Delirium and Cognitive Impairment Development in Hospital... | NCT07114458

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

NCT07114458

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Not yet recruiting

Last Update Posted

Aug 11, 2025Actual

Enrollment

404Estimated

Phase

Not provided

Conditions

Delirium
Dementia
Cognitive Impairment

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 5, 2025Estimated

Primary Completion Date

Apr 2027Estimated

Completion Date

Nov 2027Estimated

First Submitted Date

Mar 16, 2025

First Submission Date that Met QC Criteria

Aug 3, 2025

First Posted Date

Aug 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2025

Last Update Posted Date

Aug 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

404Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exposition		Patients under isolation precautions in hospital
Control		Matched control, no isolation precautions

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Cognitive performance	Measures by Montreal Cognitive Assessment (MOCA). Maximum 15, minimum 0 points. Higher points indicate less functional impairment.	at enrollment and six weeks after discharge from hospital
Functional state

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cynthia Olotu, Dr., MD	Contact	0049 40 7410 52415		c.olotu@uke.de

Overall Officials

Name	Affiliation	Role
Cynthia Olotu, Dr., MD	University Medical Centre Hamburg, Department of Anaesthesiology	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium
D003704	Dementia
D060825	Cognitive Dysfunction
D019965	Neurocognitive Disorders

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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