Focused Cognitive Testing in Inpatients (FCTI)

December 10, 2019 updated by: Aljoscha Hwang, Luzerner Kantonsspital

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

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Canton Lucerne
      • Lucerne, Canton Lucerne, Switzerland, 6000
        • Cantonal Hospital of Lucerne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Intervention-Group
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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of neurocognitive disorder
Time Frame: baseline/6months
at Hospital admission
baseline/6months
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)
baseline/6months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
caregiver burden
Time Frame: every 3 months
caregiver data, short Zarit Burden Interview (ZBI)
every 3 months
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
between baseline and 6months
comorbidities
Time Frame: baseline
patient data, using Charlson Comorbidity Index
baseline
neuropsychiatric symptoms
Time Frame: between baseline and 6months
patient data during Hospital stay, using Neuropsychiatric Inventory Questionnaire (NPI-Q)
between baseline and 6months
hospital anxiety and depression
Time Frame: every 3 months
patient and caregiver data, using Hospital Anxiety and Depression Scale (HADS)
every 3 months
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)
every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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