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A Protected Discharge Model Using Technology in Multimorbid and Poly-treated Older Subjects

Development and Validation of a Protected Discharge Model Using Technology in Multimorbidity and Poly-treated Older Subjects. The PRO-HOME Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06227923
Acronym
PRO-HOME
Enrollment
60
Registered
2024-01-29
Start date
2021-05-28
Completion date
2023-10-18
Last updated
2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multimorbid and Poly-treated Older People

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.

Interventions

DEVICEPRO-HOME intervention

Patients are transferred to the apartment inside the hospital setting and are evaluated and assessed also using technological devices

Sponsors

Alberto Pilotto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of hospital stayAt 1 month after the baselineEvaluate the efficacy of a protected discharge model in terms of length of hospital stay in multimorbid and poly-treated older subjects

Secondary

MeasureTime frameDescription
Negative clinical outcome: institutionalization1, 3 , 6 months after the baselineEvaluate negative clinical outcome about institutionalization recording the access in institution related to each patient after the intervention, if relevant
Negative clinical outcome: mortality1, 3 , 6 months after the baselineEvaluate negative clinical outcome about mortality collecting the data about mortality (date and reason of death) if relevant
Step mean through smartwatchAt baselineUnits of measure: number of steps
Heart rate through smartwatchAt baselineUnits of measure: bpm
Negative clinical outcome: re-hospitalization1, 3 , 6 months after the baselineEvaluate 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
Distance covered through smartwatchAt BaselineUnits of measure: cm
Gait speed through kinect AzureAt baselineUnits of measure:meters/second
Trunk/head oscillation (body sway /lean in) through kinect AzureAt baselineUnits of measure: degrees
Daily inactivity time through smartwatchAt baselineUnits of measure: percentage of time spent inactive

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026