Prevention study for Frailty Syndrome
Official title Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions
ClinicalTrials.gov ID: NCT06611228
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join 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...
- Ability to walk with or without assistance
- Ability to communicate and cooperate with the research team;
- Ability to sign informed consent.
You likely can't join 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);
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Monza, Lumbardy, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Monza, Lumbardy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.