Comparing Paper-based and Tablet-delivered Informed Consent for Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- University of California San Diego Brief Assessment of Capacity to Consent (UBACC)
研究概览
简要总结
The investigators will develop and test a tablet-delivered informed consent process. In a preliminary phase of the study, older adults will provide feedback on a prototype tablet-delivered consent by participating in a focus group. In a separate second phase, older adults will be randomly assigned to a tablet-delivered or paper-delivered consent condition in which their comprehension of material covered in the consent will be assessed.
详细描述
Clinical research is crucial for advancing healthcare, but patients must be able to make informed and voluntary choices about whether or not to participate in a research study. The informed consent process aspires to convey the purpose of research, the procedures involved, and the potential harms and benefits of taking part. Yet, the challenge of making informed consent easy to follow and understand is great: there are specific challenges for older research populations.
This study will develop and test a tablet-delivered informed consent process. The study will have two phases.
In the first phase, focus groups comprised of older adults will give their impressions of both a prototype tablet-delivered and paper consent, and the prototype will be refined according to feedback.
The second phase will evaluate whether older subjects judge a tablet-delivered consent to be more user-friendly than a paper-based version. It will also evaluate whether older subjects who participate in a tablet-delivered consent process have a better understanding of the research than those who participate in the paper-based version, and whether they remember the research details more fully after a one-week delay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 years and older
- •Cognitively intact
- •Ability to speak and read English
排除标准
- •Legal blindness
- •Severe hearing loss not corrected by assistive device
- •Inability to use hands to swipe a tablet's touch screen
- •No working telephone in the home
研究组 & 干预措施
Focus Group- paper and tablet consent
Participation in a focus group of other older adults, lasting 120 minutes. Participants will answer semi-structured questions in a group format, describing their impressions of both a prototype tablet-delivered and a paper consent.
干预措施: Focus Group- paper and tablet consent (Other)
Randomized- paper consent
Participants will review a mock paper consent form with a study clinician, and complete a series of questionnaires assessing their comprehension of material covered and general experience with the paper informed consent form.
干预措施: Randomized- paper consent (Other)
Randomized- Tablet-delivered consent
Participants will review a mock tablet-delivered consent form with a study clinician, and complete a series of questionnaires assessing their comprehension of material covered and general experience with the tablet-delivered informed consent.
干预措施: Randomized- Tablet-delivered consent (Other)
结局指标
主要结局
University of California San Diego Brief Assessment of Capacity to Consent (UBACC)
时间窗: immediately following intervention
次要结局
- study-specific measure of user-friendliness consent process(immediately following intervention)
- UBACC(One week following intervention)
研究者
Nimali Jayasinghe
Assistant Professor
Weill Medical College of Cornell University