Aging, Frailty Syndrome
Conditions
Keywords
Hospital Acquired Disability, Frailty Syndrome, Comprehensive Geriatric Assessment, Prevention, Integrated Multidomain Interventions, Telemedicine, Telemonitoring, Outcomes, Hospital
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.
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.
Interventions
OTHERMultidomain Interventions
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
Sponsors
University of Milano Bicocca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Pragmatic, randomized controlled (parallel-arm cluster), non-drug interventional clinical study
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the effect of the MDI on motor function at discharge from the AGU | Baseline, Discharge (after an average hospital stay of 10 days) | Effect of the intervention in terms of motor function, assessed using the Short Physical Performance Battery (SPPB, from 0 to 12) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the effect of the MDI on readmissions at 6 months follow-up. | 6 months | Effect of the MDI in reducing hospital readmissions at 6 months |
| Evaluate the participant adherence to the protocol | 6 months | Evaluate the participant adherence to the protocol assessing the number of drop-out and overall retention rates |
| Evaluate the feasibility of home-based MDI with technological support | 3 months, and 6 months | 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 |
| Assess the effect of the MDI on readmissions at 3 months follow-up. | 3 months | Effect of the MDI in reducing hospital readmissions at 3 months |
| Evaluate the effect of the MDI on quality of life at follow-up. | 3 months, 6 months | 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). |
| Evaluate the effect of the MDI on in-hospital mortality | From Admission Through Discharge, an Average of 10 days | Evaluate the effect of the MDI on in-hospital mortality |
| Evaluate the effect of the MDI on mortality at follow-up. | 3 months, 6 months | Evaluate the effect of the MDI on mortality at follow-up. |
| Evaluate the effect of the MDI on dietary intake and nutritional status at follow-up. | Baseline, 3 months, 6 months | 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) |
| Evaluate the effect of the MDI on changes in frailty levels at follow-up. | Baseline, 3 months, 6 months | 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) |
| Assess the effect of the MDI on fall events | Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months | 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 |
| Evaluate the effect of the MDI on in-hospital complications | Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months | Effect of the MDI in reducing the incidence of in-hospital complications as sepsis, urinary infections, blood infections, and pressure ulcers. |
| Assess the effect of the MDI on sleep quality | Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months | Effect of the MDI on sleep quality during hospitalization and at home, assessed using the Pittsburgh Sleep Quality Index (PSQI). The questionnaire consists of a combination of Likert-type and open-ended questions (which can later be converted into scaled scores using appropriate guidelines). |
| Assess the effect of the MDI on the incidence of delirium during hospitalization | From Admission Through Discharge, an Average of 10 days | Effect of the MDI in reducing incident delirium during hospitalization, diagnosed according to international guidelines (DSM V) and assessed using the Modified Richmond Agitation Screening Scale (m-RASS, scoring from -5 to +4), 4AT (scoring, from 0 to 12), and Delirium Rating Scale (DRS-revised, 13 items, each item is rated on a scale of 0- 2/3) |
| Assess the effect of the MDI on cognitive performance at follow-up. | Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months | Effect of the MDI on cognitive performance (assessed using the Cognitive Reserve Index questionnaire (CRIq), Addenbrooke Cognitive Examination - Revised (ACE-R), Trail Making Test (TMT) parts A and B) |
| Assess the effect of the MDI on functional performance at follow-up | Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months | Assessed using Basic Activities of Daily Living (ADL 0-6), Instrumental Activities of Daily Living (IADL 0-8), Barthel Index at follow-up (0-100) |
| Assess the effect of the MDI on motor performance at follow-up. | Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months | Assessed using SPPB (0-12), hand grip strength (Kg) |
| Assess the acceptability of technological solutions during hospitalization and at follow-up. | Discharge (after an average hospital stay of 10 days), 3 months, and 6 months | Acceptability of technological solutions through the administration of specific questionnaires |
| Evaluate the cost impact of the MDI on the healthcare system. | Discharge (after an average hospital stay of 10 days), 3 months, and 6 months | Costs of the MDI on the healthcare system, evaluated through the incremental cost-effectiveness ratio |
| Evaluate the effect of the MDI on the length of hospital stay. | Discharge (after an average hospital stay of 10 days) | Effect of the MDI in reducing the length of hospital stay |
Countries
Italy
Contacts
CONTACTGiuseppe Bellelli, MD
PRINCIPAL_INVESTIGATORGiuseppe Bellelli, MD
Università di Milano-Bicocca
STUDY_CHAIRGiuseppe Bellelli, MD
Università di Milano-Bicocca
Outcome results
None listed