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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 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.

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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.

Interventions

  • OTHER NEAT Form
  • OTHER Standard Form

Study Locations (1)

North Carolina

  • Wake Forest Baptist Medical Center - Winston-Salem

Trial Details

FieldValue
Enrollment Target 101 participants
Start Date 2017-04-04
Est. Completion 2017-05-23
Phase NA

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT03419832

The ClinicalTrials.gov registry entry for NCT03419832 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 906-participant average among 9 other Informed Consent trials with a reported enrollment target (89% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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