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About
Objectives:
It is hypothesized that when using a tablet-based cognitive testing software - Cambridge Cognition (specifically to assess executive function, learning and working memory: Rapid Visual Information Processing test, Spatial Working Memory/Spatial Span Task tests, One touch Stockings of Cambridge test, Cambridge Gambling Task, Multitasking Test/Intra-Extra Dimensional Set shift tests) - a significant difference will be noted between how the patients perform while in atrial fibrillation compared to the patients' performance while in normal sinus rhythm.
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Inclusion Criteria
Method of Recruitment
Patients may also be phone consented and complete the testing at home via web-based testing.
• Patients of CSC with a known history of AF with be contacted with information on the study. If the patient is interested and have had >3 documented episodes of AF over the preceding 12 months they will be invited to pre-enroll in the study with the intention of having the subject already enrolled in the study before their next episode of AF.
Procedure:
The study involves an observational study design. Before the study begins:
• All nursing and study personnel participating in the study will undergo routine in-service notification/training about the study.
After the study is open:
Number of Subjects Previous similar studies suggest various findings for their effect size11. However, all the findings have been consistently supporting association between atrial fibrillation and cognitive impairment. Based upon a power of 80% and alpha of 0.05, most of the studies suggesting a need of over 250 subjects (98-472), therefore up to 600 subjects will be recruited in this study with a goal of obtaining data on at least 250 participants.
PROCEDURES TO MINIMIZE RISKS To minimize risks associated with breach of confidentiality all data will be entered into Centura work stations where clinicians enter patient data into the Electronic Medical Record (EMR), which is the patient's clinical record, that includes firewall and password protection. Data pertinent to this study will be transferred to a Centura Health password protected computer in a non-identifiable manner. All identifiable data will be kept in a key protected room only accessible by the research staff.
To minimize risks associated with psychological discomfort as a result of taking the Cambridge Cognition test or its results, breaks will be given where appropriate and the patient will be reminded frequently that they may stop the test at any time should they feel uncomfortable.
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Exclusion criteria
600 participants in 1 patient group
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Central trial contact
Diana Adkins, BSN; David R Brunk, PA-C, MMS
Data sourced from clinicaltrials.gov
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