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

NCT07114458 | Not Yet Recruiting

• 1 other identifier: 2024-101313-BO-ff
• Study Type: observational
• Target: 404
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Delirium; Dementia; Cognitive Impairment

Keywords

Delirium; neurocognitive disorder; older adult; isolation precautions

Outcome Measures

Primary Outcomes (1)

• Delirium

  Delirium screened by 3D-Confusion Assessment Method 2 times daily

  day 1-5 under isolation precautions

Secondary Outcomes (4)

• Cognitive performance

  at enrollment and six weeks after discharge from hospital

• Functional state

  at enrollment and six weeks after discharge from hospital

• Quality-of-Life (QoL)

  at enrollment and 6 weeks after discharge from hospital

• Quality-of-Life (QoL)

  at enrollment and 6 weeks after discharge from hospital

Study Arms (2)

Exposition

Patients under isolation precautions in hospital

Control

Matched control, no isolation precautions

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospitalized patients of the University Medical Centre Hamburg (all departments)

You may qualify if:

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

You may not qualify if:

• intensive care treatment
• life expectancy 14 days or less

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

MeSH Terms

Conditions

Delirium; Dementia; Cognitive Dysfunction; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Cognition Disorders

Study Officials

• Cynthia Olotu, Dr., MD

  University Medical Centre Hamburg, Department of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Olotu, Dr., MD

CONTACT

0049 40 7410 52415; c.olotu@uke.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: August 11, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share