Validation Study of the "CORNELL ASSESSMENT PEDIATRIC DELIRIUM" (CAPD)" Scale in Italian Language

• Sponsor: Azienda Ospedaliera di Padova (Other)
• Overall Status: Completed
• CT.gov ID: NCT04589767
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Actual Duration (Months): 21
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

70 children (based on the inclusion and exclusion criteria described above) admitted in PICU will be daily assessed by two nurses (inter-evaluator agreement) using the Italian version of CAPD scale administered twice at a distance of 2 minutes (intra-evaluator agreement).

Condition or Disease	Intervention/Treatment	Phase
Delirium	Behavioral: CAPD scale

Detailed Description

The psychometric validation study will take place in the PICU of the Hospital of Padua. CAPD translation and cultural adaptation was developed within the Pediatric Cardiac Surgery Intensive Care Unit of the Federico II Polyclinic.

In this study we aim to perform the psychometric validation. 70 children (based on the inclusion and exclusion criteria described above) admitted in PICU will be daily assessed by two nurses (inter-evaluator agreement) using the Italian version of CAPD scale administered twice at a distance of 2 minutes (intra-evaluator agreement).

The score will be recorded in a data collection card, all the cards will be collected and then analyzed.

Study Design

• Study Type: Observational
• Actual Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Validation Study of the "CORNELL ASSESSMENT PEDIATRIC DELIRIUM" (CAPD)" Scale in Italian Language
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Aug 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
children admitted in PICU children enrolled will be evaluated by two nurses using CAPD Italian version. One nurse will repeat the evaluation two minutes later.	Behavioral: CAPD scale; Two nurses will apply CAPD scale. One nurse will repeat the CAPD evaluation two minutes later

Outcome Measures

Primary Outcome Measures

1. inter-evaluator agreement [1 hour during PICU stay]

   CAPD evaluation by two operators

2. intra-evaluator agreement [2 minutes during PICU stay]

   CAPD evaluation by two operators

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• PICU admission

• Comfort Behavioral Score > 11

Exclusion Criteria:

• use of neuromuscular blocking agents at the moment of CAPD evaluation

• Comfort Behavioral Score < 11

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PICU University Hospital of Padova	Padova		Italy

Sponsors and Collaborators

• Azienda Ospedaliera di Padova

Investigators

• Principal Investigator: angela amigoni, University Hospital Padova

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: angela amigoni, MD, Azienda Ospedaliera di Padova
• ClinicalTrials.gov Identifier: NCT04589767
• Other Study ID Numbers: 4792/AO/19
• First Posted: Oct 19, 2020
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by angela amigoni, MD, Azienda Ospedaliera di Padova: delirium; monitoring
• Additional relevant MeSH terms: Delirium

Study Results

No Results Posted as of Mar 2, 2022