Electronic Consent of Numerous Subjects Employing Novel Techniques Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Informed Consent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Traditional Long Form Consent

Participants will receive the traditional long-form consent form.

Group Type NO_INTERVENTION

No interventions assigned to this group

ResearchKit Consent

Participants will receive the Apple ResearchKit consent form.

Group Type EXPERIMENTAL

ResearchKit Consent

Intervention Type OTHER

Multi-tiered consent form using the Apple ResearchKit Platform.

Interventions

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ResearchKit Consent

Multi-tiered consent form using the Apple ResearchKit Platform.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes