Neurocognitive DisordersFCTINCT02826473
Focused Cognitive Testing in Inpatients
A study testing BRAINCHECK in people with Neurocognitive Disorders, run by Luzerner Kantonsspital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Neurocognitive Disorders
- What is being tested?
- BRAINCHECK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2017to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elective inpatients, living in the canton of lucerne, high risk of developing a major neurocognitive disorder, living at home
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cantonal Hospital of Lucerne
Lucerne, Canton Lucerne, 6000
About this study
Official title: 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.
- Conditions
- Neurocognitive Disorders
- Being tested
- BRAINCHECK
- Keywords
- Dementia, Dementia screening, General Hospital, Inpatients
- Medical subject headings
- Neurocognitive Disorders, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention-Group | Experimental | Not described Receives: Other: BRAINCHECK |
| Control-Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life (HRQoL)
Patient and Caregiver, using EuroQol 5D-5L
Measured: every month during 18months
Health Service Resource Utilization / Costs
Patient and Caregiver, using Resource Utilization in Dementia (RUD)
Measured: every month during 18months
Secondary outcomes (2)
prevalence of neurocognitive disorder
at Hospital admission
Measured: baseline/6months
prevalence of risk factors associated with developing major neurocognitive disorder within 6 years
at Hospital Admission, using Brief Dementia Screening Indicator (BDSI)
Measured: baseline/6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start1 Apr 2017
- Primary completion1 May 2019
- Study completion1 May 2019
Why it stopped: Insufficient enrollment of eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Luzern
- Responsible party
- Principal investigator, Aljoscha Hwang, Luzerner Kantonsspital
- Investigators
- Stefan Boes, Prof.Dr., Principal investigator, University of Lucerne,Department of Health Sciences & Health PolicyThomas Nyffeler, Prof.Dr.med., Study chair, Cantonal Hospital of LucerneAljoscha Benjamin, M.A. (HSG), Study chair, Cantonal Hospital of Lucerne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826473
- Sponsor's protocol ID
- LUKS-2016-00140
- Other IDs
- 2016-00140, 2016
- Acronym
- FCTI
- Status last verified
- Dec 2019
- First submitted
- 5 Jul 2016
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical- and Cost-effectiveness of Focused Cognitive Testing in Elective Inpatients
- ClinicalTrials.gov ID
- NCT02826473
- Acronym / sponsor ID
- FCTI / LUKS-2016-00140
- Conditions
- Neurocognitive Disorders
- Keywords
- Dementia, Dementia screening, General Hospital, Inpatients
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment of eligible patients
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Collaborators
- Universität Luzern
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention-Group | Experimental | Other: BRAINCHECK |
| Control-Group | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Elective inpatients, living in the canton of lucerne, high risk of developing a major neurocognitive disorder, living at home
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRAINCHECKSubjects 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). | Other | Intervention-Group |
Primary outcome
Health related quality of life (HRQoL)
Time frame: every month during 18months
Patient and Caregiver, using EuroQol 5D-5L
Health Service Resource Utilization / Costs
Time frame: every month during 18months
Patient and Caregiver, using Resource Utilization in Dementia (RUD)
2 secondary outcomes
prevalence of neurocognitive disorder
Time frame: baseline/6months
prevalence of risk factors associated with developing major neurocognitive disorder within 6 years
Time frame: baseline/6months
Results and safety
The study was stopped early (reason given: Insufficient enrollment of eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Boes, Prof.Dr. principal investigator
University of Lucerne,Department of Health Sciences & Health Policy
Thomas Nyffeler, Prof.Dr.med. study chair
Cantonal Hospital of Lucerne
Aljoscha Benjamin, M.A. (HSG) study chair
Cantonal Hospital of Lucerne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRAINCHECK in people with Neurocognitive Disorders, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment of eligible patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (HRQoL) (time frame: every month during 18months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.