NCT02799407

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
2.4 years until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

April 12, 2024

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

June 6, 2016

Last Update Submit

April 11, 2024

Conditions

Informed Consent

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Traditional Long Form Consent

NO INTERVENTION

Participants will receive the traditional long-form consent form.

ResearchKit Consent

EXPERIMENTAL

Participants will receive the Apple ResearchKit consent form.

Other: ResearchKit Consent

Interventions

ResearchKit ConsentOTHER

Multi-tiered consent form using the Apple ResearchKit Platform.

ResearchKit Consent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • David Tanaka, MD

    Duke Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 14, 2016

Study Start

November 1, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

April 12, 2024

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share