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NCT03419832 · ClinicalTrials.gov registry record · NA
The New Executive and Appendix Template (NEAT) Study
A NA study of Informed Consent and Comprehension, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 101
- Enrollment target
- 1
- Study location
NCT03419832: Completed NA study of Informed Consent and Comprehension, sponsored by Wake Forest University Health Sciences.
NCT03419832 is a NA study of Informed Consent and Comprehension that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 101 participants, below the 906-participant average among 9 other Informed Consent trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03419832, a NA study of Informed Consent and Comprehension, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 101 participants
- Enrollment target
- 1
- Study location
Study Summary
There is evidence that the current design and content provided by most biomedical research informed consent documents do not consistently meet the expectations researchers place on them to effectively inform research participants of information thought to be most important in facilitating their ability to make informed decisions about participation. The need for revisions to the informed consent document design is supported by empirical research.This pilot study will examine the effectiveness of the New Executive and Appendix Template (NEAT) form when used in the consent process for individuals participating in the Atherosclerosis Risk in Communities (ARIC) Neurocognitive Study.
Primary Outcome
Following the consent process, participants will be administered the Comprehension tool to measure their comprehension. The summary scores will be used to address the primary aim of whether or not the NEAT consent form improves participant comprehension. There are 7 questions, each question is rated 0-2 with a total scale of 0-14. Higher values denotes better outcomes.
Conditions Studied
Interventions
- OTHER NEAT Form
- OTHER Standard Form
Study Locations (1)
North Carolina
- Wake Forest Baptist Medical Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2017-04-04 |
| Est. Completion | 2017-05-23 |
| Phase | NA |
What the finished NCT03419832 record still lists
NCT03419832 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 906-participant average among 9 other Informed Consent trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Informed Consent appearing as the primary indexed condition, and to 2 interventions - of which NEAT Form is the first listed.
NCT03419832 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03419832 about?
NCT03419832 is a clinical study titled "The New Executive and Appendix Template (NEAT) Study". There is evidence that the current design and content provided by most biomedical research informed consent documents do not consistently meet the expectations researchers place on them to effectively inform research participants of information thought to be most important in facilitating their abil...
What is the current status of trial NCT03419832?
This trial is currently completed. It is a NA study. The enrollment target is 101 participants. The study started on 2017-04-04. Estimated completion is 2017-05-23.
What conditions does trial NCT03419832 study?
This clinical trial studies the following conditions: Informed Consent, Comprehension.
What interventions are being tested in trial NCT03419832?
The interventions under investigation include: NEAT Form (OTHER), Standard Form (OTHER).
Who is sponsoring clinical trial NCT03419832?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03419832 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03419832's enrollment target sits among peer trials
101 8th of 9 higher than 2 of 9 other Informed Consent trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Informed Consent trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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