Global Approach to Faint and Falls

NCT05752682 | Recruiting

• 1 other identifier: 09C021
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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. 1.Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of diagnostic tests and final diagnosis.
2. 2.Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of adherence to guideline recommendations.
3. 3.Analysis of costs per patient of fall and syncope protocols
4. 4.All previous analyses will be performed according to the following age groups: ≥75, 74-65 and 64-40 years.
5. 5.Consecutive patients \>40 years of age, belonging to the Cwithin Fainting and Falls for the evaluation of an episode of syncope or fall.
6. 6.Fragile patients at risk of falling.
7. 7.Patients aged \<40 years
8. 8.Patients with dental falls
9. 9.Patients with a known diagnosis of syncope
10. 10.Patients in whom syncope and fall are secondary symptoms of severe underlying comorbidities

Conditions

Syncope; Fall

Keywords

Syncope; Fall; Tilt table test; Ambulatory blood pressure monitoring; carotid sinus massage; implantable loop recorder; Treatment; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Unexplained falls

  Point and interval prevalence estimation of patients with unexplained falls, among those who underwent fall diagnostic assessment at initial presentation and then moved to faint pathway for prosecution of diagnostic assessment and its determinants.

  1 year

Secondary Outcomes (3)

• Final diagnosis

  1 year

• Comparison

  1 year

• Costs

  1 year

Study Arms (1)

Syncope and fall

Consecutive patients aged ≥40 years referred to the Faint \& Fall Clinics for assessment of an episode of faint or fall.

Diagnostic Test: Diagnostic pathway

Interventions

Diagnostic pathway DIAGNOSTIC_TEST

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.

Syncope and fall

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with faint or fall referred to a Syncope Unit for diagnosis and therapy

You may qualify if:

• Consecutive patients aged ≥40 years referred to the Faint \& Fall Clinics for assessment of an episode of faint or fall.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

IRCCS Istituto Auxologico Italiano

Milan, MI, 16149, Italy

RECRUITING

Related Publications (2)

• Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available.

  PMID: 29562304 BACKGROUND

• Panel on Prevention of Falls in Older Persons, American Geriatrics Society and British Geriatrics Society. Summary of the Updated American Geriatrics Society/British Geriatrics Society clinical practice guideline for prevention of falls in older persons. J Am Geriatr Soc. 2011 Jan;59(1):148-57. doi: 10.1111/j.1532-5415.2010.03234.x.

  PMID: 21226685 BACKGROUND

MeSH Terms

Conditions

Syncope; Disease

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Michele Brignole

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Brignole

CONTACT

+393204391422; mbrignole@outlook.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 3, 2023
• Study Start: March 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)