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
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)