Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690672
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2022-09-26
Brief Title:
Screening for Delirium in Older Inpatients
Sponsor:
Aalborg University Hospital
Organization:
Aalborg University Hospital
Study Overview
Official Title:
Screening for Delirium in Older Inpatients Using 3D-CAM and 4AT Protocol for a Randomized Pilot Study
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Two-arm parallel-randomized pilot study and to collect data at the Department of Geriatric Medicine at Aalborg University Hospital The aim is to assess the feasibility of a future randomized controlled study comparing Danish versions of 3D-CAM and 4AT in an acute medical setting The primary objective is to assess 1 feasibility of obtaining informed consent and recruiting older adults within 24 hours of admission or surgery at the Department of Geriatric Medicine Department of Acute Medicine or Department of Orthopedic Surgery Secondary objectives are 2a to compare feasibility of recruitment and testing in the three different departments 2b to inform a preliminary evaluation of validity and reliability of the Danish version of screening instruments and 2c to obtain data on variance to support calculating sample size for a full-scale RCT
Detailed Description:
We will recruit participants through a consecutive sampling of all potentially eligible patients Recruitment will take place in three different settings the Department of Geriatric Medicine the Department of Acute Medicine and the Department of Orthopedic Surgery One week will be allocated for recruitment in each setting
Potentially delirious patients often have impaired cognitive status Therefore the process of recruitment and informed consent is critically important and poses a central issue of feasibility to be assessed in this study
It cannot be known with certainty whether patients are delirious prior to inclusion into the study and even among delirious patients there are considerable circadian fluctuations as this is a hallmark of the condition meaning that patients may have lucid moments during the day where they are cognitively intact and may be able to give informed consent
Generally informed consent will be sought from participants when possible In case they are permanently or temporarily unable to give informed consent informed consent will be sought from next of kin Due to the short time in the study for each participant it is not anticipated that participants will regain the ability to give informed consent during the study However if they do new informed consent will be obtained from the participant The number of potential participants at each step will be documented to assess problems with feasibility
Potentially delirious patients often have impaired cognitive status Therefore the process of recruitment and informed consent is critically important and poses a central issue of feasibility to be assessed in this study
It cannot be known with certainty whether patients are delirious prior to inclusion into the study and even among delirious patients there are considerable circadian fluctuations as this is a hallmark of the condition meaning that patients may have lucid moments during the day where they are cognitively intact and may be able to give informed consent
Generally informed consent will be sought from participants when possible In case they are permanently or temporarily unable to give informed consent informed consent will be sought from next of kin Due to the short time in the study for each participant it is not anticipated that participants will regain the ability to give informed consent during the study However if they do new informed consent will be obtained from the participant The number of potential participants at each step will be documented to assess problems with feasibility
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None