Delirium and Cognitive Impairment Development in Hospitalized Older Adults Under Isolation Conditions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70+
SponsorUniversitätsklinikum Hamburg-Eppendorf
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
hospitalized patients
under isolation precautions for at least 24h
70 years and above
Disqualifiers
no informed consent
intensive care treatment
life expectancy 14 days or less
Trial population
hospitalized patients of the University Medical Centre Hamburg (all departments)
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
404 Participants
are grouped into 2 trial groupsGroup A: Exposition
Group B: Control
Trial outcomes
Primary outcomes
1
Delirium
Delirium screened by 3D-Confusion Assessment Method 2 times daily
Time frame
day 1-5 under isolation precautionsSecondary outcomes
1
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 hospital2
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 hospital3
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 hospital4
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 hospitalSponsors and contacts
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Source ClinicalTrials.gov