The New Executive and Appendix Template (NEAT) Study

NCT03419832 | Completed Results

• 2 other identifiers: IRB000319045UL1TR001420-03
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Comprehension; Informed Consent

Keywords

ARIC

Outcome Measures

Primary Outcomes (1)

• Comprehension of the NEAT Form

  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.

  at visit one, up to 24 hours

Secondary Outcomes (4)

• Qualitative Analysis of the Readability and Understandability of the Consent Form by Participants

  at visit one, up to 24 hours

• Qualitative Analysis of the Format and Design of the Consent Form by Participants

  at visit one, up to 24 hours

• Qualitative Analysis of the Time of Discussion of the Consent Form by Participants

  at visit one, up to 24 hours

• Qualitative Analysis of the Format and Design of the Consent Form by Study Team

  at visit one, up to 24 hours

Study Arms (2)

NEAT Form

EXPERIMENTAL

Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).

Other: NEAT Form

Standard Form

ACTIVE COMPARATOR

Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).

Other: Standard Form

Interventions

NEAT Form OTHER

The NEAT form consists of a clear and concise overview document containing information satisfying all elements of consent. This is made up of IRB-approved wording from the regular consent form. More detailed information, such as specific clinic measures are provided as additional material and are discussed during the consent process after the general overview has been provided with the NEAT form.

NEAT Form

Standard Form OTHER

The regular IRB approved version.

Standard Form

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Individuals who are eligible for the ARIC study, with which this pilot study is cooperating.

You may not qualify if:

• Any individuals not eligible for the ARIC study.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Results Point of Contact

• Title: Joseph E. Andrews, Jr., PhD, CIP, CCRP
• Organization: Wake Forest School of Medicine

jandrews@wakehealth.edu

336-716-7658

Study Officials

• Joseph Andrews, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: February 5, 2018
• Study Start: April 4, 2017
• Primary Completion: May 23, 2017
• Study Completion: May 23, 2017
• Last Updated: October 13, 2023
• Results First Posted: October 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)