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Screening for Delirium in Older Inpatients

Primary Purpose

Delirium in Old Age

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Delirium Screening
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Delirium in Old Age

Eligibility Criteria

80 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age over 80 years Admission or surgery within the last 24 hours Exclusion Criteria: Unable to obtain contact to next of kin for informed consent within time-frame

Sites / Locations

  • Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

3D-CAM screening

4AT screening

Arm Description

Outcomes

Primary Outcome Measures

Feasibility of recruitment overall
Measured by counting the number of participants giving informed consent, as well as number of participants in each setting not giving informed consent in each setting over the 3 week period.

Secondary Outcome Measures

Feasibility of recruitment in different settings
Comparison of the number of participants (counted) recruited in the Department of Orthopedic Surgery, Geriatric Medicine and Acute Medicine
Validity of screening tools
Preliminary results of screening validity of 4A's test and 3D-CAM test comparing sensitivity and specificity

Full Information

First Posted
September 26, 2022
Last Updated
August 11, 2023
Sponsor
Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05690672
Brief Title
Screening for Delirium in Older Inpatients
Official Title
Screening for Delirium in Older Inpatients Using 3D-CAM and 4AT: Protocol for a Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 28, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium in Old Age

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3D-CAM screening
Arm Type
Active Comparator
Arm Title
4AT screening
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Delirium Screening
Intervention Description
Either 3D-CAM or 4AT
Primary Outcome Measure Information:
Title
Feasibility of recruitment overall
Description
Measured by counting the number of participants giving informed consent, as well as number of participants in each setting not giving informed consent in each setting over the 3 week period.
Time Frame
3 weeks total
Secondary Outcome Measure Information:
Title
Feasibility of recruitment in different settings
Description
Comparison of the number of participants (counted) recruited in the Department of Orthopedic Surgery, Geriatric Medicine and Acute Medicine
Time Frame
1 week each
Title
Validity of screening tools
Description
Preliminary results of screening validity of 4A's test and 3D-CAM test comparing sensitivity and specificity
Time Frame
3 weeks total

10. Eligibility

Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 80 years Admission or surgery within the last 24 hours Exclusion Criteria: Unable to obtain contact to next of kin for informed consent within time-frame
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
State/Province
Northern Jutland
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

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Screening for Delirium in Older Inpatients

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