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

Not Applicable

Completed

• Conditions: Multimorbid and Poly-treated Older People
• Interventions: Device: PRO-HOME intervention

• Registration Number: NCT06227923
• Lead Sponsor: Alberto Pilotto

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.

Study Timeline

• Study Start: 2021-05-28
• Primary Completion: 2023-04-18
• Study Completion: 2023-10-18
• Study First Submitted: 2023-12-22
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-18
• Last Update Submitted: 2024-01-18
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	PRO-HOME intervention	Participants are transferred from the hospital ward to a small apartment with a technological assessment and monitoring established inside the hospital setting.

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	At 1 month after the baseline	Evaluate the efficacy of a protected discharge model in terms of length of hospital stay in multimorbid and poly-treated older subjects

Secondary Outcome Measures

Name	Time	Method
Negative clinical outcome: re-hospitalization	1, 3 , 6 months after the baseline	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
Step mean through smartwatch	At baseline	Units of measure: number of steps
Daily inactivity time through smartwatch	At baseline	Units of measure: percentage of time spent inactive
Negative clinical outcome: institutionalization	1, 3 , 6 months after the baseline	Evaluate negative clinical outcome about institutionalization recording the access in institution related to each patient after the intervention, if relevant
Negative clinical outcome: mortality	1, 3 , 6 months after the baseline	Evaluate negative clinical outcome about mortality collecting the data about mortality (date and reason of death) if relevant
Heart rate through smartwatch	At baseline	Units of measure: bpm
Gait speed through kinect Azure	At baseline	Units of measure:meters/second
Distance covered through smartwatch	At Baseline	Units of measure: cm
Trunk/head oscillation (body sway /lean in) through kinect Azure	At baseline	Units of measure: degrees

Trial Locations

Locations (1)

EO Ospedali Galliera; 🇮🇹 Genova, Italy