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Clinical Trials/NCT06227923
NCT06227923
Completed
Not Applicable

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

Alberto Pilotto1 site in 1 country60 target enrollmentMay 28, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multimorbid and Poly-treated Older People
Sponsor
Alberto Pilotto
Enrollment
60
Locations
1
Primary Endpoint
Length of hospital stay
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 28, 2021
End Date
October 18, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Alberto Pilotto
Responsible Party
Sponsor Investigator
Principal Investigator

Alberto Pilotto

Director of Department of Geriatric Care, Orthogeriatrics and Rehabilitation

Ente Ospedaliero Ospedali Galliera

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Length of hospital stay

Time Frame: 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 Outcomes

  • Negative clinical outcome: re-hospitalization(1, 3 , 6 months after the baseline)
  • Step mean through smartwatch(At baseline)
  • Daily inactivity time through smartwatch(At baseline)
  • Negative clinical outcome: mortality(1, 3 , 6 months after the baseline)
  • Heart rate through smartwatch(At baseline)
  • Gait speed through kinect Azure(At baseline)
  • Negative clinical outcome: institutionalization(1, 3 , 6 months after the baseline)
  • Distance covered through smartwatch(At Baseline)
  • Trunk/head oscillation (body sway /lean in) through kinect Azure(At baseline)

Study Sites (1)

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