Focused Cognitive Testing in Inpatients

Neurocognitive Disorders Clinical Trial

— FCTI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02826473
• Other study ID #: LUKS-2016-00140
• Secondary ID: 2016-00140
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: December 2019
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurocognitive Disorders

Intervention

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).

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital of Lucerne	Lucerne	Canton Lucerne

Sponsors (2)

Lead Sponsor	Collaborator
Luzerner Kantonsspital	University of Lucerne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	caregiver burden	caregiver data, short Zarit Burden Interview (ZBI)	every 3 months
Other	adverse events/adverse outcomes	falls, delirium, mortality, mortality within 30 days of discharge, re-admission within 18 days, institutionalization following hospitalization, length of stay	between baseline and 6months
Other	comorbidities	patient data, using Charlson Comorbidity Index	baseline
Other	neuropsychiatric symptoms	patient data during Hospital stay, using Neuropsychiatric Inventory Questionnaire (NPI-Q)	between baseline and 6months
Other	hospital anxiety and depression	patient and caregiver data, using Hospital Anxiety and Depression Scale (HADS)	every 3 months
Other	severity of cognitive impairment	patients of the Intervention-Group will be assessed every months, using the Montreal Cognitive Assessment (MOCA)	every 6 months
Primary	Health related quality of life (HRQoL)	Patient and Caregiver, using EuroQol 5D-5L	every month during 18months
Primary	Health Service Resource Utilization / Costs	Patient and Caregiver, using Resource Utilization in Dementia (RUD)	every month during 18months
Secondary	prevalence of neurocognitive disorder	at Hospital admission	baseline/6months
Secondary	prevalence of risk factors associated with developing major neurocognitive disorder within 6 years	at Hospital Admission, using Brief Dementia Screening Indicator (BDSI)	baseline/6months