A Protected Discharge Model Using Technology in Multimorbid and Poly-treated Older Subjects (PRO-HOME)

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

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.

Study Overview

• Status: Completed
• Conditions: Multimorbid and Poly-treated Older People
• Intervention / Treatment: Device: PRO-HOME intervention

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Genova, Italy, 16128
    • EO Ospedali Galliera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants are transferred from the hospital ward to a small apartment with a technological assessment and monitoring established inside the hospital setting.	Device: PRO-HOME intervention; Patients are transferred to the apartment inside the hospital setting and are evaluated and assessed also using technological devices
No Intervention: Control group; Participants remain in the hospital ward and receive normal clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Alberto Pilotto
• Investigators: Principal Investigator: Alberto Pilotto, EO Galliera

Publications and helpful links

General Publications

• 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. 2023 Oct 27;27(1):e13872. doi: 10.1111/hex.13872. Online ahead of print.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Actual): April 18, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Estimated): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NET-2016-02361805-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results will be published in one or more different papers with only statistically significant data with the description of statistical methods of the analyses.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No