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

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.

Study Overview

• Status: Recruiting
• Conditions: Fall Prevention

• Study Type: Observational
• Enrollment (Estimated): 332

Contacts and Locations

• Study Contact: Name: Daniele Ciofi; Phone Number: 0555662496; Email: daniele.ciofi@meyer.it

Study Locations

• Italy
  • Arezzo, Italy, 51100
    • Not yet recruiting
    • AUSL Toscana Sud Est
  • Florence, Italy
    • Recruiting
    • Meyer Children's Hospital IRCCS
    • Contact: Daniele Ciofi; Email: daniele.ciofi@meyer.it
  • Massa, Italy
    • Not yet recruiting
    • Fondazione Gabriele monasterio - Ospedale Pediatrico Apuano Massa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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. Population i

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS
• Investigators: Principal Investigator: Daniele Ciofi, Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SMFS2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No