Informed Consent Formats by Information Preference and Priority
1 other identifier
interventional
500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedFirst Submitted
Initial submission to the registry
January 8, 2018
CompletedFirst Posted
Study publicly available on registry
January 31, 2018
CompletedJanuary 31, 2018
January 1, 2018
1 month
January 8, 2018
January 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
through study completion, an average of 30 minutes
Secondary Outcomes (11)
Score for low impact questions
through study completion, an average of 30 minutes
Total score for all questions
through study completion, an average of 30 minutes
Interaction effect of format and importance on likelihood of correct answer
through study completion, an average of 30 minutes
Scores for different information categories
through study completion, an average of 30 minutes
Effect of location on score
through study completion, an average of 30 minutes
- +6 more secondary outcomes
Other Outcomes (1)
Participant's free-response text describing what was learned from reading the informed consent document
through study completion, an average of 30 minutes
Study Arms (5)
Original
ACTIVE COMPARATORParticipants will review the full-length, original consent form for the clinical trial.
Shortened
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Participants will review the full-length, original consent form for the clinical trial.
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.
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).
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.
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.
Eligibility Criteria
You may qualify if:
- Years Old or Older
- Read and agreed to informed consent
- Indicated desire to participate
- Diagnosed with asthma
- US resident
You may not qualify if:
- Participants from whom we receive multiple responses will be dropped from analysis (but will be compensated for participation)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carnegie Mellon Universitylead
- ICON plccollaborator
Study Sites (1)
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2018
First Posted
January 31, 2018
Study Start
November 27, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
January 31, 2018
Record last verified: 2018-01