Trial Outcomes & Findings for The New Executive and Appendix Template (NEAT) Study (NCT NCT03419832)
NCT ID: NCT03419832
Last Updated: 2023-10-13
Results Overview
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.
COMPLETED
NA
101 participants
at visit one, up to 24 hours
2023-10-13
Participant Flow
Participant milestones
| Measure |
NEAT Form
Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).
NEAT Form: 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.
|
Standard Form
Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).
Standard Form: The regular IRB approved version.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
49
|
|
Overall Study
COMPLETED
|
52
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gender baseline characteristic data was not collected for this study.
Baseline characteristics by cohort
| Measure |
NEAT Form
n=52 Participants
Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).
NEAT Form: 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.
|
Standard Form
n=49 Participants
Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).
Standard Form: The regular IRB approved version.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Aged 65 or older
|
52 Participants
n=52 Participants
|
49 Participants
n=49 Participants
|
101 Participants
n=101 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
0 Participants
Gender baseline characteristic data was not collected for this study.
|
|
Sex: Female, Male
Male
|
—
|
—
|
0 Participants
Gender baseline characteristic data was not collected for this study.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: at visit one, up to 24 hoursFollowing 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.
Outcome measures
| Measure |
Standard Form
n=49 Participants
Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).
Standard Form: The regular IRB approved version.
|
NEAT Form
n=52 Participants
Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).
NEAT Form: 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.
|
|---|---|---|
|
Comprehension of the NEAT Form
|
10.2 score on a scale
Standard Deviation 2.5
|
10.6 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: at visit one, up to 24 hoursPopulation: Two people did not complete this question in the Standard Form Arm
Subjects were asked about the readability and understandability of the consent form and selected responses from the following options: Much easier to read and understand, Somewhat easier to read and understand, About the same, or Harder/Much harder to read and understand. The frequency of each response was reported.
Outcome measures
| Measure |
Standard Form
n=47 Participants
Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).
Standard Form: The regular IRB approved version.
|
NEAT Form
n=52 Participants
Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).
NEAT Form: 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.
|
|---|---|---|
|
Qualitative Analysis of the Readability and Understandability of the Consent Form by Participants
Much easier to read and understand
|
9 number of each response
|
18 number of each response
|
|
Qualitative Analysis of the Readability and Understandability of the Consent Form by Participants
Somewhat easier to read and understand
|
9 number of each response
|
12 number of each response
|
|
Qualitative Analysis of the Readability and Understandability of the Consent Form by Participants
About the same
|
24 number of each response
|
19 number of each response
|
|
Qualitative Analysis of the Readability and Understandability of the Consent Form by Participants
Harder/Much harder to read and understandBottom of Form
|
5 number of each response
|
3 number of each response
|
SECONDARY outcome
Timeframe: at visit one, up to 24 hoursPopulation: Two people did not complete this question in the Standard Form Arm.
Subjects were asked about the format and design of the consent form and selected from the following options: Much better format and design, Somewhat better format and design, About the same format and design, or Somewhat worse format and design. The frequency of each response was reported.
Outcome measures
| Measure |
Standard Form
n=47 Participants
Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).
Standard Form: The regular IRB approved version.
|
NEAT Form
n=52 Participants
Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).
NEAT Form: 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.
|
|---|---|---|
|
Qualitative Analysis of the Format and Design of the Consent Form by Participants
Much better format and design
|
13 number of each response
|
14 number of each response
|
|
Qualitative Analysis of the Format and Design of the Consent Form by Participants
Somewhat better format and design
|
14 number of each response
|
22 number of each response
|
|
Qualitative Analysis of the Format and Design of the Consent Form by Participants
About the same format and design
|
18 number of each response
|
16 number of each response
|
|
Qualitative Analysis of the Format and Design of the Consent Form by Participants
Somewhat worse format and design
|
2 number of each response
|
0 number of each response
|
SECONDARY outcome
Timeframe: at visit one, up to 24 hoursPopulation: Two people did not complete this question in the Standard Form Arm.
Subjects were asked about the time of discussion of the consent form and selected from following options: Much shorter time, Somewhat shorter time, About the same time, or Somewhat/Much longer time. The frequency of each response was reported.
Outcome measures
| Measure |
Standard Form
n=47 Participants
Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).
Standard Form: The regular IRB approved version.
|
NEAT Form
n=52 Participants
Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).
NEAT Form: 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.
|
|---|---|---|
|
Qualitative Analysis of the Time of Discussion of the Consent Form by Participants
Much shorter time
|
9 number of each response
|
9 number of each response
|
|
Qualitative Analysis of the Time of Discussion of the Consent Form by Participants
Somewhat shorter time
|
9 number of each response
|
16 number of each response
|
|
Qualitative Analysis of the Time of Discussion of the Consent Form by Participants
About the same time
|
13 number of each response
|
18 number of each response
|
|
Qualitative Analysis of the Time of Discussion of the Consent Form by Participants
Somewhat/Much longer time
|
16 number of each response
|
9 number of each response
|
SECONDARY outcome
Timeframe: at visit one, up to 24 hoursPopulation: Data not collected for this outcome. No data to report.
The study team member qualitative data about their opinion of using the form will be collected. Study team members were asked about the format and design of the consent form and selected from the following options: Much better format and design, Somewhat better format and design, About the same format and design, or Somewhat worse format and design. The frequency of each response was reported.
Outcome measures
Outcome data not reported
Adverse Events
NEAT Form
Standard Form
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joseph E. Andrews, Jr., PhD, CIP, CCRP
Wake Forest School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place