Clinical trial NCT06611228: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty Syndrome
Aging
Keywords: Hospital Acquired Disability
Frailty Syndrome
Comprehensive Geriatric Assessment
Prevention
Integrated Multidomain Interventions
Telemedicine
Telemonitoring
Outcomes
Hospital
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 288
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, randomized controlled (parallel-arm cluster), non-drug interventional clinical study
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Age \&gt;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 \&lt;3 days;
* Estimated prognosis quoad vitam \&lt;12 months;
* Persistent clinical instability, indicated by a NEWS2 score \&gt;5 (assessed within 48 hours of admission) and/or the presence of delirium (4AT \&gt;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 (\&gt;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 (\&gt;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.

Primary outcomes:
measure: Evaluate the feasibility of home-based MDI with technological support
timeFrame: 3 months, and 6 months
measure: Evaluate the participant adherence to the protocol
timeFrame: through study completion, an average of 1 year
measure: Assess the effect of the MDI on motor function at discharge from the AGU
timeFrame: Baseline, Discharge (after an average hospital stay of 10 days)
Secondary outcomes:
measure: Assess the effect of the MDI on readmissions at 6 months follow-up.
timeFrame: 6 months
measure: Assess the effect of the MDI on readmissions at 3 months follow-up.
timeFrame: 3 months
measure: Evaluate the effect of the MDI on quality of life at follow-up.
timeFrame: 3 months, 6 months
measure: Evaluate the effect of the MDI on in-hospital mortality
timeFrame: From Admission Through Discharge, an Average of 10 days
measure: Evaluate the effect of the MDI on mortality at follow-up.
timeFrame: 3 months, 6 months
measure: Evaluate the effect of the MDI on dietary intake and nutritional status at follow-up.
timeFrame: Baseline, 3 months, 6 months
measure: Evaluate the effect of the MDI on changes in frailty levels at follow-up.
timeFrame: Baseline, 3 months, 6 months
measure: Assess the effect of the MDI on fall events
timeFrame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
measure: Evaluate the effect of the MDI on in-hospital complications
timeFrame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
measure: Assess the effect of the MDI on sleep quality
timeFrame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
measure: Assess the effect of the MDI on the incidence of delirium during hospitalization
timeFrame: From Admission Through Discharge, an Average of 10 days
measure: Assess the effect of the MDI on cognitive performance at follow-up.
timeFrame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
measure: Assess the effect of the MDI on functional performance at follow-up
timeFrame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
measure: Assess the effect of the MDI on motor performance at follow-up.
timeFrame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
measure: Assess the acceptability of technological solutions during hospitalization and at follow-up.
timeFrame: Discharge (after an average hospital stay of 10 days), 3 months, and 6 months
measure: Evaluate the cost impact of the MDI on the healthcare system.
timeFrame: Discharge (after an average hospital stay of 10 days), 3 months, and 6 months
measure: Evaluate the effect of the MDI on the length of hospital stay.
timeFrame: Discharge (after an average hospital stay of 10 days)
Other outcomes:
measure: Assess the impact of the MDI on cardiovascular risk factors.
timeFrame: Baseline, 6 months
measure: Evaluate the effect of the MDI on participants&amp;amp;amp;amp;#39; social relationships.
timeFrame: 3 months, 6 months
measure: Evaluate the impact of fortified food consumption on microbiota composition and bowel alterations in a subgroup of patients not undergoing antibiotic therapy (ancillary study).
timeFrame: Baseline, Through Discharge an Average of 10 days
measure: Assess participants access to (and frequency of use of) technological resources.
timeFrame: Through Discharge an Average of 10 days, 3 months
measure: Assess the effect of the MDI on mood of participants
timeFrame: Baseline, 3 months, 6 months
measure: Evaluate the effect of the MDI on biomarkers of aging
timeFrame: Baseline, 6 months
measure: Evaluate the effect of the MDI on biomarkers of aging
timeFrame: Baseline
measure: Evaluate the effect of the MDI on biomarkers of aging
timeFrame: Baseline
measure: Evaluate the effect of the MDI on biomarkers of aging
timeFrame: Baseline, 6 months
measure: Evaluate the effect of the MDI on biomarkers of aging
timeFrame: Baseline, 6 months
measure: Evaluate the effect of the MDI on biomarkers of aging
timeFrame: Baseline, 6 months
measure: Evaluate the effect of the MDI on biomarkers of aging
timeFrame: Baseline, 6 months
measure: Evaluate the effect of the MDI on biomarkers of aging
timeFrame: Baseline, 6 months
measure: Evaluate the effect of the MDI on biomarkers of aging
timeFrame: Baseline, 6 months
measure: Evaluate the effect of the MDI on biomarkers of aging
timeFrame: Baseline, 6 months
Locations:
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
state: Lumbardy
Study officials:
affiliation: Università di Milano-Bicocca
name: Giuseppe Bellelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Università di Milano-Bicocca
name: Giuseppe Bellelli, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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 cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
citation: 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.
citation: Ferrara MC, Perez LM, Sole AR, Villa-Garcia L, Ars J, Soto-Bagaria L, Bellelli G, Cesari M, Enfedaque MB, Inzitari M. Sustained improvement of intrinsic capacity in community-dwelling older adults: The +AGIL Barcelona multidomain program. J Intern Med. 2023 Dec;294(6):730-742. doi: 10.1111/joim.13710. Epub 2023 Aug 21.
citation: Kivipelto M, Mangialasche F, Ngandu T. Lifestyle interventions to prevent cognitive impairment, dementia and Alzheimer disease. Nat Rev Neurol. 2018 Nov;14(11):653-666. doi: 10.1038/s41582-018-0070-3.
citation: Perez LM, Enfedaque-Montes MB, Cesari M, Soto-Bagaria L, Gual N, Burbano MP, Tarazona-Santabalbina FJ, Casas RM, Diaz F, Martin E, Gomez A, Orfila F, Inzitari M. A Community Program of Integrated Care for Frail Older Adults: +AGIL Barcelona. J Nutr Health Aging. 2019;23(8):710-716. doi: 10.1007/s12603-019-1244-4.
citation: Casas-Herrero A, Saez de Asteasu ML, Anton-Rodrigo I, Sanchez-Sanchez JL, Montero-Odasso M, Marin-Epelde I, Ramon-Espinoza F, Zambom-Ferraresi F, Petidier-Torregrosa R, Elexpuru-Estomba J, Alvarez-Bustos A, Galbete A, Martinez-Velilla N, Izquierdo M. Effects of Vivifrail multicomponent intervention on functional capacity: a multicentre, randomized controlled trial. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):884-893. doi: 10.1002/jcsm.12925. Epub 2022 Feb 11.
citation: Courel-Ibanez J, Buendia-Romero A, Pallares JG, Garcia-Conesa S, Martinez-Cava A, Izquierdo M. Impact of Tailored Multicomponent Exercise for Preventing Weakness and Falls on Nursing Home Residents' Functional Capacity. J Am Med Dir Assoc. 2022 Jan;23(1):98-104.e3. doi: 10.1016/j.jamda.2021.05.037. Epub 2021 Jun 29.
citation: Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Saez de Asteasu ML, Lucia A, Galbete A, Garcia-Baztan A, Alonso-Renedo J, Gonzalez-Glaria B, Gonzalo-Lazaro M, Apezteguia Iraizoz I, Gutierrez-Valencia M, Rodriguez-Manas L, Izquierdo M. Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):28-36. doi: 10.1001/jamainternmed.2018.4869.
citation: Creditor MC. Hazards of hospitalization of the elderly. Ann Intern Med. 1993 Feb 1;118(3):219-23. doi: 10.7326/0003-4819-118-3-199302010-00011.
citation: Covinsky KE, Pierluissi E, Johnston CB. Hospitalization-associated disability: "She was probably able to ambulate, but I'm not sure". JAMA. 2011 Oct 26;306(16):1782-93. doi: 10.1001/jama.2011.1556.
citation: Loyd C, Markland AD, Zhang Y, Fowler M, Harper S, Wright NC, Carter CS, Buford TW, Smith CH, Kennedy R, Brown CJ. Prevalence of Hospital-Associated Disability in Older Adults: A Meta-analysis. J Am Med Dir Assoc. 2020 Apr;21(4):455-461.e5. doi: 10.1016/j.jamda.2019.09.015. Epub 2019 Nov 14.
citation: Reichardt LA, Aarden JJ, van Seben R, van der Schaaf M, Engelbert RH, Bosch JA, Buurman BM; Hospital-ADL study group. Unravelling the potential mechanisms behind hospitalization-associated disability in older patients; the Hospital-Associated Disability and impact on daily Life (Hospital-ADL) cohort study protocol. BMC Geriatr. 2016 Mar 5;16:59. doi: 10.1186/s12877-016-0232-3.
citation: Hshieh TT, Inouye SK, Oh ES. Delirium in the Elderly. Psychiatr Clin North Am. 2018 Mar;41(1):1-17. doi: 10.1016/j.psc.2017.10.001. Epub 2017 Dec 22.
citation: Bellelli G, Nobili A, Annoni G, Morandi A, Djade CD, Meagher DJ, Maclullich AM, Davis D, Mazzone A, Tettamanti M, Mannucci PM; REPOSI (REgistro POliterapie SIMI) Investigators. Under-detection of delirium and impact of neurocognitive deficits on in-hospital mortality among acute geriatric and medical wards. Eur J Intern Med. 2015 Nov;26(9):696-704. doi: 10.1016/j.ejim.2015.08.006. Epub 2015 Aug 31.
citation: Fortinsky RH, Covinsky KE, Palmer RM, Landefeld CS. Effects of functional status changes before and during hospitalization on nursing home admission of older adults. J Gerontol A Biol Sci Med Sci. 1999 Oct;54(10):M521-6. doi: 10.1093/gerona/54.10.m521.
citation: Sager MA, Franke T, Inouye SK, Landefeld CS, Morgan TM, Rudberg MA, Sebens H, Winograd CH. Functional outcomes of acute medical illness and hospitalization in older persons. Arch Intern Med. 1996 Mar 25;156(6):645-52.
citation: Sager MA, Rudberg MA, Jalaluddin M, Franke T, Inouye SK, Landefeld CS, Siebens H, Winograd CH. Hospital admission risk profile (HARP): identifying older patients at risk for functional decline following acute medical illness and hospitalization. J Am Geriatr Soc. 1996 Mar;44(3):251-7. doi: 10.1111/j.1532-5415.1996.tb00910.x.
citation: Bellelli G, Morandi A, Di Santo SG, Mazzone A, Cherubini A, Mossello E, Bo M, Bianchetti A, Rozzini R, Zanetti E, Musicco M, Ferrari A, Ferrara N, Trabucchi M; Italian Study Group on Delirium (ISGoD). "Delirium Day": a nationwide point prevalence study of delirium in older hospitalized patients using an easy standardized diagnostic tool. BMC Med. 2016 Jul 18;14:106. doi: 10.1186/s12916-016-0649-8.
citation: Lipowski ZJ. Transient cognitive disorders (delirium, acute confusional states) in the elderly. Am J Psychiatry. 1983 Nov;140(11):1426-36. doi: 10.1176/ajp.140.11.1426.
citation: Lindroth H, Bratzke L, Purvis S, Brown R, Coburn M, Mrkobrada M, Chan MTV, Davis DHJ, Pandharipande P, Carlsson CM, Sanders RD. Systematic review of prediction models for delirium in the older adult inpatient. BMJ Open. 2018 Apr 28;8(4):e019223. doi: 10.1136/bmjopen-2017-019223.
citation: Bellelli G, Mazzone A, Morandi A, Latronico N, Perego S, Zazzetta S, Mazzola P, Annoni G. The Effect of an Impaired Arousal on Short- and Long-Term Mortality of Elderly Patients Admitted to an Acute Geriatric Unit. J Am Med Dir Assoc. 2016 Mar 1;17(3):214-9. doi: 10.1016/j.jamda.2015.10.002. Epub 2015 Nov 12.
citation: Geyskens L, Jeuris A, Deschodt M, Van Grootven B, Gielen E, Flamaing J. Patient-related risk factors for in-hospital functional decline in older adults: A systematic review and meta-analysis. Age Ageing. 2022 Feb 2;51(2):afac007. doi: 10.1093/ageing/afac007.
citation: Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
citation: Fisher S, Ottenbacher KJ, Goodwin JS, Graham JE, Ostir GV. Short Physical Performance Battery in hospitalized older adults. Aging Clin Exp Res. 2009 Dec;21(6):445-52. doi: 10.1007/BF03327444.
citation: Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995 Mar 2;332(9):556-61. doi: 10.1056/NEJM199503023320902.
citation: Penninx BW, Ferrucci L, Leveille SG, Rantanen T, Pahor M, Guralnik JM. Lower extremity performance in nondisabled older persons as a predictor of subsequent hospitalization. J Gerontol A Biol Sci Med Sci. 2000 Nov;55(11):M691-7. doi: 10.1093/gerona/55.11.m691.
citation: Miller DK, Wolinsky FD, Andresen EM, Malmstrom TK, Miller JP. Adverse outcomes and correlates of change in the Short Physical Performance Battery over 36 months in the African American health project. J Gerontol A Biol Sci Med Sci. 2008 May;63(5):487-94. doi: 10.1093/gerona/63.5.487.
citation: Pavasini R, Guralnik J, Brown JC, di Bari M, Cesari M, Landi F, Vaes B, Legrand D, Verghese J, Wang C, Stenholm S, Ferrucci L, Lai JC, Bartes AA, Espaulella J, Ferrer M, Lim JY, Ensrud KE, Cawthon P, Turusheva A, Frolova E, Rolland Y, Lauwers V, Corsonello A, Kirk GD, Ferrari R, Volpato S, Campo G. Short Physical Performance Battery and all-cause mortality: systematic review and meta-analysis. BMC Med. 2016 Dec 22;14(1):215. doi: 10.1186/s12916-016-0763-7.
citation: Cooper R, Kuh D, Cooper C, Gale CR, Lawlor DA, Matthews F, Hardy R; FALCon and HALCyon Study Teams. Objective measures of physical capability and subsequent health: a systematic review. Age Ageing. 2011 Jan;40(1):14-23. doi: 10.1093/ageing/afq117. Epub 2010 Sep 15.
citation: Bellelli G, Morandi A, Davis DH, Mazzola P, Turco R, Gentile S, Ryan T, Cash H, Guerini F, Torpilliesi T, Del Santo F, Trabucchi M, Annoni G, MacLullich AM. Validation of the 4AT, a new instrument for rapid delirium screening: a study in 234 hospitalised older people. Age Ageing. 2014 Jul;43(4):496-502. doi: 10.1093/ageing/afu021. Epub 2014 Mar 2.