Multimorbid and Poly-treated Older PeoplePRO-HOMENCT06227923
A Protected Discharge Model Using Technology in Multimorbid and Poly-treated Older Subjects
A study testing PRO-HOME intervention in people with Multimorbid and Poly-treated Older People, run by Alberto Pilotto at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multimorbid and Poly-treated Older People
- What is being tested?
- PRO-HOME intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 28 May 2021to 18 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- participants aged less than 65 years old
- not considerable stable and dischargeable
- ADL <3/6
- SPMSQ > 5/10
- not signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- PRO-HOME intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-HOME interventionDevice
Patients are transferred to the apartment inside the hospital setting and are evaluated and assessed also using technological devices
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PRO-HOME intervention |
| Control group | No intervention | Participants remain in the hospital ward and receive normal clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 1 month after the baseline
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 1, 3 , 6 months after the baseline
Step mean through smartwatch
Units of measure: number of steps
Measured: At baseline
Heart rate through smartwatch
Units of measure: bpm
Measured: At baseline
Daily inactivity time through smartwatch
Units of measure: percentage of time spent inactive
Measured: At baseline
Distance covered through smartwatch
Units of measure: cm
Measured: At Baseline
Gait speed through kinect Azure
Units of measure:meters/second
Measured: At baseline
Trunk/head oscillation (body sway /lean in) through kinect Azure
Units of measure: degrees
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start28 May 2021
- Primary completion18 Apr 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multimorbid and Poly-treated Older PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alberto Pilotto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alberto Pilotto, Ente Ospedaliero Ospedali Galliera
- Investigators
- Alberto Pilotto, Principal investigator, EO Galliera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227923
- Sponsor's protocol ID
- NET-2016-02361805-1
- Acronym
- PRO-HOME
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be published in one or more different papers with only statistically significant data with the description of statistical methods of the analyses.
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. 2024 Feb;27(1):e13872. doi: 10.1111/hex.13872. Epub 2023 Oct 27.
PubMed 37890856Pilotto 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.
PubMed 37972433Pilotto 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.
PubMed 39105934
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Protected Discharge Model Using Technology in Multimorbidity and Poly-treated Older Subjects. The PRO-HOME Study
- ClinicalTrials.gov ID
- NCT06227923
- Acronym / sponsor ID
- PRO-HOME / NET-2016-02361805-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alberto PilottoUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: PRO-HOME interventionParticipants are transferred from the hospital ward to a small apartment with a technological assessment and monitoring established inside the hospital setting. |
| Control group | No intervention | –Participants remain in the hospital ward and receive normal clinical practice. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (5 listed)
- participants aged less than 65 years old
- not considerable stable and dischargeable
- ADL <3/6
- SPMSQ > 5/10
- not signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO-HOME interventionPatients are transferred to the apartment inside the hospital setting and are evaluated and assessed also using technological devices | Device | Intervention group |
Primary outcome
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
9 secondary outcomes
Negative clinical outcome: re-hospitalization
Time frame: 1, 3 , 6 months after the baseline
Negative clinical outcome: institutionalization
Time frame: 1, 3 , 6 months after the baseline
Negative clinical outcome: mortality
Time frame: 1, 3 , 6 months after the baseline
Step mean through smartwatch
Time frame: At baseline
Heart rate through smartwatch
Time frame: At baseline
Daily inactivity time through smartwatch
Time frame: At baseline
Distance covered through smartwatch
Time frame: At Baseline
Gait speed through kinect Azure
Time frame: At baseline
Trunk/head oscillation (body sway /lean in) through kinect Azure
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Background: PubMed 37890856Pilotto 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.
- Background: PubMed 37972433Pilotto 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.
- Derived from this study: PubMed 39105934Pilotto 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.
- Individual participant dataSharing planned: No. Results will be published in one or more different papers with only statistically significant data with the description of statistical methods of the analyses.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Pilotto principal investigator
EO Galliera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRO-HOME intervention in people with Multimorbid and Poly-treated Older People, run by Alberto Pilotto at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: At 1 month after the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06227923, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.