Skip to main content
OpenTrials
Completed

NCT Number: NCT05690672

Screening for Delirium in Older Inpatients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Delirium in Old Age

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital

Aalborg, Northern Jutland, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delirium Screening

Diagnostic Test

Either 3D-CAM or 4AT

Primary outcomes

  1. Feasibility of recruitment overall

    Time frame: 3 weeks total

    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 outcomes

  1. Feasibility of recruitment in different settings

    Time frame: 1 week each

    Comparison of the number of participants (counted) recruited in the Department of Orthopedic Surgery, Geriatric Medicine and Acute Medicine

  2. Validity of screening tools

    Time frame: 3 weeks total

    Preliminary results of screening validity of 4A's test and 3D-CAM test comparing sensitivity and specificity

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

Screening for Delirium in Older Inpatients Using 3D-CAM and 4AT: Protocol for a Randomized Pilot Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 19, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.