doi: 10.1007/s40520-024-02821-8. |