DeliriumDELisoNCT07114458
Delirium and Cognitive Impairment Development in Hospitalized Older Adults Under Isolation Conditions
An observational study of Delirium and Dementia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Delirium, Dementia, Cognitive Impairment
- How many people
- 404 participants
- Where
- 1 siteGermany
- Study dates
- 5 Aug 2025to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: hospitalized patients of the University Medical Centre Hamburg (all departments)
Who may be able to join
- under isolation precautions for at least 24h
- 70 years and above
Who cannot join
- intensive care treatment
- life expectancy 14 days or less
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Hamburg University Medical Centre Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251
Schrum Silke, Dr, 0049407410 ext. 0, s.schrum@uke.de
About this study
Official title: Delirium Incidence and Cognitive Trajectories in Isolated Older Patients in the Inpatient Setting
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.
Read the 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
- Keywords
- Delirium, neurocognitive disorder, older adult, isolation precautions
- Medical subject headings
- Delirium, Dementia, Cognitive Dysfunction, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposition | Patients under isolation precautions in hospital | |
| Control | Matched control, no isolation precautions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Delirium screened by 3D-Confusion Assessment Method 2 times daily
Measured: day 1-5 under isolation precautions
Secondary outcomes (4)
Cognitive performance
Measures by Montreal Cognitive Assessment (MOCA). Maximum 15, minimum 0 points. Higher points indicate less functional impairment.
Measured: 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
Measured: 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
Measured: 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.
Measured: at enrollment and 6 weeks after discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start5 Aug 2025
- Primary completionApr 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Olotu, Dr., MD, Principal investigator, University Medical Centre Hamburg, Department of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114458
- Sponsor's protocol ID
- 2024-101313-BO-ff
- Acronym
- DELiso
- Status last verified
- Jul 2026
- First submitted
- 16 Mar 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium Incidence and Cognitive Trajectories in Isolated Older Patients in the Inpatient Setting
- ClinicalTrials.gov ID
- NCT07114458
- Acronym / sponsor ID
- DELiso / 2024-101313-BO-ff
- Conditions
- Delirium, Dementia, Cognitive Impairment
- Keywords
- Delirium, neurocognitive disorder, older adult, isolation precautions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposition | – | –Patients under isolation precautions in hospital |
| Control | – | –Matched control, no isolation precautions |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- hospitalized patients of the University Medical Centre Hamburg (all departments)
Key inclusion criteria (2 listed)
- under isolation precautions for at least 24h
- 70 years and above
Key exclusion criteria (2 listed)
- intensive care treatment
- life expectancy 14 days or less
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delirium
Time frame: day 1-5 under isolation precautions
Delirium screened by 3D-Confusion Assessment Method 2 times daily
4 secondary outcomes
Cognitive performance
Time frame: at enrollment and six weeks after discharge from hospital
Functional state
Time frame: at enrollment and six weeks after discharge from hospital
Quality-of-Life (QoL)
Time frame: at enrollment and 6 weeks after discharge from hospital
Quality-of-Life (QoL)
Time frame: at enrollment and 6 weeks after discharge from hospital
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cynthia Olotu, Dr., MD principal investigator
University Medical Centre Hamburg, Department of Anaesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Dementia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Olotu, Dr., MD (0049 40 7410 52415, c.olotu@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: day 1-5 under isolation precautions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.