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

Recruiting

• Conditions: Fall Prevention

• Registration Number: NCT06311409
• Lead Sponsor: Meyer Children's Hospital IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-29
• Status Verified: 2024-02
• Study First Submitted: 2024-02-23
• Primary Completion: 2024-03
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 332

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
validation of the SMFS t	through study completion, an average of 1 year	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)

Secondary Outcome Measures

Name	Time	Method
identification of patients high risk of falls	through study completion, an average of 1 year	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

Trial Locations

Locations (3)

Fondazione Gabriele monasterio - Ospedale Pediatrico Apuano Massa; 🇮🇹 Massa, Italy

AUSL Toscana Sud Est; 🇮🇹 Arezzo, Italy

Meyer Children's Hospital IRCCS; 🇮🇹 Florence, Italy