N/A N=101 Randomized Health Services Research

The New Executive and Appendix Template (NEAT) Study

Comprehension · Informed Consent

Bottom Line

View on ClinicalTrials.gov: NCT03419832 ↗

Enrolled (actual)

101

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcome: Primary: Comprehension of the NEAT Form — 10.6; 10.2 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: NEAT Form (Other); Standard Form (Other)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: May 2017

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	—	—

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.

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.

View full record on ClinicalTrials.gov →

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.