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

NCT ID: NCT07114458

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 404 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2027-11-30

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.

Conditions

Delirium; Dementia; Cognitive Impairment

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Exposition

Patients under isolation precautions in hospital

No interventions assigned to this group

Control

Matched control, no isolation precautions

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• intensive care treatment
• life expectancy 14 days or less

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia Olotu, Dr., MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Hamburg, Department of Anaesthesiology

Central Contacts

Cynthia Olotu, Dr., MD

Role: CONTACT

c.olotu@uke.de

0049 40 7410 52415

Other Identifiers

2024-101313-BO-ff

Identifier Type: -

Identifier Source: org_study_id