Delirium and Cognitive Impairment Development in Hospitalized Older Adults Under Isolation Conditions

Not yet recruiting

• Conditions: Delirium; Dementia; Cognitive Impairment

• Registration Number: NCT07114458
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

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.

Study Timeline

• Study First Submitted: 2025-03-16
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-03
• Last Update Submitted: 2025-08-03
• Study Start: 2025-08-05
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2027-04
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 404

Inclusion Criteria

• hospitalized patients

• under isolation precautions for at least 24h
• 70 years and above

Exclusion Criteria

• no informed consent

• intensive care treatment
• life expectancy 14 days or less

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delirium	day 1-5 under isolation precautions	Delirium screened by 3D-Confusion Assessment Method 2 times daily

Secondary Outcome Measures

Name	Time	Method
Cognitive performance	at enrollment and six weeks after discharge from hospital	Measures by Montreal Cognitive Assessment (MOCA). Maximum 15, minimum 0 points. Higher points indicate less functional impairment.
Functional state	at enrollment and six weeks after discharge from hospital	Daily activities and functionality assessed by WHO Disability Assessment Schedule (WHODAS 2.0), a questionnaire with 36-items; answers are on a 5-step-Likert-scale; when values are summed up, higher values indicate a worse functional state
Quality-of-Life (QoL)	at enrollment and 6 weeks after discharge from hospital	QoL assessed by Visual Analogue Scale from EQ-5D-5L questionnaire (no abbreviation); Maximum 100 points, minimum 0 points; more points indicate a better QoL.