NCT02332837

Brief Summary

Online trials require informed consent from participants. Massive online trials make face-to-face signed consent unrealistic and existing consent comprehension could be improved to increase participant safety and understanding. This trial will compare understanding of traditional digital consent with multi-media consent and with consent that is multi-media and interactive and uses a test and train model. The computer will assign participants to 1 of 3 methods to present online consent to participants

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 Jul 2019

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withdrawn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

January 4, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
4.5 years until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

January 4, 2015

Last Update Submit

March 18, 2021

Conditions

Informed Consent

Keywords

informed consent, public led trials, shared decision making,

Outcome Measures

Primary Outcomes (1)

  • level of consent comprehension

    assessed by accuracy on scored questionnaire

    immediately following intervention

Secondary Outcomes (2)

  • Time to complete consent

    immediately following intervention

  • Compliance

    immediately following intervention

Study Arms (3)

Digital informed consent

EXPERIMENTAL

Traditional digitally signed text based informed consent Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate

Behavioral: Intervention A: Questionnaire accuracyBehavioral: Intervention B: Questionnaire speed of completionBehavioral: Intervention C: Questionnaire Completion rate

Multi-media informed consent

EXPERIMENTAL

Informed consent with images, text and auditory presentation Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate

Behavioral: Intervention A: Questionnaire accuracyBehavioral: Intervention B: Questionnaire speed of completionBehavioral: Intervention C: Questionnaire Completion rate

Test to train informed consent

EXPERIMENTAL

Informed consent with images, text, auditory presentation and test to train feature where participants get feedback on comprehension responses throughout the consent and can change them Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate

Behavioral: Intervention A: Questionnaire accuracyBehavioral: Intervention B: Questionnaire speed of completionBehavioral: Intervention C: Questionnaire Completion rate

Interventions

Intervention A: Questionnaire accuracyBEHAVIORAL

Participants will be tested by questionnaire to measure how well consent is understood

Digital informed consentMulti-media informed consentTest to train informed consent
Intervention B: Questionnaire speed of completionBEHAVIORAL

Time to complete questionnaire from time of presentation

Digital informed consentMulti-media informed consentTest to train informed consent
Intervention C: Questionnaire Completion rateBEHAVIORAL

Number of participants who complete the questionnaire

Digital informed consentMulti-media informed consentTest to train informed consent

Eligibility Criteria

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

You may qualify if:

  • pre-screened as eligible for a ThinkWell PLOT trial
  • years of age
  • No personal email address

You may not qualify if:

  • not pre-screened or eligible for an existing ThinkWell PLOT trial
  • people without internet access
  • People who cannot read
  • People without the ability to understand the website and informed consent documents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Ryan RE, Prictor MJ, McLaughlin KJ, Hill SJ. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD003717. doi: 10.1002/14651858.CD003717.pub2.

    PMID: 18254029BACKGROUND

  • Gillies K, Huang W, Skea Z, Brehaut J, Cotton S. Patient information leaflets (PILs) for UK randomised controlled trials: a feasibility study exploring whether they contain information to support decision making about trial participation. Trials. 2014 Feb 18;15:62. doi: 10.1186/1745-6215-15-62.

    PMID: 24548781BACKGROUND

  • Antoniou EE, Draper H, Reed K, Burls A, Southwood TR, Zeegers MP. An empirical study on the preferred size of the participant information sheet in research. J Med Ethics. 2011 Sep;37(9):557-62. doi: 10.1136/jme.2010.041871. Epub 2011 Apr 8.

    PMID: 21478421BACKGROUND

  • Rowbotham MC, Astin J, Greene K, Cummings SR. Interactive informed consent: randomized comparison with paper consents. PLoS One. 2013;8(3):e58603. doi: 10.1371/journal.pone.0058603. Epub 2013 Mar 6.

    PMID: 23484041BACKGROUND
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2015

First Posted

January 7, 2015

Study Start

July 1, 2019

Primary Completion

November 1, 2019

Study Completion

June 1, 2020

Last Updated

March 23, 2021

Record last verified: 2021-03