Electronic Consent of Numerous Subjects Employing Novel Techniques Trial

Informed Consent Clinical Trial

— ECONSENT  

Official title:

Electronic Consent of Numerous Subjects Employing Novel Techniques Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02799407
• Other study ID #: Pro00070430
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: May 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form.

Description:

The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form. Through this two-arm randomized controlled trial (RCT) 120 participants will be asked to read through either a ResearchKit multi-tiered consent form administered on an iPod Touch device or a standard long-form consent form administered via paper and give their informed consent for a sham research study on health tracking apps. The participants will then be asked to answer a short series of questions (5 minutes) about the consent process in order to measure their subjective and objective comprehension. The main risk from this study is loss of confidentiality of responses, however this risk should be minimal given that protected health information (PHI) will only be collected on the consent document and all information will be stored on Duke Box in a private folder only accessible by the study team.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years
• Able to read and understand study materials which are presented in English
• Owns or has access to a smartphone or other smart device such as a tablet or iPod

Exclusion Criteria:

• Any physical limitations which prevent the participant from using mobile and/or touch screen technologies
• Employed in a research position, clinical care position, or position which has regular exposure to clinical research

Related Conditions & MeSH terms

• Informed Consent

Intervention

Other:
• ResearchKit Consent
Multi-tiered consent form using the Apple ResearchKit Platform.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant comprehension, as measured by Qualtrics survey	Participants will complete a questionnaire about the consent form after reading through the consent which will assess their comprehension of the contents of the consent process.	at study conclusion, an average of 15 minutes