Delirium and Cognitive Impairment Development in Hospitalized Older Adults Under Isolation Conditions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Delirium, Dementia, Cognitive Impairment. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Delirium Incidence and Cognitive Trajectories in Isolated Older Patients in the Inpatient Setting
Overview
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.
Primary outcome measures
- Delirium [Time frame: day 1-5 under isolation precautions]
Secondary outcome measures (4)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Germany · 1 center
- Hamburg University Medical Centre Eppendorf — Hamburg
Identifiers
NCT: NCT07114458 · 2024-101313-BO-ff