Informed ConsentI-TICNCT02332837
Interactive Tool for Informed Consent
A study testing Intervention A: Questionnaire accuracy, Intervention B: Questionnaire speed of completion and Intervention C: Questionnaire Completion rate in people with Informed Consent, run by ThinkWell.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Informed Consent
- What is being tested?
- Intervention A: Questionnaire accuracy, Intervention B: Questionnaire speed of completion and Intervention C: Questionnaire Completion rate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pre-screened as eligible for a ThinkWell PLOT trial
- 18 years of age
- No personal email address
Who cannot join
- 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
About this study
Official title: Interactive Tool for Informed Consent: A Randomized Controlled Trial
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
Read the 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
- Conditions
- Informed Consent
- Being tested
- Intervention A: Questionnaire accuracy, Intervention B: Questionnaire speed of completion, Intervention C: Questionnaire Completion rate
- Keywords
- informed consent, public led trials, shared decision making,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention A: Questionnaire accuracyBehavioural
Participants will be tested by questionnaire to measure how well consent is understood
Intervention B: Questionnaire speed of completionBehavioural
Time to complete questionnaire from time of presentation
Intervention C: Questionnaire Completion rateBehavioural
Number of participants who complete the questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Digital informed consent | Experimental | Traditional digitally signed text based informed consent
Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate Receives: Behavioral: Intervention A: Questionnaire accuracy; Behavioral: Intervention B: Questionnaire speed of completion; Behavioral: Intervention C: Questionnaire Completion rate |
| Multi-media informed consent | Experimental | Informed consent with images, text and auditory presentation
Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate Receives: Behavioral: Intervention A: Questionnaire accuracy; Behavioral: Intervention B: Questionnaire speed of completion; Behavioral: Intervention C: Questionnaire Completion rate |
| Test to train informed consent | Experimental | 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 Receives: Behavioral: Intervention A: Questionnaire accuracy; Behavioral: Intervention B: Questionnaire speed of completion; Behavioral: Intervention C: Questionnaire Completion rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of consent comprehension
assessed by accuracy on scored questionnaire
Measured: immediately following intervention
Secondary outcomes (2)
Time to complete consent
Time between presentation of consent materials and signing of consent
Measured: immediately following intervention
Compliance
number of participants who complete consent questionnaire
Measured: immediately following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJul 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: Not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Informed ConsentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThinkWell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332837
- Sponsor's protocol ID
- ThinkWell PLOT-03
- Acronym
- I-TIC
- Status last verified
- Mar 2021
- First submitted
- 4 Jan 2015
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18254029Gillies 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.
PubMed 24548781Antoniou 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.
PubMed 21478421Rowbotham 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.
PubMed 23484041
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Tool for Informed Consent: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02332837
- Acronym / sponsor ID
- I-TIC / ThinkWell PLOT-03
- Conditions
- Informed Consent
- Keywords
- informed consent, public led trials, shared decision making,
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ThinkWellUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Digital informed consent | Experimental | Behavioral: Intervention A: Questionnaire accuracy, Behavioral: Intervention B: Questionnaire speed of completion, Behavioral: Intervention C: Questionnaire Completion rateTraditional digitally signed text based informed consent Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate |
| Multi-media informed consent | Experimental | Behavioral: Intervention A: Questionnaire accuracy, Behavioral: Intervention B: Questionnaire speed of completion, Behavioral: Intervention C: Questionnaire Completion rateInformed consent with images, text and auditory presentation Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate |
| Test to train informed consent | Experimental | Behavioral: Intervention A: Questionnaire accuracy, Behavioral: Intervention B: Questionnaire speed of completion, Behavioral: Intervention C: Questionnaire Completion rateInformed 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pre-screened as eligible for a ThinkWell PLOT trial
- 18 years of age
- No personal email address
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention A: Questionnaire accuracyParticipants will be tested by questionnaire to measure how well consent is understood | Behavioural | Digital informed consent, Multi-media informed consent, Test to train informed consent |
| Intervention B: Questionnaire speed of completionTime to complete questionnaire from time of presentation | Behavioural | Digital informed consent, Multi-media informed consent, Test to train informed consent |
| Intervention C: Questionnaire Completion rateNumber of participants who complete the questionnaire | Behavioural | Digital informed consent, Multi-media informed consent, Test to train informed consent |
Primary outcome
level of consent comprehension
Time frame: immediately following intervention
assessed by accuracy on scored questionnaire
2 secondary outcomes
Time to complete consent
Time frame: immediately following intervention
Compliance
Time frame: immediately following intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background: PubMed 18254029Ryan 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.
- Background: PubMed 24548781Gillies 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.
- Background: PubMed 21478421Antoniou 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.
- Background: PubMed 23484041Rowbotham 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention A: Questionnaire accuracy, Intervention B: Questionnaire speed of completion and Intervention C: Questionnaire Completion rate in people with Informed Consent, run by ThinkWell.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of consent comprehension (time frame: immediately following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02332837, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.