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Global Approach to Faint and Falls

NCT05752682 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 340

Last updated 2023-03-15

No results posted yet for this study

Summary

Syncope is the most frequent cause of transient loss of consciousness. Falls are very common in older people. If the falls are unexplained and not accidental, it is likely that the patient had a syncope event and showed a lack of awareness for loss of consciousness. The management of unexplained falls is the same as that of syncope. There is a gap between the best available scientific evidence provided by the guidelines and the need to disseminate these concepts in clinical practice. The absence of a systematic comprehensive approach to fainting and falls results in higher health and social costs, unnecessary hospitalizations and diagnostic procedures, prolonged hospital stays, lower diagnostic rates, and higher rates of misdiagnosis and symptomatic recurrence.

Aim of the study The aim of the study is to assess the efficacy (adherence) of a diagnostic protocol and the costs of a comprehensive guideline-based approach to the management of fainting and falls in a population of consecutive patients referred to a dedicated multidisciplinary outpatient facility.

Primary endpoint:

1\. Prevalence rate of patients with unexplained fall undergoing diagnostic investigations for syncope among those initially subjected to a diagnostic evaluation for falls.

Secondary endpoints:

1. Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of diagnostic tests and final diagnosis.
2. Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of adherence to guideline recommendations.
3. Analysis of costs per patient of fall and syncope protocols
4. All previous analyses will be performed according to the following age groups: ≥75, 74-65 and 64-40 years.

Inclusion criteria

1. Consecutive patients \>40 years of age, belonging to the Cwithin Fainting and Falls for the evaluation of an episode of syncope or fall.
2. Fragile patients at risk of falling.

Exclusion criteria:

1. Patients aged \<40 years
2. Patients with dental falls
3. Patients with a known diagnosis of syncope
4. Patients in whom syncope and fall are secondary symptoms of severe underlying comorbidities

Conditions

  • Syncope
  • Fall

Interventions

DIAGNOSTIC_TEST

Diagnostic pathway

Each included patient will undergo to the faint and fall protocol, to assess the effectiveness of a patients' flow pathways developed in accordance with the most recent guidelines on syncope of the European Society of cardiology and of guidelines on falls of the American and British Geriatrics Societies.

Sponsors & Collaborators

  • Istituto Auxologico Italiano

    lead OTHER

Principal Investigators

  • Michele Brignole · Istituto Auxologico Italiano

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05752682 on ClinicalTrials.gov