Italian Validation of the Beaumont Behavioural Inventory (BBI)
BBI
Validazione Italiana Dello Strumento BBI (Beaumont Behavioural Inventory) Per la Valutazione Delle Alterazioni Comportamentali Nel Paziente Affetto da Malattia Del Motoneurone
1 other identifier
observational
190
1 country
1
Brief Summary
Up to 50% of patients affected with amyotrophic lateral sclerosis (ALS) can show behavioral dysfunctions within the spectrum of frontotemporal degenerations (FTD) - namely, apathy, disinhibition, loss of sympathy/empathy, perseverative and stereotyped behaviours, dietary changes \[Strong et al., 2017\]. The Beaumont Behavioural Inventory (BBI) \[Elamin et al., 2017\] is a questionnaire designed for detecting FTD-spectrum behavioural changes in ALS patients. The present study aims at both validating the BBI in an Italian ALS population and determining normative cut-off values of the instrument.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2019
CompletedFirst Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
June 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedOctober 22, 2021
October 1, 2021
1 year
June 18, 2020
October 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Beaumont Behavioural Inventory
Psychometrics
2 years
Study Arms (2)
Patients
patients with amyotrophic lateral sclerosis
Healthy control
healthy control participants
Interventions
Eligibility Criteria
Subject with amyotrophic lateral sclerosis
You may qualify if:
- possible, probable or definite ALS according to El Escorial revised criteria
You may not qualify if:
- Any other clinically significant cardiovascular, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator could interfere with the interpretation of the study results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICS Maugeri
Milan, 20138, Italy
Related Publications (1)
Iazzolino B, Pain D, Laura P, Aiello EN, Gallucci M, Radici A, Palumbo F, Canosa A, Moglia C, Calvo A, Mora G, Chio A. Italian adaptation of the Beaumont Behavioral Inventory (BBI): psychometric properties and clinical usability. Amyotroph Lateral Scler Frontotemporal Degener. 2022 Feb;23(1-2):81-86. doi: 10.1080/21678421.2021.1946085. Epub 2021 Jul 19.
PMID: 34279169RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2020
First Posted
June 19, 2020
Study Start
September 17, 2019
Primary Completion
September 30, 2020
Study Completion
November 30, 2020
Last Updated
October 22, 2021
Record last verified: 2021-10