Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions

University of Milano Bicocca288 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Interventions

Multidomain InterventionsOTHER

Multidomain Interventions The intervention group will receive a personalized MDI approach from a multidisciplinary team, including a digital coach, physiotherapist, clinical nutrition expert, neuropsychologist, geriatrician, and nurse. This approach will encompass physical activity program, nutritional interventions, cognitive training and stimulation, medication reconciliation, coaching on the use of technological supports, and group activities. Environmental modifications at home will also be proposed

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>70 years; * Mild to moderate frailty, defined by a panel of tools agreed upon by the group of researchers involved in the study (Primary Care Frailty Index \[PC-FI\] between 0.07 and 0.21, Clinical Frailty Scale \[CFS\] 4-6); * Ability to walk with or without assistance * Ability to communicate and cooperate with the research team; * Ability to sign informed consent. Exclusion Criteria: * Expected hospital stay duration \<3 days; * Estimated prognosis quoad vitam \<12 months; * Persistent clinical instability, indicated by a NEWS2 score \>5 (assessed within 48 hours of admission) and/or the presence of delirium (4AT \>4); * History of schizophrenia, major depression, bipolar disorder, or psychosis; * Severe sensory deficits (visual and auditory); * Presence of a nasogastric tube or percutaneous endoscopic gastrostomy (PEG); * Severe cardiac conduction disorder (e.g., third-degree atrioventricular block), uncontrolled arrhythmia, new Q wave in the past six months, or ST segment depression (\>3 mm) on the electrocardiogram; * Terminal stage oncological or organic disease (e.g., Child-Pugh C cirrhosis, stage V renal disease, GOLD stage D chronic obstructive pulmonary disease, end-stage heart failure); * Residence in a nursing home before hospital admission; * Presence of dissected aortic aneurysm, severe aortic stenosis, acute endocarditis/pericarditis, acute thromboembolism, uncontrolled hypertension (\>180/100 mmHg) or postural hypotension, uncontrolled hypoglycemia, recent fracture within the last month, or any other medical condition that hinders the execution of physical activity according to clinical judgment; * Any condition that prevents safe participation in the intervention and/or cooperation with the study; * Concurrent participation in other clinical studies; * Clinical conditions or situations significantly different from the condition under study, which in the investigator's opinion could interfere with the study or prevent optimal participation; * Participants refusal to participate in the study.

Outcomes

Primary Outcomes

Evaluate the feasibility of home-based MDI with technological support

Feasibility of home-based MDI with technological support, evaluated using Patient Reported Experience Measures (PREMs), questionnaires measuring the patients' perceptions of their experience whilst receiving care

Time frame: 3 months, and 6 months

Evaluate the participant adherence to the protocol

Evaluate the participant adherence to the protocol assessing the number of drop-out and overall retention rates

Time frame: through study completion, an average of 1 year

Assess the effect of the MDI on motor function at discharge from the AGU

Effect of the intervention in terms of motor function, assessed using the Short Physical Performance Battery (SPPB, from 0 to 12)

Time frame: Baseline, Discharge (after an average hospital stay of 10 days)

Secondary Outcomes

Assess the effect of the MDI on readmissions at 6 months follow-up.

Effect of the MDI in reducing hospital readmissions at 6 months

Time frame: 6 months

Assess the effect of the MDI on readmissions at 3 months follow-up.

Effect of the MDI in reducing hospital readmissions at 3 months

Time frame: 3 months

Evaluate the effect of the MDI on quality of life at follow-up.

Effect of the MDI on participants' quality of life at follow-up, evaluated using the EuroQol EQ-5D 5L, a descriptive system comprising five dimensions (mobility, self-care, usual activities, discomfort, and anxiety/depression), each dimension with five response levels (no problems, slight problems, moderate problems, severe problems, unable to/extreme problems).

Time frame: 3 months, 6 months

Evaluate the effect of the MDI on in-hospital mortality

Time frame: From Admission Through Discharge, an Average of 10 days

Evaluate the effect of the MDI on mortality at follow-up.

Time frame: 3 months, 6 months

Evaluate the effect of the MDI on dietary intake and nutritional status at follow-up.

Effect of the MDI in improving dietary intake and nutritional status at follow-up, assessed using the Mediterranean Diet Scale (MDScale, that includes nine components) and Mini Nutritional Assessment-Short Form (MNA-SF, 0-14)

Time frame: Baseline, 3 months, 6 months

Evaluate the effect of the MDI on changes in frailty levels at follow-up.

Effect of the MDI in reducing frailty at follow-up, assessed using the Clinical Frailty Scale (CFS, 0-9) and Primary Care Frailty Index (PC-FI)

Time frame: Baseline, 3 months, 6 months

Assess the effect of the MDI on fall events

Effect of the MDI in reducing the incidence of falls during hospitalization and at home, evaluated through the number of falls and the Tinetti Scale (0-28) occurred within the study period