We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Focused Cognitive Testing in Inpatients (FCTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02826473
Recruitment Status : Terminated (Insufficient enrollment of eligible patients)
First Posted : July 11, 2016
Last Update Posted : December 12, 2019
Sponsor:
Collaborator:
University of Lucerne
Information provided by (Responsible Party):
Aljoscha Hwang, Luzerner Kantonsspital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Neurocognitive Disorders Other: BRAINCHECK Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Analysis of Clinical- and Cost-effectiveness of Focused Cognitive Testing in Elective Inpatients
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Arm Intervention/treatment
Experimental: Intervention-Group Other: BRAINCHECK
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).

No Intervention: Control-Group



Primary Outcome Measures :
  1. Health related quality of life (HRQoL) [ Time Frame: every month during 18months ]
    Patient and Caregiver, using EuroQol 5D-5L

  2. Health Service Resource Utilization / Costs [ Time Frame: every month during 18months ]
    Patient and Caregiver, using Resource Utilization in Dementia (RUD)


Secondary Outcome Measures :
  1. prevalence of neurocognitive disorder [ Time Frame: baseline/6months ]
    at Hospital admission

  2. prevalence of risk factors associated with developing major neurocognitive disorder within 6 years [ Time Frame: baseline/6months ]
    at Hospital Admission, using Brief Dementia Screening Indicator (BDSI)


Other Outcome Measures:
  1. caregiver burden [ Time Frame: every 3 months ]
    caregiver data, short Zarit Burden Interview (ZBI)

  2. adverse events/adverse outcomes [ Time Frame: between baseline and 6months ]
    falls, delirium, mortality, mortality within 30 days of discharge, re-admission within 18 days, institutionalization following hospitalization, length of stay

  3. comorbidities [ Time Frame: baseline ]
    patient data, using Charlson Comorbidity Index

  4. neuropsychiatric symptoms [ Time Frame: between baseline and 6months ]
    patient data during Hospital stay, using Neuropsychiatric Inventory Questionnaire (NPI-Q)

  5. hospital anxiety and depression [ Time Frame: every 3 months ]
    patient and caregiver data, using Hospital Anxiety and Depression Scale (HADS)

  6. severity of cognitive impairment [ Time Frame: every 6 months ]
    patients of the Intervention-Group will be assessed every months, using the Montreal Cognitive Assessment (MOCA)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826473


Locations
Layout table for location information
Switzerland
Cantonal Hospital of Lucerne
Lucerne, Canton Lucerne, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital
University of Lucerne
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Aljoscha Hwang, Health Research Manager, Luzerner Kantonsspital
ClinicalTrials.gov Identifier: NCT02826473    
Other Study ID Numbers: LUKS-2016-00140
2016-00140 ( Other Identifier: Ethics Committee Northwest and Central Switzerland )
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aljoscha Hwang, Luzerner Kantonsspital:
Dementia
Dementia screening
General Hospital
Inpatients
Additional relevant MeSH terms:
Layout table for MeSH terms
Neurocognitive Disorders
Mental Disorders