Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT07114458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Delirium and Cognitive Impairment Development in Hospitalized Older Adults Under Isolation Conditions
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Study Overview
Official Title:
Delirium Incidence and Cognitive Trajectories in Isolated Older Patients in the Inpatient Setting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DELiso
Brief Summary:
The goal of this observational study is to examine if older patients who need to be under isolation precautions due to multidrug resistant bacteria or other reasons have an increased risk of suffering from delirium or cognitive decline compared to older patients without isolation precautions.
To compare this, every person under isolation precautions is compared to other persons of the same age, gender, comorbidities, frailty status and hospital department. Delirium is assessed twice daily with a screening tool named 3D-CAM and cognitive performance is tested by the MOCA-Test six weeks after discharge from hospital and compared to baseline values which are assessed directly after study enrollment.
The study duration for each patient participating is from the time of enrollment during hospitalization until 6 weeks after hospital discharge.
To compare this, every person under isolation precautions is compared to other persons of the same age, gender, comorbidities, frailty status and hospital department. Delirium is assessed twice daily with a screening tool named 3D-CAM and cognitive performance is tested by the MOCA-Test six weeks after discharge from hospital and compared to baseline values which are assessed directly after study enrollment.
The study duration for each patient participating is from the time of enrollment during hospitalization until 6 weeks after hospital discharge.
Detailed Description:
Delirium is a common complication in older patients during hospitalization. Its prevention is crucial, as it increases morbidity, mortality, and cognitive impairment. Isolation precautions in hospital may further increase delirium risk due to sensory deprivation and reduced mobility.
This study examines the impact of isolation precautions on delirium and neurocognitive disorders in patients ≥70 years. Delirium screening will occur twice daily, with a six-week post-discharge follow-up.
A prospective cohort study will compare delirium incidence in isolated patients with a matched non-isolated control group (matched for age, gender, Charlson Comorbidity Index, Frailty and hospital department). The 3D Confusion Assessment Method (3D-CAM) will be used for Delirium screening. Follow-up assessments will evaluate cognitive function and quality of life. Data will be collected during hospitalization (Days 1-5) and six weeks post-discharge.
This study examines the impact of isolation precautions on delirium and neurocognitive disorders in patients ≥70 years. Delirium screening will occur twice daily, with a six-week post-discharge follow-up.
A prospective cohort study will compare delirium incidence in isolated patients with a matched non-isolated control group (matched for age, gender, Charlson Comorbidity Index, Frailty and hospital department). The 3D Confusion Assessment Method (3D-CAM) will be used for Delirium screening. Follow-up assessments will evaluate cognitive function and quality of life. Data will be collected during hospitalization (Days 1-5) and six weeks post-discharge.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: