NCT05690672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

September 28, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

September 26, 2022

Last Update Submit

August 11, 2023

Conditions

Delirium in Old Age

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 weeks total

Secondary Outcomes (2)

  • Feasibility of recruitment in different settings

    1 week each

  • Validity of screening tools

    3 weeks total

Study Arms (2)

3D-CAM screening

ACTIVE COMPARATOR
Diagnostic Test: Delirium Screening

4AT screening

ACTIVE COMPARATOR
Diagnostic Test: Delirium Screening

Interventions

Delirium ScreeningDIAGNOSTIC_TEST

Either 3D-CAM or 4AT

3D-CAM screening4AT screening

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age over 80 years
  • Admission or surgery within the last 24 hours

You may not qualify if:

  • Unable to obtain contact to next of kin for informed consent within time-frame

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, Northern Jutland, 9000, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2022

First Posted

January 19, 2023

Study Start

September 28, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

DK(1)