Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions

Official title

Optimizing Prevention of Hospital-acquired Disability Through Integrated Multidomain Interventions: the Age-IT Project

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.

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

• Other Multidomain 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

Primary outcome measures

• Assess the effect of the MDI on motor function at discharge from the AGU [Time frame: Baseline, Discharge (after an average hospital stay of 10 days)]

Secondary outcome measures (12)

• Assess the effect of the MDI on readmissions at 6 months follow-up. [Time frame: 6 months]
• Evaluate the participant adherence to the protocol [Time frame: 6 months]
• Evaluate the feasibility of home-based MDI with technological support [Time frame: 3 months, and 6 months]
• Assess the effect of the MDI on readmissions at 3 months follow-up. [Time frame: 3 months]
• Evaluate the effect of the MDI on quality of life at follow-up. [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. [Time frame: Baseline, 3 months, 6 months]
• Evaluate the effect of the MDI on changes in frailty levels at follow-up. [Time frame: Baseline, 3 months, 6 months]
• Assess the effect of the MDI on fall events [Time frame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months]
• Evaluate the effect of the MDI on in-hospital complications [Time frame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months]
• Assess the effect of the MDI on sleep quality [Time frame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Italy · 1 center

• Fondazione IRCCS San Gerardo dei Tintori — Monza

Publications

• Belloni G, Cesari M. Frailty and Intrinsic Capacity: Two Distinct but Related Constructs. Front Med (Lausanne). 2019 Jun 18;6:133. doi: 10.3389/fmed.2019.00133. eCollection 2019. PMID 31275941
• Dent E, Martin FC, Bergman H, Woo J, Romero-Ortuno R, Walston JD. Management of frailty: opportunities, challenges, and future directions. Lancet. 2019 Oct 12;394(10206):1376-1386. doi: 10.1016/S0140-6736(19)31785-4. PMID 31609229
• Thillainadesan J, Scott IA, Le Couteur DG. Frailty, a multisystem ageing syndrome. Age Ageing. 2020 Aug 24;49(5):758-763. doi: 10.1093/ageing/afaa112. PMID 32542377
• Lee H, Lee E, Jang IY. Frailty and Comprehensive Geriatric Assessment. J Korean Med Sci. 2020 Jan 20;35(3):e16. doi: 10.3346/jkms.2020.35.e16. PMID 31950775
• Dedeyne L, Deschodt M, Verschueren S, Tournoy J, Gielen E. Effects of multi-domain interventions in (pre)frail elderly on frailty, functional, and cognitive status: a systematic review. Clin Interv Aging. 2017 May 24;12:873-896. doi: 10.2147/CIA.S130794. eCollection 2017. PMID 28579766
• de Souto Barreto P, Rolland Y, Maltais M, Vellas B; MAPT Study Group. Associations of Multidomain Lifestyle Intervention with Frailty: Secondary Analysis of a Randomized Controlled Trial. Am J Med. 2018 Nov;131(11):1382.e7-1382.e13. doi: 10.1016/j.amjmed.2018.06.002. Epub 2018 Jul 1. PMID 29969614
• Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cog PMID 25771249
• Ellis G, Gardner M, Tsiachristas A, Langhorne P, Burke O, Harwood RH, Conroy SP, Kircher T, Somme D, Saltvedt I, Wald H, O'Neill D, Robinson D, Shepperd S. Comprehensive geriatric assessment for older adults admitted to hospital. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD006211. doi: 10.1002/14651858.CD006211.pub3. PMID 28898390

Identifiers

NCT: NCT06611228 · OPTIMAge-IT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗