Delirium in Old Age Clinical Trial
Official title:
Screening for Delirium in Older Inpatients Using 3D-CAM and 4AT: Protocol for a Randomized Pilot Study
Verified date | August 2023 |
Source | Aalborg University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 80 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University Hospital | Aalborg | Northern Jutland |
Lead Sponsor | Collaborator |
---|---|
Aalborg University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 1 week each | |
Secondary | Validity of screening tools | Preliminary results of screening validity of 4A's test and 3D-CAM test comparing sensitivity and specificity | 3 weeks total |
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