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NCT Number: NCT06611228

Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions

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.

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Key information

Conditions

Frailty Syndrome Aging Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lumbardy, 20900, Italy

Location status: Recruiting

Location contact

Chukwuma Okoye, MD

CONTACT

[email protected]

003902223970

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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)

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

Secondary outcomes

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

    Time frame: 6 months

    Effect of the MDI in reducing hospital readmissions at 6 months

  2. Evaluate the participant adherence to the protocol

    Time frame: 6 months

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

  3. Evaluate the feasibility of home-based MDI with technological support

    Time frame: 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

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

    Time frame: 3 months

    Effect of the MDI in reducing hospital readmissions at 3 months

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

    Time frame: 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).

  6. 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 in-hospital mortality

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

    Time frame: 3 months, 6 months

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

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

    Time frame: 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)

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

    Time frame: 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)

  10. 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

    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

  11. 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

    Effect of the MDI in reducing the incidence of in-hospital complications as sepsis, urinary infections, blood infections, and pressure ulcers.

  12. 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

    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).

  13. Assess the effect of the MDI on the incidence of delirium during hospitalization

    Time frame: 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)

  14. Assess the effect of the MDI on cognitive performance at follow-up.

    Time frame: 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)

  15. Assess the effect of the MDI on functional performance at follow-up

    Time frame: 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)

  16. Assess the effect of the MDI on motor performance at follow-up.

    Time frame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months

    Assessed using SPPB (0-12), hand grip strength (Kg)

  17. Assess the acceptability of technological solutions during hospitalization and at follow-up.

    Time frame: Discharge (after an average hospital stay of 10 days), 3 months, and 6 months

    Acceptability of technological solutions through the administration of specific questionnaires

  18. Evaluate the cost impact of the MDI on the healthcare system.

    Time frame: 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

  19. Evaluate the effect of the MDI on the length of hospital stay.

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

    Effect of the MDI in reducing the length of hospital stay

Other outcomes

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

    Time frame: Baseline, 6 months

    Impact of MDI on lifestyle and inactivity, blood pressure, smoking, cholesterol level, and blood glucose.

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

    Time frame: 3 months, 6 months

    Effect of the MDI on improving social relationships, assessed using the Lubben Social Network Scale (12 items scale)

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

    Time frame: Baseline, Through Discharge an Average of 10 days

    Evaluation of the impact of fortified food consumption on faecal analysis in a subgroup of patients not undergoing antibiotic therapy

  4. Assess participants access to (and frequency of use of) technological resources.

    Time frame: Through Discharge an Average of 10 days, 3 months

    Number of app accesses.

  5. Assess the effect of the MDI on mood of participants

    Time frame: Baseline, 3 months, 6 months

    Effect of the MDI on mood, assessed using the Geriatric Depression Scale (GDS, 0-30)

  6. Evaluate the effect of the MDI on biomarkers of aging

    Time frame: Baseline, 6 months

    Changes on the Free Triiodothyronine/Free Thyroxine (FT3/FT4) concentration in the MDI group compared to controls

  7. Evaluate the effect of the MDI on biomarkers of aging

    Time frame: Baseline

    Effect of the MDI on partipants according to Serum Amyloid Beta (Aβ) concentration categories

  8. Evaluate the effect of the MDI on biomarkers of aging

    Time frame: Baseline

    Effect of the MDI on partipants according to their Serum Phosphorylated Tau at Threonine 181 (p-tau181), p-tau217, p-tau231 concentrations

  9. Evaluate the effect of the MDI on biomarkers of aging

    Time frame: Baseline, 6 months

    Changes on high-sensitivity C-reactive protein (hs-CRP, measured in mg/L) concentration of the MDI group compared to controls

  10. Evaluate the effect of the MDI on biomarkers of aging

    Time frame: Baseline, 6 months

    Changes on Erythrocyte sedimentation rate (ESR, measured in mm/h) of the MDI group compared to controls

  11. Evaluate the effect of the MDI on biomarkers of aging

    Time frame: Baseline, 6 months

    Changes on interleukin 6 (IL-6, measured in pg/mL) concentration of the MDI group compared to controls

  12. Evaluate the effect of the MDI on biomarkers of aging

    Time frame: Baseline, 6 months

    Changes on the Neurofilament Light Chain (NF-L, measured in pg/mL) concentration in the MDI group compared to controls

  13. Evaluate the effect of the MDI on biomarkers of aging

    Time frame: Baseline, 6 months

    Changes on the Soluble Receptor for Advanced Glycation End-products (s-RAGE, measured in ng/mL) concentration in the MDI group compared to controls

  14. Evaluate the effect of the MDI on biomarkers of aging

    Time frame: Baseline, 6 months

    Changes on the Fibroblast Growth Factor 1 concentration (FGF-1, measured in pg/mL) in the MDI group compared to controls

  15. Evaluate the effect of the MDI on biomarkers of aging

    Time frame: Baseline, 6 months

    Changes on the Growth Differentiation Factor 15 concentration (GDF-15, measured in pg/mL), in the MDI group compared to controls.

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Bellelli, MD

CONTACT

[email protected]

3392777327

Giuseppe Bellelli, MD

CONTACT

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Official study title

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

Acronym: OPTIMAge-IT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 24, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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