Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611228
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Prevention of Hospital-acquired Disability Through Integrated Multidomain Interventions the Age-IT Project
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMAge-IT
Brief Summary:
The aim of this study is to assess whether a multidomain multidisciplinary intervention MDI enhanced by technological solutions effectively improves the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty Additionally the study will evaluate the feasibility and acceptability of delivering these interventions remotely via technology after hospital discharge
Participants will
Receive an MDI during their hospital stay and continue with remote at-home support for 3 months or receive usual care
Attend outpatient clinics for follow-up assessment at 3 and 6 months
Participants will
Receive an MDI during their hospital stay and continue with remote at-home support for 3 months or receive usual care
Attend outpatient clinics for follow-up assessment at 3 and 6 months
Detailed Description:
The Optimizing Prevention of Hospital-Acquired Disability Through Integrated Multidomain Interventions OPTIMAge-IT study will evaluate impact of a MDI multidisciplinary approach enhanced by technological solutions on the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty
Additionally the study will evaluate the feasibility and acceptability of delivering MDIs remotely via technology after hospital discharge Using a parallel cluster-randomized design approximately 300 patients will be recruited from eight Acute Geriatric Units AGUs located in eight acute hospitals evenly distributed across Northern Central and Southern Italy
Eligible patients will be aged 70 years or older with mild to moderate frailty capable of ambulation with or without assistance and able to communicate and collaborate with the research team Participants will use smart technologies such as smartwatches and tablets for guided physical activity and remote monitoring A multidisciplinary team -including a geriatrician a nurse a physiotherapist a clinical nutrition expert a neuropsychologist and a digital coach- will assist patients in the intervention group supervising the MDI approach during hospitalization and at the 3-month follow-up Blood-based biomarkers and fecal samples for gut microbiome analysis will be collected for patients in the intervention group to support frailty stratification at baseline and help define the trajectories of functional and cognitive changes from baseline to follow-up assessments
After discharge patients in the intervention group will continue MDI at home for 12 weeks with follow-up visits at 3 and 6 months The control group will receive a follow-up visit at 6 months
Additionally the study will evaluate the feasibility and acceptability of delivering MDIs remotely via technology after hospital discharge Using a parallel cluster-randomized design approximately 300 patients will be recruited from eight Acute Geriatric Units AGUs located in eight acute hospitals evenly distributed across Northern Central and Southern Italy
Eligible patients will be aged 70 years or older with mild to moderate frailty capable of ambulation with or without assistance and able to communicate and collaborate with the research team Participants will use smart technologies such as smartwatches and tablets for guided physical activity and remote monitoring A multidisciplinary team -including a geriatrician a nurse a physiotherapist a clinical nutrition expert a neuropsychologist and a digital coach- will assist patients in the intervention group supervising the MDI approach during hospitalization and at the 3-month follow-up Blood-based biomarkers and fecal samples for gut microbiome analysis will be collected for patients in the intervention group to support frailty stratification at baseline and help define the trajectories of functional and cognitive changes from baseline to follow-up assessments
After discharge patients in the intervention group will continue MDI at home for 12 weeks with follow-up visits at 3 and 6 months The control group will receive a follow-up visit at 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None