Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2019-07-31
2020-06-30
Brief Summary
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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
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Detailed Description
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Without accurate knowledge decision-making is not informed. Informed consent for participation in research is part of this process. In online trials the opportunity for face-to-face signed consent with researchers is not an option.
Consent acts as a safeguard that full disclosure occurred. Adequate documentation is evidence against false reports of coercion.
Informed consent inclusive of signed participant information sheets provide a record between researcher and participant of the roles and agreements they share.
According to existing research, only 6% of consents and participant information sheets are written below an eighth grade level of comprehension; 54% of participants with an 8th grade level education partially understood the consent with figures rising to 72% for participants with greater than 8th grade educations, however no participant fully understood the consent materials. The deficits ranged from misunderstandings about risk, side effects, adverse effects reporting, a participants right to withdraw, confidentiality and even the purpose of the trial.
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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Digital informed consent
Traditional digitally signed text based informed consent
Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate
Intervention A: Questionnaire accuracy
Participants will be tested by questionnaire to measure how well consent is understood
Intervention B: Questionnaire speed of completion
Time to complete questionnaire from time of presentation
Intervention C: Questionnaire Completion rate
Number of participants who complete the questionnaire
Multi-media informed consent
Informed consent with images, text and auditory presentation
Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate
Intervention A: Questionnaire accuracy
Participants will be tested by questionnaire to measure how well consent is understood
Intervention B: Questionnaire speed of completion
Time to complete questionnaire from time of presentation
Intervention C: Questionnaire Completion rate
Number of participants who complete the questionnaire
Test to train informed consent
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
Intervention A: Questionnaire accuracy
Participants will be tested by questionnaire to measure how well consent is understood
Intervention B: Questionnaire speed of completion
Time to complete questionnaire from time of presentation
Intervention C: Questionnaire Completion rate
Number of participants who complete the questionnaire
Interventions
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Intervention A: Questionnaire accuracy
Participants will be tested by questionnaire to measure how well consent is understood
Intervention B: Questionnaire speed of completion
Time to complete questionnaire from time of presentation
Intervention C: Questionnaire Completion rate
Number of participants who complete the questionnaire
Eligibility Criteria
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Inclusion Criteria
* 18 years of age
* No personal email address
Exclusion Criteria
* people without internet access
* People who cannot read
* People without the ability to understand the website and informed consent documents
18 Years
ALL
Yes
Sponsors
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ThinkWell
OTHER
Responsible Party
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References
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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.
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.
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.
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.
Other Identifiers
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ThinkWell PLOT-03
Identifier Type: -
Identifier Source: org_study_id
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