Interactive Tool for Informed Consent

Informed Consent Clinical Trial

— I-TIC  

Official title:

Interactive Tool for Informed Consent: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02332837
• Other study ID #: ThinkWell PLOT-03
• Status: Withdrawn
• Phase: N/A
• Start date: July 2019
• Est. completion date: June 2020

Study information

• Verified date: March 2021
• Source: ThinkWell
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Informed Consent

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ThinkWell

References & Publications (4)

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. — View 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. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2014;5:CD003717. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of consent comprehension	assessed by accuracy on scored questionnaire	immediately following intervention
Secondary	Time to complete consent	Time between presentation of consent materials and signing of consent	immediately following intervention
Secondary	Compliance	number of participants who complete consent questionnaire	immediately following intervention