NCT05836714

Brief Summary

Despite the presence of validated tests, there are still drawbacks to implementing delirium diagnosis tests in hospital wards. We developed a new, simple, easy to implement user friendly delirium diagnostic test that is likely to facilitate implementation in many departments. The present study will compare the new test to a well validated older test - 4AT.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
365

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

April 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

April 19, 2023

Last Update Submit

April 28, 2023

Conditions

Keywords

DELIRIUMDIAGNOSIS4AT

Outcome Measures

Primary Outcomes (1)

  • Validation of a viable delirium detection test care.

    non-inferiority of a new delirium detection test (R\&M) compared to 4AT.

    ONE YEAR

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients \>70 yrs old, hospitalized in the department of internal medicine

You may qualify if:

  • \- patients \>70 yrs old, hospitalized in the department of internal medicine

You may not qualify if:

  • severe dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai-Zion Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

DeliriumDisease

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersPathologic Processes

Study Officials

  • RON OLIVEN, MD

    BNAI-ZION MC HAIFA ISRAEL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 1, 2023

Study Start

May 1, 2023

Primary Completion

June 1, 2023

Study Completion

May 31, 2024

Last Updated

May 1, 2023

Record last verified: 2023-04

Locations