Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions

NCT06611228 | Recruiting DMC

• 1 other identifier: OPTIMAge-IT
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty Syndrome; Aging

Keywords

Hospital Acquired Disability; Frailty Syndrome; Comprehensive Geriatric Assessment; Prevention; Integrated Multidomain Interventions; Telemedicine; Telemonitoring; Outcomes; Hospital

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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)

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

Secondary Outcomes (17)

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

  6 months

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

  3 months

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

  3 months, 6 months

• 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 mortality at follow-up.

  3 months, 6 months

Other Outcomes (15)

• Assess the impact of the MDI on cardiovascular risk factors.

  Baseline, 6 months

• Evaluate the effect of the MDI on participants' social relationships.

  3 months, 6 months

• Evaluate the impact of fortified food consumption on microbiota composition and bowel alterations in a subgroup of patients not undergoing antibiotic therapy (ancillary study).

  Baseline, Through Discharge an Average of 10 days

Study Arms (2)

Intervention Group

EXPERIMENTAL

The interventions include: * Physical Exercise: Tailored sessions with the VIVIFRAIL exercise protocol, monitored with accelerometers, and supported by a physical activity kit. * Nutrition: Mediterranean diet with education on nutrient balance and avoiding ultra-processed foods. * Health \& Sleep: Promotion of healthy habits, fall prevention, sleep hygiene, and targeted sleep disorder treatments. * Polypharmacotherapy: Review and adjustment of medications as needed. * Cognition: Cognitive rehabilitation using technology and educational videos. * Environment: Adjustments to create an "older-friendly" Acute Unit, including modified routines and extended visiting hours.

Other: Multidomain Interventions

Control Group

NO INTERVENTION

Centers randomized to the control group will follow usual care protocols. However, all participants in this group will receive standardized leaflets at discharge, providing physical, nutritional, and behavioral advice.

Interventions

Multidomain Interventions OTHER

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

Intervention Group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lumbardy, 20900, Italy

RECRUITING

Related Publications (36)

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Related Links

• Organization WH. World report on ageing and health \[Internet\]. Geneva PP - Geneva: World Health Organization
• Organization WH. Integrated care for older people: guidelines on community-level interventions to manage declines in intrinsic capacity \[Internet\]. Geneva PP - Geneva: World Health Organization;

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Bellelli, MD

  Università di Milano-Bicocca

  PRINCIPAL INVESTIGATOR

• Giuseppe Bellelli, MD

  Università di Milano-Bicocca

  STUDY CHAIR

Central Study Contacts

Giuseppe Bellelli, MD

CONTACT

3392777327; giuseppe.bellelli@campus.unimib.it

Giuseppe Bellelli, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, randomized controlled (parallel-arm cluster), non-drug interventional clinical study

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 24, 2024
• Study Start: December 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)