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

NCT ID: NCT06716528

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

434 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-07

Study Completion Date

2026-04-30

Brief Summary

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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

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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)

Conditions

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Cognitive Deficits

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Former BioCog patients

Former BioCog patients from the Berlin study center who have undergone baseline cognitive testing and from whom plasma samples are available

No interventions assigned to this group

Former BioCog subjects in the non-surgical comparison cohort

Former BioCog subjects in the non-surgical comparison cohort from the Berlin study center who have undergone baseline cognitive testing

No interventions assigned to this group

Eligibility Criteria

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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


-None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role collaborator

Universitätsklinikum Essen

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia Spies

Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Spies, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Charitè - University Berlin

Locations

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

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Claudia Spies, MD, Prof.

Role: CONTACT

+49 30 450 551102

Facility Contacts

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Claudia Spies, MD, Prof.

Role: primary

+49 30 450 55 12 98

Other Identifiers

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BioCog-Web

Identifier Type: -

Identifier Source: org_study_id

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