Search / Trial NCT06611228

Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions

Launched by UNIVERSITY OF MILANO BICOCCA · Sep 20, 2024

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Trial Information

Current as of December 31, 2024

Not yet recruiting

Keywords

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

ClinConnect Summary

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...

Gender

ALL

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.

Trial Officials

Giuseppe Bellelli, MD

Principal Investigator

Università di Milano-Bicocca

Giuseppe Bellelli, MD

Study Chair

Università di Milano-Bicocca

About University Of Milano Bicocca

The University of Milano-Bicocca is a distinguished academic institution renowned for its commitment to advancing research and education in the biomedical sciences. With a strong emphasis on interdisciplinary collaboration, the university fosters innovative clinical trials that aim to enhance patient care and medical outcomes. Its research initiatives are supported by state-of-the-art facilities and a dedicated team of experts, positioning the University of Milano-Bicocca as a leading sponsor in the realm of clinical trials, dedicated to translating scientific discoveries into practical applications for the benefit of society.

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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