An observational study in Delirium, Dementia and Cognitive Impairment, sponsored by Universitätsklinikum Hamburg-Eppendorf. Recruiting at 1 site in Germany. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
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.
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.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's planned enrollment of 404 is above the median of 194 across 342 observational studies indexed under Delirium.
Browse Delirium studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
hospitalized patients of the University Medical Centre Hamburg (all departments)
Inclusion Criteria: - hospitalized patients
Exclusion Criteria: - no
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients under isolation precautions in hospital
Matched control, no isolation precautions
Delirium
Delirium screened by 3D-Confusion Assessment Method 2 times daily
Time frame: day 1-5 under isolation precautions
Cognitive performance
Measures by Montreal Cognitive Assessment (MOCA). Maximum 15, minimum 0 points. Higher points indicate less functional impairment.
Time frame: at enrollment and six weeks after discharge from hospital
Functional state
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
Time frame: at enrollment and six weeks after discharge from hospital
Quality-of-Life (QoL)
QoL assessed by WHO Quality of Life in older adults (WHO-QOL-OLD) questionnaire
Time frame: at enrollment and 6 weeks after discharge from hospital
Quality-of-Life (QoL)
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.
Time frame: at enrollment and 6 weeks after discharge from hospital
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Apr 2027, 20 months after the start.
Of 176 non-industry observational studies under Delirium, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's planned 20 months is close to that.
Counting every sponsor, half of 178 studies reached it within 20 months; a quarter within 11 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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