Informed Consent Formats by Information Preference and Priority
2018年1月24日 更新者：Carnegie Mellon University
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.
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
500
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- Carnegie Mellon University
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 18 Years Old or Older
- Read and agreed to informed consent
- Indicated desire to participate
- Diagnosed with asthma
- US resident
Exclusion Criteria:
- Participants from whom we receive multiple responses will be dropped from analysis (but will be compensated for participation)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Original
Participants will review the full-length, original consent form for the clinical trial.
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Participants will review the full-length, original consent form for the clinical trial.
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实验性的：Shortened
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.
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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.
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实验性的：Reordered
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).
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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).
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实验性的：Highlighted
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.
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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.
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实验性的：Interactive
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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Score for high impact questions
大体时间：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.
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through study completion, an average of 30 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Score for low impact questions
大体时间：through study completion, an average of 30 minutes
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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.
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through study completion, an average of 30 minutes
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Total score for all questions
大体时间：through study completion, an average of 30 minutes
|
Sum of correct answers (T/F) on full knowledge test.
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through study completion, an average of 30 minutes
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Interaction effect of format and importance on likelihood of correct answer
大体时间：through study completion, an average of 30 minutes
|
Interaction effect in a logistic regression predicting a correct answer, based on the format of the consent form and the importance of the answer.
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through study completion, an average of 30 minutes
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Scores for different information categories
大体时间：through study completion, an average of 30 minutes
|
Sum of correct answers (T/F) for each of the 20 information categories
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through study completion, an average of 30 minutes
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Effect of location on score
大体时间：through study completion, an average of 30 minutes
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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.
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through study completion, an average of 30 minutes
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Decision to enroll
大体时间：through study completion, an average of 30 minutes
|
Likert measure of participants hypothetical decision to enroll in the study
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through study completion, an average of 30 minutes
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Confidence in enrollment decision
大体时间：through study completion, an average of 30 minutes
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Likert measure of participants confidence in hypothetical decision to enroll in the study
|
through study completion, an average of 30 minutes
|
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Satisfaction with consent structure
大体时间：through study completion, an average of 30 minutes
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Likert measure of participants satisfaction with the consent form
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through study completion, an average of 30 minutes
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Perception of investigator concern for well being
大体时间：through study completion, an average of 30 minutes
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Likert measure of participants belief in the investigator's concerns for the participant's well-being
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through study completion, an average of 30 minutes
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Perception of investigator transparency
大体时间：through study completion, an average of 30 minutes
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Likert measure of participants belief that the investigator is trying to communicate information about the trial accurately
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through study completion, an average of 30 minutes
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Participant's probability estimate of the likelihood that the treatment would help control their asthma
大体时间：through study completion, an average of 30 minutes
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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%. |
through study completion, an average of 30 minutes
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Participant's free-response text describing what was learned from reading the informed consent document
大体时间：through study completion, an average of 30 minutes
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Survey question of the following form: "What are some of the key things you learned from reading the informed consent document?" Participants are then provided with an free-response text box where they are allowed to enter whatever text they want, as long as they enter some text. These responses will be coded by two independent coders, blinded to the treatment arms, using an emergent coding system to identify different topics that participants may raise. |
through study completion, an average of 30 minutes
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年11月27日
初级完成 (实际的)
2017年12月31日
研究完成 (实际的)
2017年12月31日
研究注册日期
首次提交
2018年1月8日
首先提交符合 QC 标准的
2018年1月24日
首次发布 (实际的)
2018年1月31日
研究记录更新
最后更新发布 (实际的)
2018年1月31日
上次提交的符合 QC 标准的更新
2018年1月24日
最后验证
2018年1月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- STUDY2017_00000268
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Original consent form的临床试验
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Jules Bordet InstituteRoche Pharma AG终止
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Bio-Strath AGZentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH完全的
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East Kent Hospitals University NHS Foundation Trust完全的
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Hannover Medical SchoolFresenius Kabi完全的