Clinical trial NCT06227923: A Protected Discharge Model Using Technology in Multimorbid and Poly-treated Older Subjects
Official title: Development and Validation of a Protected Discharge Model Using Technology in Multimorbidity and Poly-treated Older Subjects. The PRO-HOME Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multimorbid and Poly-treated Older People
Lead sponsor: Ente Ospedaliero Ospedali Galliera
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. participants aged 65 years or older;
2. admitted to the acute geriatric units for an acute event;
3. deemed stable and dischargeable from the hospital;
4. good personal autonomy in the Activities of Daily Living (ADL) (according to the Katz ADL scoring≥ 3/6);
5. normal cognition or mild cognitive impairment (Short Portable Mental Status Questionnaire (SPMSQ) ≤ 5/10);
6. signed informed consent

Exclusion Criteria:

1. participants aged less than 65 years old
2. not considerable stable and dischargeable
3. ADL \<3/6
4. SPMSQ \> 5/10
5. not signed informed consent

Primary outcomes:
measure: Length of hospital stay
timeFrame: At 1 month after the baseline
Secondary outcomes:
measure: Negative clinical outcome: re-hospitalization
timeFrame: 1, 3 , 6 months after the baseline
measure: Negative clinical outcome: institutionalization
timeFrame: 1, 3 , 6 months after the baseline
measure: Negative clinical outcome: mortality
timeFrame: 1, 3 , 6 months after the baseline
measure: Step mean through smartwatch
timeFrame: At baseline
measure: Heart rate through smartwatch
timeFrame: At baseline
measure: Daily inactivity time through smartwatch
timeFrame: At baseline
measure: Distance covered through smartwatch
timeFrame: At Baseline
measure: Gait speed through kinect Azure
timeFrame: At baseline
measure: Trunk/head oscillation (body sway /lean in) through kinect Azure
timeFrame: At baseline
Other outcomes:
Locations:
city: Genova
country: Italy
facility: EO Ospedali Galliera
Study officials:
affiliation: EO Galliera
name: Alberto Pilotto
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.