Web-based Application to Test for Long-term Cognitive Deficits in BioCog Patients

Recruiting

• Conditions: Cognitive Deficits

• Registration Number: NCT06716528
• Lead Sponsor: Charite University, Berlin, Germany

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)

Study Timeline

• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Study First Posted: 2024-12-04
• Status Verified: 2025-01
• Study Start: 2025-01-07
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 434

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in cognitive performance	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion	The primary object of research is the explorative investigation of the change in cognitive test performance as well as cognitive self-care and functionality in the long-term follow-up (7 - 10 years) compared to the baseline survey (from the main BioCog study). It is measured with CANTAB Research Suite, CANTAB web-based testing and paper pencil tests.

Secondary Outcome Measures

Name	Time	Method
Mortality	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion	Mortality is measured by the number of deaths.
Acceptance	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion	Acceptance of the CANTAB web-based testing of Cambridge Cognition is measured with a questionnaire.
Usability	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion	Usability of the CANTAB web-based testing of Cambridge Cognition is measured with a questionnaire.
NUcleic acid Linked Immuno-Sandwich Assay Central Nervous System Disease Multiplex Panel	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion	Analysis of 120 proteins.
New diagnoses	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion	Last doctor's letter/last findings (especially in the case of neurological/psychiatric/geriatric connections - e.g. memory consultation) for recording new diagnoses and recording the last outpatient and/or inpatient treatments.
Actual medication	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion	Current comedication and supplements
Charlson Comorbidity index	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion	Comorbidity
History of Falls	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion	History of falls is measured with the question: Have you had a fall event within the last year?
Depression	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion	Depression is measured with Geriatric Depression Scale.
Weight history	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion	Weight history is measured by weight change in the past 3-6 months.
Malnutrition Universal Screening Tool (MUST)-Score	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion	Add Scores together to calculate overall risk of malnutrition with the Malnutrition screening tool: Score 0 corresponds to low risk; Score 1 corresponds to medium risk; Score 2 or more corresponds to high risk.
Body mass index (BMI)	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion	BMI is a calculated measure of a person's body weight (in kilograms) divided by the square of their height (in meters).

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin; 🇩🇪 Berlin, Germany