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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06311409

Enrollment

332

Registered

2024-03-15

Start date

2020-01-29

Completion date

2024-04-30

Last updated

2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall Prevention

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactDaniele Ciofi

daniele.ciofi@meyer.it0555662496

Outcome results