Clinical Informed Consent Format Evaluation
1 other identifier
interventional
76
0 countries
N/A
Brief 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 ). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2014
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 24, 2015
CompletedFirst Posted
Study publicly available on registry
July 3, 2015
CompletedFebruary 6, 2024
February 1, 2024
4 months
June 24, 2015
February 5, 2024
Conditions
Outcome Measures
Primary Outcomes (5)
Hypothetical trial enrollment as assessed by a likelihood of enrollment question
immediately after intervention
Engagement as assessed by a likert scale engagement question
immediately after intervention
Trust in physician as assessed by a composite of likert scale questions measuring trust
immediately after intervention
Trial Knowledge as assessed by a composite of 12 true/false questions
immediately after intervention
Perceived Risk and Benefit as assessed by a series of judgment questions
immediately after intervention
Secondary Outcomes (4)
Change in hypothetical trial enrollment as assessed by a likelihood of enrollment question at 1 week from intervention
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
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
1-week follow-up
Change in Perceived Risk and Benefit as assessed by a series of judgment questions at 1 week from intervention
1-week follow-up
Study Arms (3)
Informed Consent Format - short written
EXPERIMENTALIntervention to be administered: \- Short-form written informed consent information, followed immediately by outcomes questionnaire
Informed Consent Format - long written
EXPERIMENTALIntervention to be administered: \- Long-form written informed consent information, followed immediately by outcomes questionnaire
Informed Consent Format - video
EXPERIMENTALIntervention to be administered: \- Video informed consent information, followed immediately by outcomes questionnaire
Interventions
Eligibility Criteria
You may qualify if:
- at least 18 years of age
- fluent in English
- self-identifying as asthma patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carnegie Mellon Universitylead
- ICON plccollaborator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
June 24, 2015
First Posted
July 3, 2015
Study Start
December 1, 2014
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
February 6, 2024
Record last verified: 2024-02