Assessing a comprehensive approach to managing fainting and falls
Guideline-based Global Approach to the Management of Faints and Falls in a Dedicated Outpatient Facility
This study is testing a new way to help people aged 40 and older who faint or fall for no clear reason to see if it can improve their diagnosis and reduce hospital visits.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 340 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT05752682 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a guideline-based diagnostic protocol for managing patients with unexplained fainting and falls. It focuses on patients aged 40 and older who are referred to specialized clinics for assessment. The study aims to identify the prevalence of unexplained falls and improve diagnostic accuracy through a systematic approach. By analyzing patient flow and adherence to the protocol, the study seeks to reduce unnecessary hospitalizations and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40 and older who have experienced unexplained fainting or falls.
Not a fit: Patients under 40, those with incidental falls, or those with established diagnoses of syncope will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of fainting and falls, reducing health costs and improving patient safety.
How similar studies have performed: Other studies have shown that structured diagnostic pathways can improve outcomes in similar patient populations, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consecutive patients aged ≥40 years referred to the Faint \& Fall Clinics for assessment of an episode of faint or fall. Exclusion Criteria: * Patients with age \<40 years * Patients with incidental fall * Patients with an established diagnosis of syncope * Patients in whom syncope and fall are secondary symptoms of severe underlying comorbidities (e.g: acute myocardial infarction, pulmonary embolism, acute haemorrage)
Where this trial is running
Milan, MI
- IRCCS Istituto Auxologico Italiano — Milan, Mi, Italy (Recruiting)
Study contacts
- Principal investigator: Michele Brignole — Istituto Auxologico Italiano
- Study coordinator: Michele Brignole
- Email: mbrignole@outlook.it
- Phone: +393204391422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.