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 : January 31, 2018
|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 :||October 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
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|
|United States, Massachusetts|
|Boston Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Michelle Gurvitz, MD 617-355-6508 email@example.com|
|Contact: Donna Duva 617-355-5422 firstname.lastname@example.org|
|Principal Investigator:||Michelle Gurvitz, MD||Boston Children’s Hospital|