Decisional Capacity and Informed Consent in Fragile X Syndrome
2 other identifiers
interventional
152
1 country
1
Brief Summary
The Decisional Capacity and Informed Consent in Fragile X Syndrome (FXS) project is for the Eunice Kennedy Shriver National Institute of Child Health \& Human Development, 1R01HD071987-01A1, and will provide the first comprehensive description of decisional capacity of individuals with FXS; identify individual, family, and experiential factors associated with variability in decisional capacity; determine the validity of caregiver and expert ratings; and develop evidence-based guidelines for categorizing decisional capacity of individuals with FXS. The researchers will develop a methodologically rigorous and conceptually grounded decision aid using digital technology to enhance participation of individuals with FXS in the consent process.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2015
CompletedFirst Posted
Study publicly available on registry
June 9, 2015
CompletedStudy Start
First participant enrolled
March 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2017
CompletedResults Posted
Study results publicly available
December 6, 2018
CompletedMarch 7, 2019
February 1, 2019
1 year
May 22, 2015
November 12, 2018
February 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decisional Capacity - Understanding Score
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.
Day 1, immediately following presentation of the material in the intervention or comparison condition
Study Arms (2)
Comparison Condition
OTHERPaper and pencil informed consent
Intervention condition
EXPERIMENTALDigital informed consent tool
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Places in the first 3 categories of the MacCAT flip chart
- Can provide informed consent using a standard practice
You may not qualify if:
- Not in the first 3 categories of the MacCAT flipchart
- Not able to provide informed consent without significant modifications to consent procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
RTI International
Research Triangle Park, North Carolina, 27709, United States
Related Publications (2)
Furberg RD, Raspa M, Wheeler AC, McCormack LA, Bailey DB. A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Nov 19;7(11):e10360. doi: 10.2196/10360.
PMID: 30455171DERIVEDFurberg RD, Ortiz AM, Moultrie RR, Raspa M, Wheeler AC, McCormack LA, Bailey DB Jr. A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development. JMIR Res Protoc. 2018 Jun 6;7(6):e10525. doi: 10.2196/10525.
PMID: 29875084DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Don Bailey
- Organization
- RTI International
Study Officials
- STUDY DIRECTOR
Robert Furberg, PhD
RTI International
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2015
First Posted
June 9, 2015
Study Start
March 14, 2016
Primary Completion
March 21, 2017
Study Completion
March 21, 2017
Last Updated
March 7, 2019
Results First Posted
December 6, 2018
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share