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

NCT06227923 | Completed

• 1 other identifier: NET-2016-02361805-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multimorbid and Poly-treated Older People

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Negative clinical outcome: re-hospitalization

  1, 3 , 6 months after the baseline

• Negative clinical outcome: institutionalization

  1, 3 , 6 months after the baseline

• Negative clinical outcome: mortality

  1, 3 , 6 months after the baseline

• Step mean through smartwatch

  At baseline

• Heart rate through smartwatch

  At baseline

Study Arms (2)

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.

Device: PRO-HOME intervention

Control group

NO INTERVENTION

Participants remain in the hospital ward and receive normal clinical practice.

Interventions

PRO-HOME intervention DEVICE

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

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alberto Pilotto: lead

Study Sites (1)

EO Ospedali Galliera

Genova, 16128, Italy

Location

Related Publications (3)

• 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.

  PMID: 37890856 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.

  PMID: 37972433 BACKGROUND

• 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.

  PMID: 39105934 DERIVED

Study Officials

• Alberto Pilotto

  EO Galliera

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Department of Geriatric Care, Orthogeriatrics and Rehabilitation

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 29, 2024
• Study Start: May 28, 2021
• Primary Completion: April 18, 2023
• Study Completion: October 18, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)