NCT02826473

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

2.1 years

First QC Date

July 5, 2016

Last Update Submit

December 10, 2019

Conditions

Neurocognitive Disorders

Keywords

DementiaDementia screeningGeneral HospitalInpatients

Outcome Measures

Primary Outcomes (2)

  • Health related quality of life (HRQoL)

    Patient and Caregiver, using EuroQol 5D-5L

    every month during 18months

  • Health Service Resource Utilization / Costs

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

    every month during 18months

Secondary Outcomes (2)

  • prevalence of neurocognitive disorder

    baseline/6months

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

    baseline/6months

Other Outcomes (6)

  • caregiver burden

    every 3 months

  • adverse events/adverse outcomes

    between baseline and 6months

  • comorbidities

    baseline

  • +3 more other outcomes

Study Arms (2)

Intervention-Group

EXPERIMENTAL
Other: BRAINCHECK

Control-Group

NO INTERVENTION

Interventions

BRAINCHECKOTHER

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).

Intervention-Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elective inpatients, living in the canton of lucerne, high risk of developing a major neurocognitive disorder, living at home

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cantonal Hospital of Lucerne

Lucerne, Canton Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Neurocognitive DisordersDementia

Condition Hierarchy (Ancestors)

Mental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Stefan Boes, Prof.Dr.

    University of Lucerne,Department of Health Sciences & Health Policy

    PRINCIPAL INVESTIGATOR

  • Thomas Nyffeler, Prof.Dr.med.

    Cantonal Hospital of Lucerne

    STUDY CHAIR

  • Aljoscha Benjamin, M.A. (HSG)

    Cantonal Hospital of Lucerne

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health Research Manager

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 11, 2016

Study Start

April 1, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

December 12, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)