N/A
Completed N=101
The New Executive and Appendix Template (NEAT) Study
Comprehension · Informed Consent
Source: ClinicalTrials.gov NCT03419832 ↗
Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Comprehension of the NEAT Form — 10.6; 10.2 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comprehension of the NEAT Form |
10.6; 10.2 | — |
| SECONDARY Qualitative Analysis of the Readability and Understandability of the Consent Form by Participants |
18; 9; 12; 9; 19; 24 | — |
| SECONDARY Qualitative Analysis of the Format and Design of the Consent Form by Participants |
14; 13; 22; 14; 16; 18 | — |
| SECONDARY Qualitative Analysis of the Time of Discussion of the Consent Form by Participants |
9; 9; 16; 9; 18; 13 | — |
| SECONDARY Qualitative Analysis of the Format and Design of the Consent Form by Study Team |
— | — |
Eligibility Criteria
Inclusion Criteria
- Individuals who are eligible for the ARIC study, with which this pilot study is cooperating.
Exclusion Criteria
- Any individuals not eligible for the ARIC study.
Data sourced from ClinicalTrials.gov (NCT03419832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.