The Boston Circulatory Arrest Study: Antecedents and Correlates of Well-Being in Adults With Congenital Heart Disease (BCAS-Adult)
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|ClinicalTrials.gov Identifier: NCT03073122|
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : September 3, 2019
|Condition or disease||Intervention/treatment|
|Transposition Great Arteries Executive Dysfunction||Diagnostic Test: Brain MRI, neurocognitive and psychological testing|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||The Boston Circulatory Arrest Study: Antecedents and Correlates of Well-Being in Adults With Congenital Heart Disease|
|Actual Study Start Date :||November 9, 2017|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||November 30, 2020|
Brain MRI, Neurocognitive and psychological testing
Diagnostic Test: Brain MRI, neurocognitive and psychological testing
MRI of the brain and multiple tests of neurocognitive and psychological function including executive function, anxiety and depression
- Quality of Life [ Time Frame: baseline ]Linear analog scale, Quality of Life Survey
- Mental health - Anxiety [ Time Frame: baseline ]Hospital Anxiety and Depression scale and the structured clinical interview for DSM-V
- Mental Health - Depression [ Time Frame: baseline ]Hospital Anxiety and Depression scale and the structured clinical interview for DSM-V
- Mental health - ADHD [ Time Frame: baseline ]structured clinical interview for DSM-V and Connors' Adult ADHD Rating Scales - Screening Version
- Mental health - PTSD [ Time Frame: baseline ]structured clinical interview for DSM-V
- Mental health - Stress [ Time Frame: baseline ]1. The Stress & Self-Efficacy (Perceived Stress; Self-Efficacy) subdomain of the NIH Toolbox Emotion Domain
- Neurocognitive - Executive function [ Time Frame: baseline ]
- The Delis-Kaplan Executive Function System (D-KEFS) includes nine subtests: Trail-Making, Verbal Fluency, Design Fluency, Color-Word Interference, Card Sorting, Twenty Questions, Word Context, Tower, and Proverb.
- The NIH Toolbox Assessment of Neurological and Behavioral Function, executive function battery is a set of computerized assessments that measure: (a) Inhibitory control (Flanker Inhibitory Control and Attention Test); (b) Working Memory (List Sorting Working Memory Test); (c) Cognitive Flexibility (Dimensional Change Card Sort Test).
- The NIH Toolbox Processing Speed assesses the time it takes to process a set amount of information. It yields a main endpoint score.
- The Behavior Rating Inventory of Executive Function for Adults (BRIEF-A) includes 75 items that yield 9 clinical scales grouped into two indexes: Behavioral Regulation and Metacognition.
- Neurocognitive - Risk taking behavior [ Time Frame: baseline ]Iowa Gambling Task (IGT)
- Neurocognitive - social cognition [ Time Frame: baseline ]
- The "Reading the Mind in the Eyes" Task (revised) is a computer-administered task assessing mental state attribution.
- The Advanced Clinical Solutions for WAIS-IV and WMS IV (ACS) is a set of tasks that assess aspects of social cognition, such as affect labeling, affect recognition from faces and prosody, identification of sarcasm, and the ability to verbalize intent of a speaker.
- The Autism Spectrum Quotient is a self-report questionnaire covering five domains of autism spectrum disorder: social skills, communication skills, imagination, attention to detail, and attention switching/tolerance of change
- Neurocognitive - memory [ Time Frame: baseline ]
- The NIH Toolbox Picture Sequence Memory Test evaluates episodic memory.
- The Wechsler Memory Scale IV (WMS-IV) provides a comprehensive evaluation of memory abilities in adults, including auditory, visual, immediate, and delayed memory
- mental health - social relatedness [ Time Frame: baseline ]The NIH Toolbox Emotion Domain - The Social Relationships subdomain measures will be administered.
- Employment status [ Time Frame: baseline ]Categories from the National health interview survey and Hollingshead four factor index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073122
|Contact: Michelle Gurvitz, MD||617-355-6508||Michelle.Gurvitz@cardio.chboston.org|
|Principal Investigator:||Michelle Gurvitz, MD||Boston Children's Hospital|