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Interactive Tool for Informed Consent (I-TIC)

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ClinicalTrials.gov Identifier: NCT02332837
Recruitment Status : Not yet recruiting
First Posted : January 7, 2015
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
ThinkWell

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


Condition or disease Intervention/treatment Phase
Informed Consent Behavioral: Intervention A: Questionnaire accuracy Behavioral: Intervention B: Questionnaire speed of completion Behavioral: Intervention C: Questionnaire Completion rate Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Interactive Tool for Informed Consent: A Randomized Controlled Trial
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: 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

Behavioral: Intervention A: Questionnaire accuracy
Participants will be tested by questionnaire to measure how well consent is understood

Behavioral: Intervention B: Questionnaire speed of completion
Time to complete questionnaire from time of presentation

Behavioral: Intervention C: Questionnaire Completion rate
Number of participants who complete the questionnaire

Experimental: 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

Behavioral: Intervention A: Questionnaire accuracy
Participants will be tested by questionnaire to measure how well consent is understood

Behavioral: Intervention B: Questionnaire speed of completion
Time to complete questionnaire from time of presentation

Behavioral: Intervention C: Questionnaire Completion rate
Number of participants who complete the questionnaire

Experimental: 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

Behavioral: Intervention A: Questionnaire accuracy
Participants will be tested by questionnaire to measure how well consent is understood

Behavioral: Intervention B: Questionnaire speed of completion
Time to complete questionnaire from time of presentation

Behavioral: Intervention C: Questionnaire Completion rate
Number of participants who complete the questionnaire




Primary Outcome Measures :
  1. level of consent comprehension [ Time Frame: immediately following intervention ]
    assessed by accuracy on scored questionnaire


Secondary Outcome Measures :
  1. Time to complete consent [ Time Frame: immediately following intervention ]
    Time between presentation of consent materials and signing of consent

  2. Compliance [ Time Frame: immediately following intervention ]
    number of participants who complete consent questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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