Web-based Application to Test for Long-term Cognitive Deficits in BioCog Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in cognitive performance
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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:
研究组 & 干预措施
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
Former BioCog patients
Former BioCog patients from the Berlin study center who have undergone baseline cognitive testing and from whom plasma samples are available
结局指标
主要结局
Change in cognitive performance
时间窗: 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.
次要结局
- New diagnoses(Participants will be followed for sequelae at 7-10 years after BioCog study inclusion)
- Actual medication(Participants will be followed for sequelae at 7-10 years after BioCog study inclusion)
- Acceptance(Participants will be followed for sequelae at 7-10 years after BioCog study inclusion)
- Usability(Participants will be followed for sequelae at 7-10 years after BioCog study inclusion)
- 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)
- Charlson Comorbidity index(Participants will be followed for sequelae at 7-10 years after BioCog study inclusion)
- History of Falls(Participants will be followed for sequelae at 7-10 years after BioCog study inclusion)
- Depression(Participants will be followed for sequelae at 7-10 years after BioCog study inclusion)
- Weight history(Participants will be followed for sequelae at 7-10 years after BioCog study inclusion)
- Malnutrition Universal Screening Tool (MUST)-Score(Participants will be followed for sequelae at 7-10 years after BioCog study inclusion)
- Body mass index (BMI)(Participants will be followed for sequelae at 7-10 years after BioCog study inclusion)
- Mortality(Participants will be followed for sequelae at 7-10 years after BioCog study inclusion)
研究者
Claudia Spies
Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)
Charite University, Berlin, Germany