Development and pilot evaluation of an audio-visual application to enhance the understanding of the informed consent process among research participants at a tertiary-referral cancer center.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
We aim to assess whether adding an audio-visual tool makes the informed consent process clearer and more effective for participants compared to using only a written document.
1.Develop and test an audio-visual tool that explains research studies in an engaging and accessible way.
2.Compare how well participants understand study details when using both the audio-visual tool and the written document versus the written document alone with the help of a questionnaire developed by the study team to evaluate the comprehensiveness of Informed consent form and Audio-Visual consent tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults (18+) who are potential research participants, who have the capacity to provide informed consent, and who are not impaired by any cognitive disabilities that would hinder comprehension.
排除标准
- •Individuals with auditory or visual impairments that make it difficult to use the audio-visual tool or read the written document.
- •Participants who have prior participation in clinical tria.
结局指标
主要结局
Primary Outcome
时间窗: 1-2 years
1) To develop and pilot test an audio-visual tool providing information about the research study for ongoing research studies with varying degree of complexity or risk to the participants.
时间窗: 1-2 years
2) To evaluate incremental benefit of audio-visual tool in combination with written Informed Consent Document on comprehension of the research participants.
时间窗: 1-2 years
次要结局
- Secondary Outcome-(1) To assess the additional time commitment of the research participants with the use of the audio-visual tool.)
研究者
Mrs Abhidnya V Desai
Tata Memorial Hospital Mumbai India