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

NCT ID: NCT06227923

Last Updated: 2024-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-28

Study Completion Date

2023-10-18

Brief Summary

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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

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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.

Conditions

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Multimorbid and Poly-treated Older People

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Participants are transferred from the hospital ward to a small apartment with a technological assessment and monitoring established inside the hospital setting.

Group Type EXPERIMENTAL

PRO-HOME intervention

Intervention Type DEVICE

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PRO-HOME intervention

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberto Pilotto

OTHER

Sponsor Role lead

Responsible Party

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Alberto Pilotto

Director of Department of Geriatric Care, Orthogeriatrics and Rehabilitation

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Alberto Pilotto

Role: PRINCIPAL_INVESTIGATOR

EO Galliera

Locations

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EO Ospedali Galliera

Genova, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 37890856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37972433 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39105934 (View on PubMed)

Other Identifiers

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NET-2016-02361805-1

Identifier Type: -

Identifier Source: org_study_id

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