Track topics on Twitter Track topics that are important to you
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 our primary outcomes.
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Long-form written Informed consent information, Short-form written Informed consent information, Video Informed consent information
Carnegie Mellon University
Published on BioPortfolio: 2015-07-07T09:08:23-0400
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...
The purpose of this study is to test an interactive multimedia informed consent (iMIC) computer program to see if the program can generate a consent form that potential participants in an ...
This is a sub-study of a drug development study conducted by Pfizer, Inc. It will evaluate how well people who participate in research studies understand from the study consent form what t...
There is evidence that the current design and content provided by most biomedical research informed consent documents do not consistently meet the expectations researchers place on them to...
Well-informed potential subjects are presumably better able to make autonomous decisions about the risks and benefits of participating in a research study than those in possession of less ...
To make an informed choice to participate in a genome sequencing study that may yield primary and secondary findings, one understands relevant information in the context of personal values. Consent fo...
Due to the complexity of hematopoietic cell transplant trial treatments, informed consent forms are often long and difficult to read. We evaluated a two-column easy-to-read informed consent (ETRIC) fo...
The informed consent process is central to the practice of surgery. Rather than a single event or required form, informed consent should be an educational discussion between the surgeon and patient co...
Informed consent is the heart of ethical research. For any consent to be ethically valid, it should meet certain critical criteria- disclosure and understanding of relevant information, decision makin...
DNA collection from family members of the missing is a tenet for missing persons' and mass fatality investigations. Procedures for consenting family members are disparate, depending on the context sup...
Informed consent given by someone other than the patient or research subject.
Informed consent given by a parent on behalf of a minor or otherwise incompetent child.
A disintegrin and metalloproteinase domain-containing protein that is expressed as two alternatively-spliced forms: a long transmembrane form (ADAM12-L) and a short soluble form (ADAM12-S). It modulates the cleavage of INSULIN-LIKE GROWTH FACTOR BINDING PROTEINS and may also regulate CELL FUSION during MYOGENESIS.
Equipment that sends digital information over telephone lines. The term Modem is a short form of the phrase modulator-demodulator.
Groups of persons whose range of options is severely limited, who are frequently subjected to COERCION in their DECISION MAKING, or who may be compromised in their ability to give INFORMED CONSENT.
Mergers & Acquisitions
Commercial and market reports on mergers and acquisitions in the biotechnology, pharmaceutical, medical device and life-science industries. Mergers and acquisitions (abbreviated M&A;) is an aspect of corporate strategy, corporate finance and manageme...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...