An interventional study of Intervention A: Questionnaire accuracy and Intervention B: Questionnaire speed of completion in Informed Consent, sponsored by ThinkWell. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-23.
Sponsored by ThinkWell · Not applicable, Interventional, and Other
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
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
ThinkWell is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Behavioral: Intervention B: Questionnaire speed of completion · Behavioral: Intervention C: Questionnaire Completion rate
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 · Behavioral: Intervention B: Questionnaire speed of completion · Behavioral: Intervention C: Questionnaire Completion rate
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 · Behavioral: Intervention B: Questionnaire speed of completion · Behavioral: Intervention C: Questionnaire Completion rate
Participants will be tested by questionnaire to measure how well consent is understood
Time to complete questionnaire from time of presentation
Number of participants who complete the questionnaire
level of consent comprehension
assessed by accuracy on scored questionnaire
Time frame: immediately following intervention
Time to complete consent
Time between presentation of consent materials and signing of consent
Time frame: immediately following intervention
Compliance
number of participants who complete consent questionnaire
Time frame: immediately following intervention
No study locations are listed for this record.
Start is estimated for Jul 2019; primary completion for Nov 2019, 4 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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