Validation Study of the Speedy Meyer Fall Scale for Determining the Fall Risk of the Paediatric Patient
1 other identifier
observational
332
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 29, 2020
CompletedFirst Submitted
Initial submission to the registry
February 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedFirst Posted
Study publicly available on registry
March 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedMarch 15, 2024
February 1, 2024
4.1 years
February 23, 2024
March 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
identification of patients high risk of falls
through study completion, an average of 1 year
Eligibility 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. Population i
You may qualify if:
- 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.
You may not qualify if:
- not signed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
AUSL Toscana Sud Est
Arezzo, 51100, Italy
Meyer Children's Hospital IRCCS
Florence, Italy
Fondazione Gabriele monasterio - Ospedale Pediatrico Apuano Massa
Massa, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Daniele Ciofi
Meyer Children's Hospital IRCCS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Princiapl Investigator
Study Record Dates
First Submitted
February 23, 2024
First Posted
March 15, 2024
Study Start
January 29, 2020
Primary Completion
March 1, 2024
Study Completion
April 1, 2024
Last Updated
March 15, 2024
Record last verified: 2024-02