Interactive Tool for Informed Consent: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- level of consent comprehension
研究概览
简要总结
Online trials require informed consent from participants. Massive online trials make face-to-face signed consent unrealistic and existing consent comprehension could be improved to increase participant safety and understanding.
This trial will compare understanding of traditional digital consent with multi-media consent and with consent that is multi-media and interactive and uses a test and train model.
The computer will assign participants to 1 of 3 methods to present online consent to participants
详细描述
Online trials require informed consent from participants. Massive online trials make face-to-face signed consent unrealistic and existing consent comprehension could be improved to increase participant safety.
Without accurate knowledge decision-making is not informed. Informed consent for participation in research is part of this process. In online trials the opportunity for face-to-face signed consent with researchers is not an option.
Consent acts as a safeguard that full disclosure occurred. Adequate documentation is evidence against false reports of coercion.
Informed consent inclusive of signed participant information sheets provide a record between researcher and participant of the roles and agreements they share.
According to existing research, only 6% of consents and participant information sheets are written below an eighth grade level of comprehension; 54% of participants with an 8th grade level education partially understood the consent with figures rising to 72% for participants with greater than 8th grade educations, however no participant fully understood the consent materials. The deficits ranged from misunderstandings about risk, side effects, adverse effects reporting, a participants right to withdraw, confidentiality and even the purpose of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •pre-screened as eligible for a ThinkWell PLOT trial
- •18 years of age
- •No personal email address
排除标准
- •not pre-screened or eligible for an existing ThinkWell PLOT trial
- •people without internet access
- •People who cannot read
- •People without the ability to understand the website and informed consent documents
研究组 & 干预措施
Digital informed consent
Traditional digitally signed text based informed consent
Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate
干预措施: Intervention A: Questionnaire accuracy (Behavioral)
Digital informed consent
Traditional digitally signed text based informed consent
Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate
干预措施: Intervention B: Questionnaire speed of completion (Behavioral)
Digital informed consent
Traditional digitally signed text based informed consent
Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate
干预措施: Intervention C: Questionnaire Completion rate (Behavioral)
Multi-media informed consent
Informed consent with images, text and auditory presentation
Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate
干预措施: Intervention A: Questionnaire accuracy (Behavioral)
Multi-media informed consent
Informed consent with images, text and auditory presentation
Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate
干预措施: Intervention B: Questionnaire speed of completion (Behavioral)
Multi-media informed consent
Informed consent with images, text and auditory presentation
Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate
干预措施: Intervention C: Questionnaire Completion rate (Behavioral)
Test to train informed consent
Informed consent with images, text, auditory presentation and test to train feature where participants get feedback on comprehension responses throughout the consent and can change them
Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate
干预措施: Intervention A: Questionnaire accuracy (Behavioral)
Test to train informed consent
Informed consent with images, text, auditory presentation and test to train feature where participants get feedback on comprehension responses throughout the consent and can change them
Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate
干预措施: Intervention B: Questionnaire speed of completion (Behavioral)
Test to train informed consent
Informed consent with images, text, auditory presentation and test to train feature where participants get feedback on comprehension responses throughout the consent and can change them
Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate
干预措施: Intervention C: Questionnaire Completion rate (Behavioral)
结局指标
主要结局
level of consent comprehension
时间窗: immediately following intervention
assessed by accuracy on scored questionnaire
次要结局
- Compliance(immediately following intervention)
- Time to complete consent(immediately following intervention)