The New Executive and Appendix Template (NEAT) Study

Wake Forest University (WFU)

Status: Completed

Conditions: Informed Consent; Comprehension

Treatments: Other: Standard Form; Other: NEAT Form

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03419832

5UL1TR001420-03 (U.S. NIH Grant/Contract)

IRB00031904

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

NEAT Form

Experimental group

Description:

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

Treatment:

Other: NEAT Form

Standard Form

Active Comparator group

Description:

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

Treatment:

Other: Standard Form