Electronic Consent of Numerous Subjects Employing Novel Techniques Trial (ECONSENT)

April 11, 2024 updated by: Duke University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Traditional Long Form Consent
Participants will receive the traditional long-form consent form.
Experimental: ResearchKit Consent
Participants will receive the Apple ResearchKit consent form.
Other: ResearchKit Consent
Multi-tiered consent form using the Apple ResearchKit Platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant comprehension, as measured by Qualtrics survey
Time Frame: at study conclusion, an average of 15 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: David Tanaka, MD, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2018

Primary Completion (Estimated)

August 1, 2019

Study Completion (Estimated)

August 1, 2019

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimated)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00070430

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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