Clinical trial NCT02332837: Interactive Tool for Informed Consent
Official title: Interactive Tool for Informed Consent: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Informed Consent
Keywords: informed consent, public led trials, shared decision making,
Lead sponsor: ThinkWell
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Detailed description: 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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: level of consent comprehension
timeFrame: immediately following intervention
Secondary outcomes:
measure: Time to complete consent
timeFrame: immediately following intervention
measure: Compliance
timeFrame: immediately following intervention
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.