Validation Study of the Speedy Meyer Fall Scale for Determining the Fall Risk of the Paediatric Patient

Fall Prevention Clinical Trial

Official title:

Validation Study of the Speedy Meyer Fall Scale for Determining the Fall Risk of the Paediatric Patient

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311409
• Other study ID #: SMFS2019
• Status: Recruiting
• Start date: January 29, 2020
• Est. completion date: April 2024

Study information

• Verified date: February 2024
• Source: Meyer Children's Hospital IRCCS
• Contact: Daniele Ciofi
• Phone: 0555662496
• Email: daniele.ciofi[@]meyer.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Fall prevention is an essential element in ensuring safe care for paediatric patients. The first step in building a risk reduction programme is the adoption of an assessment tool to identify those most at risk at an early stage. From October 2014 to date, a study has been conducted for the linguistic-cultural validation of the Humpty Dumpty Fall Scale (HDFS) in the Italian context, through a multicentre survey with the help of the Clinical Risk Management Group of the Region of Tuscany. The objective of this study is the validation of the new Humpty Dumpty Fall Scale defined as Speedy Meyer-Fall Scale (SMFS) by assessing the comprehension and validity of the scale and items via Content Validity Index (SCVI and ICVI) estimation of inter-item reliability (Crombach's alpha), inter-rater reliability (Cohen's K), sensitivity, specificity, PPV, NPV and ROC curve.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 332
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

Inclusion Criteria:

• children admitted as in-patients for whom the parents have given consent to the study, aged between 12 months and 16 years, of any gender, pathology and reason for admission.

Exclusion Criteria:

• not signed consent form

Related Conditions & MeSH terms

• Fall Prevention

Locations

Country	Name	City	State
Italy	AUSL Toscana Sud Est	Arezzo
Italy	Meyer Children's Hospital IRCCS	Florence
Italy	Fondazione Gabriele monasterio - Ospedale Pediatrico Apuano Massa	Massa

Sponsors (1)

Lead Sponsor	Collaborator
Meyer Children's Hospital IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	validation of the SMFS t	validation of the SMFS through the assessment of the comprehensibility of the SMFS, the validity of the SMFS through Content Validity Index at item (ICVI) and scale (SCVI) level, and the reliability of the SMFS through inter-item reliability (Cronbach's alpha) and Inter-rater Reliability (Cohen's K)	through study completion, an average of 1 year
Secondary	identification of patients high risk of falls	estimation of the sensitivity, specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV) and ROC curve in clinical practice and their comparison with the theoretical data of the scale in question in order to identify patients at high risk of falls in a paediatric hospital	through study completion, an average of 1 year