Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Participants' understanding of the ViDES study as assessed by a questionnaire
研究概览
简要总结
This pilot randomized controlled trial evaluates the impact of video-enhanced consent compared to the usual approach. The investigators aim to assess if video-enhanced consent empowers decision-making and improves understanding in parents considering participation in the ViDES study, which investigates the effectiveness of Vitamin D supplementation in extremely preterm infants (the ViDES study is separately registered as NCT05459298).
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents/legal guardians of extremely preterm infants (<28 weeks gestational age or <1000 g birth weight) admitted to the Neonatal Intensive Care Unit at Children's Memorial Hermann hospital that qualify for the ViDES study (ViDES study is separately registered as NCT05459298)
排除标准
- •Parents/legal guardians deaf or blind
- •Parents/legal guardians unable to consent for the VIDES study
结局指标
主要结局
Participants' understanding of the ViDES study as assessed by a questionnaire
时间窗: Within 48 hours of the intervention
The questionnaire assesses recall of possible benefits and risks of participation.
Participants' satisfaction with consent approach as assessed by a questionnaire
时间窗: Within 48 hours of the intervention
The questionnaire assesses satisfaction with ability to ask questions and decision time.
ViDES trial consent rate
时间窗: Within 1 week of the intervention
Participant's opinions related to participation in research as assessed by a questionnaire
时间窗: Within 48 hours of the intervention
The questionnaire assesses participant's opinions related to participation in research and research being part of the care of infants.
次要结局
未报告次要终点
研究者
Maria del Mar Romero López
Assistant Professor
The University of Texas Health Science Center, Houston