Clinical trial NCT06716528: Web-based Application to Test for Long-term Cognitive Deficits in BioCog Patients
Official title: Web-based Application to Test for Long-term Cognitive Deficits in BioCog Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Deficits
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: University Hospital, Bonn
name: University Hospital Schleswig-Holstein
name: Universitätsklinikum Essen
First posted: 2024-12-04
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients and subjects from the Berlin BioCog cohort.

Brief summary: In the present study, a long-term cognitive follow-up of participants of the BioCog cohort (data collection period 2014 - 2019, Ethical vote No: EA2/092/14) from the Berlin study center is to be will be performed in order to record long-term cognitive sequelae (7 to 10 years after study inclusion). In addition to a medical telephone/video visit, the follow-up includes the collection of cognitive tests via web applications and questionnaires of acceptance and usability in the home environment. The study data are analysed in cooperation with the University of Bonn, University Medical Center Schleswig-Holstein and the University of Essen.

Detailed description: The primary research objective is the exploratory investigation of changes in cognitive test performance as well as cognitive self-care and functionality in former BioCog patients and BioCog subjects in the non-surgical comparison cohort in the long-term follow-up (7 - 10 years) compared to the baseline survey (from the BioCog main study).The primary question is operationalized in several ways:

* according to the International Statistical Classification of Diseases and Related Health Problems(ICD-10) classification system
* according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) classification system
* computer-based, online and independently conducted cognitive testing using Cantab Web based testing from Cambridge Cognition
* Cognitive self-care using Geriatric depression Scale item 10
* Cognitive self-care with Multifactorial Memory Questionnaire
* Cognitive other-care with The Informant Questionnaire on Cognitive Decline in the Elderly questionnaire
* Functionality with Activities of Daily Living (ADLs) \& Instrumental Activities of Daily Living (IADLs) questionnaire
* Additionally: Quality of life with 5-level EQ-5D version (EQ-5D-5L)

Evaluation by Mild Cognitive Impairment Algorithm of the University Clinic Bonn (research group Prof. Wagner).

Evaluation by mild/major Neurocognitive Disorder (NCD) algorithm of Charité - University Medicine Berlin (research group Prof. Spies)

Eligibility criteria: Patients

Inclusion Criteria:

* Patients of Berliner BioCog cohort with cognitive Testing (CANTAB Research Suite) at Baseline and with plasma samples for baseline that can be contacted.
* Written informed consent for participation in the BioCog-Web study.
* Data and reserve samples from patients in the Berlin BioCog cohort who can no longer be contacted.

Exclusion Criteria:

* None

Subjects

Inclusion Criterion:

-BioCog subjects of the non-operated comparison cohort from Berlin with cognitive testing (CANTAB Research Suite) at baseline who are contactable

Exclusion criteria:

-None

Primary outcomes:
measure: Change in cognitive performance
timeFrame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Secondary outcomes:
measure: Acceptance
timeFrame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
measure: Usability
timeFrame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
measure: NUcleic acid Linked Immuno-Sandwich Assay Central Nervous System Disease Multiplex Panel
timeFrame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
measure: New diagnoses
timeFrame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
measure: Actual medication
timeFrame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
measure: Charlson Comorbidity index
timeFrame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
measure: History of Falls
timeFrame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
measure: Depression
timeFrame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
measure: Weight history
timeFrame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
measure: Malnutrition Universal Screening Tool (MUST)-Score
timeFrame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
measure: Body mass index (BMI)
timeFrame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
measure: Mortality
timeFrame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin
Study officials:
affiliation: Charitè - University Berlin
name: Claudia Spies, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: