Interactive Tool for Informed Consent (I-TIC)

ThinkWell

Status: Withdrawn

Conditions: Informed Consent

Treatments: Behavioral: Intervention B: Questionnaire speed of completion; Behavioral: Intervention C: Questionnaire Completion rate; Behavioral: Intervention A: Questionnaire accuracy

Study type: Interventional

Funder types: Other

Identifiers

NCT02332837

ThinkWell PLOT-03

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups

Digital informed consent

Experimental group

Description:

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

Treatment:

Behavioral: Intervention A: Questionnaire accuracy

Behavioral: Intervention B: Questionnaire speed of completion

Behavioral: Intervention C: Questionnaire Completion rate

Multi-media informed consent

Experimental group

Description:

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

Treatment:

Behavioral: Intervention A: Questionnaire accuracy

Behavioral: Intervention B: Questionnaire speed of completion

Behavioral: Intervention C: Questionnaire Completion rate

Test to train informed consent

Experimental group

Description:

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

Treatment:

Behavioral: Intervention A: Questionnaire accuracy

Behavioral: Intervention B: Questionnaire speed of completion

Behavioral: Intervention C: Questionnaire Completion rate