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Focused Cognitive Testing in Inpatients (FCTI)

Primary Purpose

Neurocognitive Disorders

Status

Terminated

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

BRAINCHECK

About this trial

This is an interventional supportive care trial for Neurocognitive Disorders focused on measuring Dementia, Dementia screening, General Hospital, Inpatients

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cantonal Hospital of Lucerne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention-Group

Control-Group

Arm Description

Outcomes

Primary Outcome Measures

Health related quality of life (HRQoL)

Patient and Caregiver, using EuroQol 5D-5L

Health Service Resource Utilization / Costs

Patient and Caregiver, using Resource Utilization in Dementia (RUD)

Secondary Outcome Measures

prevalence of neurocognitive disorder

at Hospital admission

prevalence of risk factors associated with developing major neurocognitive disorder within 6 years

at Hospital Admission, using Brief Dementia Screening Indicator (BDSI)

Full Information

NCT ID

NCT02826473

First Posted

July 5, 2016

Last Updated

December 10, 2019

Sponsor

Luzerner Kantonsspital

Collaborators

Universität Luzern

1. Study Identification

Unique Protocol Identification Number

NCT02826473

Brief Title

Focused Cognitive Testing in Inpatients

Acronym

FCTI

Official Title

Analysis of Clinical- and Cost-effectiveness of Focused Cognitive Testing in Elective Inpatients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Terminated

Why Stopped

Insufficient enrollment of eligible patients

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

May 1, 2019 (Actual)

Study Completion Date

May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Luzerner Kantonsspital

Collaborators

Universität Luzern

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurocognitive Disorders

Keywords

Dementia, Dementia screening, General Hospital, Inpatients

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention-Group

Arm Type

Experimental

Arm Title

Control-Group

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

BRAINCHECK

Intervention Description

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).

Primary Outcome Measure Information:

Title

Health related quality of life (HRQoL)

Description

Patient and Caregiver, using EuroQol 5D-5L

Time Frame

every month during 18months

Title

Health Service Resource Utilization / Costs

Description

Patient and Caregiver, using Resource Utilization in Dementia (RUD)

Time Frame

every month during 18months

Secondary Outcome Measure Information:

Title

prevalence of neurocognitive disorder

Description

at Hospital admission

Time Frame

baseline/6months

Title

prevalence of risk factors associated with developing major neurocognitive disorder within 6 years

Description

at Hospital Admission, using Brief Dementia Screening Indicator (BDSI)

Time Frame

baseline/6months

Other Pre-specified Outcome Measures:

Title

caregiver burden

Description

caregiver data, short Zarit Burden Interview (ZBI)

Time Frame

every 3 months

Title

adverse events/adverse outcomes

Description

falls, delirium, mortality, mortality within 30 days of discharge, re-admission within 18 days, institutionalization following hospitalization, length of stay

Time Frame

between baseline and 6months

Title

comorbidities

Description

patient data, using Charlson Comorbidity Index

Time Frame

baseline

Title

neuropsychiatric symptoms

Description

patient data during Hospital stay, using Neuropsychiatric Inventory Questionnaire (NPI-Q)

Time Frame

between baseline and 6months

Title

hospital anxiety and depression

Description

patient and caregiver data, using Hospital Anxiety and Depression Scale (HADS)

Time Frame

every 3 months

Title

severity of cognitive impairment

Description

patients of the Intervention-Group will be assessed every months, using the Montreal Cognitive Assessment (MOCA)

Time Frame

every 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefan Boes, Prof.Dr.

Organizational Affiliation

University of Lucerne,Department of Health Sciences & Health Policy

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thomas Nyffeler, Prof.Dr.med.

Organizational Affiliation

Cantonal Hospital of Lucerne

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Aljoscha Benjamin, M.A. (HSG)

Organizational Affiliation

Cantonal Hospital of Lucerne

Official's Role

Study Chair

Facility Information:

Facility Name

Cantonal Hospital of Lucerne

City

Lucerne

State/Province

Canton Lucerne

ZIP/Postal Code

6000

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Focused Cognitive Testing in Inpatients

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