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NCT Number: NCT07114458

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

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.

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Key information

Conditions

Delirium Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Confusion Dementia Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamburg University Medical Centre Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20251, Germany

Location status: Recruiting

Location contact

Schrum Silke, Dr

CONTACT

[email protected]

0049407410

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Delirium

    Time frame: day 1-5 under isolation precautions

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

Secondary outcomes

  1. Cognitive performance

    Time frame: at enrollment and six weeks after discharge from hospital

    Measures by Montreal Cognitive Assessment (MOCA). Maximum 15, minimum 0 points. Higher points indicate less functional impairment.

  2. Functional state

    Time frame: at enrollment and six weeks after discharge from hospital

    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

  3. Quality-of-Life (QoL)

    Time frame: at enrollment and 6 weeks after discharge from hospital

    QoL assessed by WHO Quality of Life in older adults (WHO-QOL-OLD) questionnaire

  4. Quality-of-Life (QoL)

    Time frame: at enrollment and 6 weeks after discharge from hospital

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Olotu, Dr., MD

CONTACT

[email protected]

0049 40 7410 52415

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: DELiso

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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