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

Delirium Incidence and Cognitive Trajectories in Isolated Older Patients in the Inpatient Setting

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07114458
Acronym
DELiso
Enrollment
404
Registered
2025-08-11
Start date
2025-08-05
Completion date
2027-11-01
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Delirium, Dementia

Keywords

Delirium, neurocognitive disorder, older adult, isolation precautions

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.

Interventions

None listed

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Deliriumday 1-5 under isolation precautionsDelirium screened by 3D-Confusion Assessment Method 2 times daily

Secondary

MeasureTime frameDescription
Cognitive performanceat enrollment and six weeks after discharge from hospitalMeasures by Montreal Cognitive Assessment (MOCA). Maximum 15, minimum 0 points. Higher points indicate less functional impairment.
Functional stateat enrollment and six weeks after discharge from hospitalDaily 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 hospitalQoL assessed by WHO Quality of Life in older adults (WHO-QOL-OLD) questionnaire

Countries

Germany

Contacts

CONTACTCynthia Olotu, Dr., MD
c.olotu@uke.de0049 40 7410 52415
PRINCIPAL_INVESTIGATORCynthia Olotu, Dr., MD

University Medical Centre Hamburg, Department of Anaesthesiology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026