Consent FormsNCT02489682
Clinical Informed Consent Format Evaluation
A study testing Long-form written Informed consent information, Short-form written Informed consent information and Video Informed consent information in people with Consent Forms, run by Carnegie Mellon University.
Trial summary
This study evaluates the effectiveness of a patient-centered short written informed consent form and a patient-centered short video informed consent in a randomized controlled trial (control = traditional informed consent ). 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
- What is being tested?
- Long-form written Informed consent information, Short-form written Informed consent information and Video Informed consent information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to May 2015
- 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
- at least 18 years of age
- fluent in English
- self-identifying as asthma patients
Who cannot join
None listed.
About this study
This study evaluates the effectiveness of a patient-centered short written informed consent form and a patient-centered short video informed consent in a randomized controlled trial (control = traditional informed consent ). Primary outcome measures include critical knowledge acquisition, risk and benefit judgments, and desired enrollment in a hypothetical clinical trial. The investigators hypothesized that the patient-centered patient-designed consent forms (video and written format) would do as well as or outperform the traditional consent form on the primary outcomes.
Read the detailed description
Traditional informed consent documents tend to be lengthy and technical, often too dense to facilitate proper patient-engagement. In this study, the investigators test the effectiveness of a previously developed patient-centered, short informed consent document and a patient-centered, short informed animated consent video as compared to a lengthy traditional informed consent document for the same clinical condition (i.e. severe asthma)
In this study, self-identified asthma patients, aged 18 or older, attending an experimental session in a university computer laboratory will be randomly assigned to read either the full informed consent document (control) or the short, patient-centered informed consent document or to view the short patient-centered informed consent video. Participants will also complete a follow-up survey at 1-week.
The main outcome measures are:
Engagement in the information (1=not at all engaged, 2=not very engaged, 3= somewhat engaged, 4=very engaged, 5=completely engaged).
Intention to enroll in the clinical trial
(1=definitely would not, 3=neutral, and 5=definitely would)
Trial knowledge (12 multiple choice questions, e.g. ""When can [the participants] withdraw from the trial?")
Trust in the clinical trial physician (Six questions beginning with, "If [the participant] decided to enroll in this study, how much would [the participant] trust Dr. Janet Taylor, the physician who is leading the study, to...")
Perceived risks and benefits of the trial (Four questions, e.g. "Imagine that [the participant] enrolled in the clinical trial, how likely do [the participants] think it is that the drug would be more effective in treating [the participant's] asthma symptoms than an average asthma drug on the market?")
The investigators hypothesize that the two experimental conditions will outperform the control condition on engagement and trial knowledge and would do as well as the control on the remaining outcome measures.
- Conditions
- Consent Forms
- Being tested
- Long-form written Informed consent information, Short-form written Informed consent information, Video Informed consent information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-form written Informed consent informationOther
Short-form written Informed consent informationOther
Video Informed consent informationOther
| Study group | Role | What they receive |
|---|---|---|
| Informed Consent Format - short written | Experimental | Intervention to be administered:
- Short-form written informed consent information, followed immediately by outcomes questionnaire Receives: Other: Short-form written Informed consent information |
| Informed Consent Format - long written | Experimental | Intervention to be administered:
- Long-form written informed consent information, followed immediately by outcomes questionnaire Receives: Other: Long-form written Informed consent information |
| Informed Consent Format - video | Experimental | Intervention to be administered:
- Video informed consent information, followed immediately by outcomes questionnaire Receives: Other: Video Informed consent information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothetical trial enrollment as assessed by a likelihood of enrollment question
Measured: immediately after intervention
Engagement as assessed by a likert scale engagement question
Measured: immediately after intervention
Trust in physician as assessed by a composite of likert scale questions measuring trust
Measured: immediately after intervention
Trial Knowledge as assessed by a composite of 12 true/false questions
Measured: immediately after intervention
Perceived Risk and Benefit as assessed by a series of judgment questions
Measured: immediately after intervention
Secondary outcomes (4)
Change in hypothetical trial enrollment as assessed by a likelihood of enrollment question at 1 week from intervention
Measured: 1-week follow-up
Change in trust in physician as assessed by a composite of likert scale questions measuring trust at 1 week from intervention
Measured: 1-week follow-up
Change in hypothetical trial trial knowledge as assessed by a composite of 12 true/false questions at 1 week from intervention
Measured: 1-week follow-up
Change in Perceived Risk and Benefit as assessed by a series of judgment questions at 1 week from intervention
Measured: 1-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionMay 2015
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- ICON plc
- Responsible party
- Principal investigator, Tamar Krishnamurti, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489682
- Sponsor's protocol ID
- A016520
- Status last verified
- Feb 2024
- First submitted
- 24 Jun 2015
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Informed Consent Format Evaluation
- ClinicalTrials.gov ID
- NCT02489682
- Acronym / sponsor ID
- A016520
- Conditions
- Consent Forms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- ICON plc
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Jul 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.
This study evaluates the effectiveness of a patient-centered short written informed consent form and a patient-centered short video informed consent in a randomized controlled trial (control = traditional informed consent ). Primary outcome measures include critical knowledge acquisition, risk and benefit judgments, and desired enrollment in a hypothetical clinical trial. The investigators hypothesized that the patient-centered patient-designed consent forms (video and written format) would do as well as or outperform the traditional consent form on the primary outcomes.
Detailed description
Traditional informed consent documents tend to be lengthy and technical, often too dense to facilitate proper patient-engagement. In this study, the investigators test the effectiveness of a previously developed patient-centered, short informed consent document and a patient-centered, short informed animated consent video as compared to a lengthy traditional informed consent document for the same clinical condition (i.e. severe asthma)
In this study, self-identified asthma patients, aged 18 or older, attending an experimental session in a university computer laboratory will be randomly assigned to read either the full informed consent document (control) or the short, patient-centered informed consent document or to view the short patient-centered informed consent video. Participants will also complete a follow-up survey at 1-week.
The main outcome measures are:
Engagement in the information (1=not at all engaged, 2=not very engaged, 3= somewhat engaged, 4=very engaged, 5=completely engaged).
Intention to enroll in the clinical trial
(1=definitely would not, 3=neutral, and 5=definitely would)
Trial knowledge (12 multiple choice questions, e.g. ""When can [the participants] withdraw from the trial?")
Trust in the clinical trial physician (Six questions beginning with, "If [the participant] decided to enroll in this study, how much would [the participant] trust Dr. Janet Taylor, the physician who is leading the study, to...")
Perceived risks and benefits of the trial (Four questions, e.g. "Imagine that [the participant] enrolled in the clinical trial, how likely do [the participants] think it is that the drug would be more effective in treating [the participant's] asthma symptoms than an average asthma drug on the market?")
The investigators hypothesize that the two experimental conditions will outperform the control condition on engagement and trial knowledge and would do as well as the control on the remaining outcome measures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Informed Consent Format - short written | Experimental | Other: Short-form written Informed consent informationIntervention to be administered: - Short-form written informed consent information, followed immediately by outcomes questionnaire |
| Informed Consent Format - long written | Experimental | Other: Long-form written Informed consent informationIntervention to be administered: - Long-form written informed consent information, followed immediately by outcomes questionnaire |
| Informed Consent Format - video | Experimental | Other: Video Informed consent informationIntervention to be administered: - Video informed consent information, followed immediately by outcomes questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years of age
- fluent in English
- self-identifying as asthma patients
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Long-form written Informed consent information | Other | Informed Consent Format - long written |
| Short-form written Informed consent information | Other | Informed Consent Format - short written |
| Video Informed consent information | Other | Informed Consent Format - video |
Primary outcome
Hypothetical trial enrollment as assessed by a likelihood of enrollment question
Time frame: immediately after intervention
Engagement as assessed by a likert scale engagement question
Time frame: immediately after intervention
Trust in physician as assessed by a composite of likert scale questions measuring trust
Time frame: immediately after intervention
Trial Knowledge as assessed by a composite of 12 true/false questions
Time frame: immediately after intervention
Perceived Risk and Benefit as assessed by a series of judgment questions
Time frame: immediately after intervention
4 secondary outcomes
Change in hypothetical trial enrollment as assessed by a likelihood of enrollment question at 1 week from intervention
Time frame: 1-week follow-up
Change in trust in physician as assessed by a composite of likert scale questions measuring trust at 1 week from intervention
Time frame: 1-week follow-up
Change in hypothetical trial trial knowledge as assessed by a composite of 12 true/false questions at 1 week from intervention
Time frame: 1-week follow-up
Change in Perceived Risk and Benefit as assessed by a series of judgment questions at 1 week from intervention
Time frame: 1-week follow-up
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 6 Feb 2024.
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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 Long-form written Informed consent information, Short-form written Informed consent information and Video Informed consent information in people with Consent Forms, run by Carnegie Mellon University.
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 0 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 6 Feb 2024. 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 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?
Hypothetical trial enrollment as assessed by a likelihood of enrollment question (time frame: immediately after intervention). The study lists 5 primary outcomes in all. 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 6 Feb 2024; AzTrials last refreshed its copy on 30 Oct 2026.