Clinical trial NCT03419832: The New Executive and Appendix Template (NEAT) Study
Official title: The NEAT Study: An Examination of a Novel Consent Form Design in a Real-world Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comprehension
Informed Consent
Keywords: ARIC
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2018-02-05
Enrollment: 101
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: The importance of informed consent is to ensure that participants in clinical research are provided the opportunity to make autonomous choices is a paramount ethical premise in human research. The effectiveness of consent document design and consent process to accurately and fully convey the elements of informed consent is critical and deserves further study. Development of an improved informed consent document design for clinical studies would be a valuable contribution to human research. Chunking sentences or phrases in text into related groupings resulted in a positive significant improvement in reading comprehension among students with poor reading skills. Because the information contained in consent documents can be complex, detailed, and novel for potential research participants, the use of a modified form of chunking may be an effective and a low cost way of improving comprehension of the elements of consent. Specifically, the primary objective of the study is to determine if participants who receive the NEAT form report greater comprehension at the end of the consent process, than participants who receive a standard form.

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.

Primary outcomes:
measure: Comprehension of the NEAT Form
timeFrame: at visit one, up to 24 hours
Secondary outcomes:
measure: Qualitative Analysis of the Readability and Understandability of the Consent Form by Participants
timeFrame: at visit one, up to 24 hours
measure: Qualitative Analysis of the Format and Design of the Consent Form by Participants
timeFrame: at visit one, up to 24 hours
measure: Qualitative Analysis of the Time of Discussion of the Consent Form by Participants
timeFrame: at visit one, up to 24 hours
measure: Qualitative Analysis of the Format and Design of the Consent Form by Study Team
timeFrame: at visit one, up to 24 hours
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joseph Andrews, PhD
role: PRINCIPAL_INVESTIGATOR
References: