Consent FormsNCT03416907
Informed Consent Formats by Information Preference and Priority
A study testing Original consent form, Shortened consent form and Reordered, shortened consent form in people with Consent Forms and Asthma, run by Carnegie Mellon University at 1 site in United States.
Trial summary
This study will test whether different formats of medical informed consent documents can help improve understanding and confidence in decision-making for clinical trials. The study will be primarily run through an online survey. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Consent Forms, Asthma
- What is being tested?
- Original consent form, Shortened consent form and Reordered, shortened consent form
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to 31 Dec 2017
- 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
- 18 Years Old or Older
- Read and agreed to informed consent
- Indicated desire to participate
- Diagnosed with asthma
- US resident
Who cannot join
- Participants from whom we receive multiple responses will be dropped from analysis (but will be compensated for participation)
Trial locations and contacts
1 site in 1 country.
United States1 site
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
About this study
This study will test whether different formats of medical informed consent documents can help improve understanding and confidence in decision-making for clinical trials. The study will be primarily run through an online survey.
Read the detailed description
The goal of this study is to investigate whether the same information can be communicated in different formats of an informed consent document in ways that improve participant understanding and confidence. Participants will review one of several different versions of the same informed consent document, and will be asked to complete a survey after reading the documents. The survey will ask participants their willingness to enroll in the clinical trial discussed in the document and their confidence in their decision. The survey will also test participants recollection of information from the informed consent document. Researchers will look at this data to see if there are ways to improve knowledge about the clinical trial and confidence in decisions without necessarily changing enrollment preferences.
- Conditions
- Consent Forms, Asthma
- Being tested
- Original consent form, Shortened consent form, Reordered, shortened consent form, Shortened consent form with a highlights box, Interactive, shortened consent form
- Keywords
- Informed consent
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Original consent formBehavioural
Participants will review the full-length, original consent form for the clinical trial.
Shortened consent formBehavioural
Participants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study.
Reordered, shortened consent formBehavioural
Participants will review a reordered, shortened consent form. This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section).
Shortened consent form with a highlights boxBehavioural
Participants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study.
Interactive, shortened consent formBehavioural
Participants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided. The landing page includes the introductory section.
| Study group | Role | What they receive |
|---|---|---|
| Original | Active comparator | Participants will review the full-length, original consent form for the clinical trial. Receives: Behavioral: Original consent form |
| Shortened | Experimental | Participants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study. Receives: Behavioral: Shortened consent form |
| Reordered | Experimental | Participants will review a reordered, shortened consent form. This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section). Receives: Behavioral: Reordered, shortened consent form |
| Highlighted | Experimental | Participants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study. Receives: Behavioral: Shortened consent form with a highlights box |
| Interactive | Experimental | Participants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided. The landing page includes the introductory section. Receives: Behavioral: Interactive, shortened consent form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score for high impact questions
Sum of correct answers (T/F) for any item relating to material that was rated as 50 or higher on impact on willingness to enroll in a previous study.
Measured: through study completion, an average of 30 minutes
Secondary outcomes (11)
Score for low impact questions
Sum of correct answers (T/F) for any item relating to material that was rated as 49 or lower on impact on willingness to enroll in a previous study.
Measured: through study completion, an average of 30 minutes
Total score for all questions
Sum of correct answers (T/F) on full knowledge test.
Measured: through study completion, an average of 30 minutes
Interaction effect of format and importance on likelihood of correct answer
Interaction effect in a logistic regression predicting a correct answer, based on the format of the consent form and the importance of the answer.
Measured: through study completion, an average of 30 minutes
Scores for different information categories
Sum of correct answers (T/F) for each of the 20 information categories
Measured: through study completion, an average of 30 minutes
Effect of location on score
Logistic regression coefficient of likelihood of predicting a correct answer, based upon the location on which the sentence appeared--uses only the shortened, and the reordered conditions. Note that sentences appearing in the introduction (which is the first section of all treatments) must be dropped, as there will be no variation in location.
Measured: through study completion, an average of 30 minutes
Decision to enroll
Likert measure of participants hypothetical decision to enroll in the study
Measured: through study completion, an average of 30 minutes
Confidence in enrollment decision
Likert measure of participants confidence in hypothetical decision to enroll in the study
Measured: through study completion, an average of 30 minutes
Satisfaction with consent structure
Likert measure of participants satisfaction with the consent form
Measured: through study completion, an average of 30 minutes
Perception of investigator concern for well being
Likert measure of participants belief in the investigator's concerns for the participant's well-being
Measured: through study completion, an average of 30 minutes
Perception of investigator transparency
Likert measure of participants belief that the investigator is trying to communicate information about the trial accurately
Measured: through study completion, an average of 30 minutes
Participant's probability estimate of the likelihood that the treatment would help control their asthma
Survey question of the following form:
'If you enrolled in the trial described in the consent form, what is the probability that the treatment could help control your asthma better, where 0% means "no chance at all of helping" and 100% means "would definitely help"?'
Participants provided with drop-down menu including values from 0% to 100% in increments of 1%.
Measured: through study completion, an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start27 Nov 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consent FormsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- ICON plc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416907
- Sponsor's protocol ID
- STUDY2017_00000268
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Intend to share deidentified participant data, but we want to review the received data to ensure that there is no information that could potentially reveal individual identity that we may not initially anticipate. As such, a clear delineation of what data will be disclosed is not yet available.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informed Consent Formats by Information Preference and Priority
- ClinicalTrials.gov ID
- NCT03416907
- Acronym / sponsor ID
- STUDY2017_00000268
- Conditions
- Consent Forms, Asthma
- Keywords
- Informed consent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- ICON plc
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 31 Jan 2018 (actual)
- 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.
This study will test whether different formats of medical informed consent documents can help improve understanding and confidence in decision-making for clinical trials. The study will be primarily run through an online survey.
Detailed description
The goal of this study is to investigate whether the same information can be communicated in different formats of an informed consent document in ways that improve participant understanding and confidence. Participants will review one of several different versions of the same informed consent document, and will be asked to complete a survey after reading the documents. The survey will ask participants their willingness to enroll in the clinical trial discussed in the document and their confidence in their decision. The survey will also test participants recollection of information from the informed consent document. Researchers will look at this data to see if there are ways to improve knowledge about the clinical trial and confidence in decisions without necessarily changing enrollment preferences.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Original | Active comparator | Behavioral: Original consent formParticipants will review the full-length, original consent form for the clinical trial. |
| Shortened | Experimental | Behavioral: Shortened consent formParticipants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study. |
| Reordered | Experimental | Behavioral: Reordered, shortened consent formParticipants will review a reordered, shortened consent form. This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section). |
| Highlighted | Experimental | Behavioral: Shortened consent form with a highlights boxParticipants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study. |
| Interactive | Experimental | Behavioral: Interactive, shortened consent formParticipants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided. The landing page includes the introductory section. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 Years Old or Older
- Read and agreed to informed consent
- Indicated desire to participate
- Diagnosed with asthma
- US resident
Key exclusion criteria (1 listed)
- Participants from whom we receive multiple responses will be dropped from analysis (but will be compensated for participation)
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 |
|---|---|---|
| Original consent formParticipants will review the full-length, original consent form for the clinical trial. | Behavioural | Original |
| Shortened consent formParticipants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study. | Behavioural | Shortened |
| Reordered, shortened consent formParticipants will review a reordered, shortened consent form. This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section). | Behavioural | Reordered |
| Shortened consent form with a highlights boxParticipants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study. | Behavioural | Highlighted |
| Interactive, shortened consent formParticipants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided. The landing page includes the introductory section. | Behavioural | Interactive |
Primary outcome
Score for high impact questions
Time frame: through study completion, an average of 30 minutes
Sum of correct answers (T/F) for any item relating to material that was rated as 50 or higher on impact on willingness to enroll in a previous study.
11 secondary outcomes
Score for low impact questions
Time frame: through study completion, an average of 30 minutes
Total score for all questions
Time frame: through study completion, an average of 30 minutes
Interaction effect of format and importance on likelihood of correct answer
Time frame: through study completion, an average of 30 minutes
Scores for different information categories
Time frame: through study completion, an average of 30 minutes
Effect of location on score
Time frame: through study completion, an average of 30 minutes
Decision to enroll
Time frame: through study completion, an average of 30 minutes
Confidence in enrollment decision
Time frame: through study completion, an average of 30 minutes
Satisfaction with consent structure
Time frame: through study completion, an average of 30 minutes
Perception of investigator concern for well being
Time frame: through study completion, an average of 30 minutes
Perception of investigator transparency
Time frame: through study completion, an average of 30 minutes
Participant's probability estimate of the likelihood that the treatment would help control their asthma
Time frame: through study completion, an average of 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Individual participant dataSharing planned: Undecided. Intend to share deidentified participant data, but we want to review the received data to ensure that there is no information that could potentially reveal individual identity that we may not initially anticipate. As such, a clear delineation of what data will be disclosed is not yet available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Original consent form, Shortened consent form and Reordered, shortened consent form in people with Consent Forms and Asthma, run by Carnegie Mellon University at 1 site in United States.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score for high impact questions (time frame: through study completion, an average of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2018.