Decisional Capacity and Informed Consent in Fragile X Syndrome
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|ClinicalTrials.gov Identifier: NCT02465931|
Recruitment Status : Completed
First Posted : June 9, 2015
Results First Posted : December 6, 2018
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fragile X Syndrome (FXS)||Other: Paper and Pencil Informed Consent Other: Digital Informed Consent Tool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Decisional Capacity and Informed Consent in Fragile X Syndrome|
|Actual Study Start Date :||March 14, 2016|
|Actual Primary Completion Date :||March 21, 2017|
|Actual Study Completion Date :||March 21, 2017|
Paper and pencil informed consent
Other: Paper and Pencil Informed Consent
Paper-based informed consent form will be sent to participant and family before data collection visit. They will be able to review as many times as they wish before visit. During visits, simplified overview of informed consent form will be provided in person just once. For MacArthur Competence Assessment Tool (MacCAT) Questions, All questions will be asked after the disclosure information has been presented. Questions will have the same wording as experimental condition. Procedures will mimic MacCAT/flipchart (incorrect or partial credit will be given opportunity to answer question again after disclosure information is repeated). There will be multiple choice options rather than open-ended. Finally, data collection will be done through paper and pencil.
Experimental: Intervention condition
Digital informed consent tool
Other: Digital Informed Consent Tool
Paper informed consent form will be sent to participant and family before data collection visit. They will be able to review as many times as they wish before visit. During visits, the participant can go through the tablet-based tool up to 3 times. All questions will be embedded within the vignettes/presentation of disclosure information. Question will use simplified wording, similar to flipchart. Procedures will mimic MacArthur Competence Assessment Tool (MacCAT) /flipchart (incorrect or partial credit will be given opportunity to answer question again after disclosure information is repeated). Multiple choice options will be utilized rather than open-ended. Finally, response data stored within tool and exported to dataset for analysis.
- Decisional Capacity - Understanding Score [ Time Frame: Day 1, immediately following presentation of the material in the intervention or comparison condition ]MacArthur Decisional Capacity - understanding score, range 0 (no understanding) to 26 (perfect understanding) A summary score was calculated, ranging from 0-26. Scores were then translated into a percentage based on the number of questions answered. A score of 100% indicates that the participant answered each understanding question correctly on the first attempt.
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): NCT02465931
|United States, North Carolina|
|Research Triangle Park, North Carolina, United States, 27709|
|Study Director:||Robert Furberg, PhD||RTI International|