NCT06716528

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 434 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Cognitive Deficits

Timeline

• Start date: 2025-01-07
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-12-04
• Last updated: 2025-11-21

Locations

1 site across 1 country: Germany