- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02826473
Focused Cognitive Testing in Inpatients (FCTI)
Analysis of Clinical- and Cost-effectiveness of Focused Cognitive Testing in Elective Inpatients
Neurocognitive Disorder (NCD) affects over 116'000 people in Switzerland and is frequently unrecognized and underdiagnosed. Because missed and delayed diagnosis are associated with an increased burden of disease health Service Research has prompted a discussion about diagnostic guidelines and screening programs. Some argue that screening for NCD in primary care is the optimal strategy to increase recognition rates; others consider test protocols implemented into hospital admission assessments as more justified. There is no distinct recommendation due to a lack of empirical data on the benefits and harms of cognitive testing yet. This trial strives to fill this gap and provide information about the benefits, harms and the economic case of routine cognitive testing for neurocognitive disorder in high risk elective inpatients, in Switzerland.
The investigators hypothesize that, cognitive tested patients, compared with patients not cognitive tested, will have higher health-related quality of life at 12months; and lower medical health care costs at 18months.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Canton Lucerne
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Lucerne, Canton Lucerne, Switzerland, 6000
- Cantonal Hospital of Lucerne
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Elective inpatients, living in the canton of lucerne, high risk of developing a major neurocognitive disorder, living at home
Exclusion Criteria:
- Known mental disorder according to ICD-10, chapter V, excluding F32 & F33, patients with terminal illness, patients of intensive care unit or oncology patients, no adequate vision or hearing, no ability to speak, write or to understand German, no Informant, antidementia medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention-Group
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Subjects of the Intervention-Group will undergo a brief cognitive assessment, using the BRAINCHECK, during hospital admission assessments.
Subjects with positive results will then be referred to a Memory Clinic undergoing subsequent interdisciplinary comprehensive diagnostic examinations.
Patients with established diagnosis will be invited to counselling services of the Alzheimer Association (providing social counselling).
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No Intervention: Control-Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related quality of life (HRQoL)
Time Frame: every month during 18months
|
Patient and Caregiver, using EuroQol 5D-5L
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every month during 18months
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Health Service Resource Utilization / Costs
Time Frame: every month during 18months
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Patient and Caregiver, using Resource Utilization in Dementia (RUD)
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every month during 18months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence of neurocognitive disorder
Time Frame: baseline/6months
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at Hospital admission
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baseline/6months
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prevalence of risk factors associated with developing major neurocognitive disorder within 6 years
Time Frame: baseline/6months
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at Hospital Admission, using Brief Dementia Screening Indicator (BDSI)
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baseline/6months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
caregiver burden
Time Frame: every 3 months
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caregiver data, short Zarit Burden Interview (ZBI)
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every 3 months
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adverse events/adverse outcomes
Time Frame: between baseline and 6months
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falls, delirium, mortality, mortality within 30 days of discharge, re-admission within 18 days, institutionalization following hospitalization, length of stay
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between baseline and 6months
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comorbidities
Time Frame: baseline
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patient data, using Charlson Comorbidity Index
|
baseline
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neuropsychiatric symptoms
Time Frame: between baseline and 6months
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patient data during Hospital stay, using Neuropsychiatric Inventory Questionnaire (NPI-Q)
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between baseline and 6months
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hospital anxiety and depression
Time Frame: every 3 months
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patient and caregiver data, using Hospital Anxiety and Depression Scale (HADS)
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every 3 months
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severity of cognitive impairment
Time Frame: every 6 months
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patients of the Intervention-Group will be assessed every months, using the Montreal Cognitive Assessment (MOCA)
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every 6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stefan Boes, Prof.Dr., University of Lucerne,Department of Health Sciences & Health Policy
- Study Chair: Thomas Nyffeler, Prof.Dr.med., Cantonal Hospital of Lucerne
- Study Chair: Aljoscha Benjamin, M.A. (HSG), Cantonal Hospital of Lucerne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LUKS-2016-00140
- 2016-00140 (Other Identifier: Ethics Committee Northwest and Central Switzerland)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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