App-based Consent for Participation in Pediatric Clinical Research: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Effectiveness of app-based consent versus paper-based consent
研究概览
简要总结
This study aims to understand how well app-based consent performs compared to paper-based consent when recruiting families for a clinical research project. The investigators aim to demonstrate that app-based consent is as effective as traditional methods; this will be measured by questionnaires assessing the family's comprehension and preference.
详细描述
Purpose and justification:
Wider access to digital technologies, familiarity with apps, and the Coronavirus disease 2019 (COVID-19) pandemic increased the demand for virtual care, prompting the need for electronic documentation of consent for research as families no longer attend in-person clinics. The investigators previously developed an app to consent patients for donating research study data in addition to traditional paper-based consent. This study aims to understand how well app-based consent performs compared to paper-based consent when recruiting families for a clinical research project.
The investigators aim to demonstrate that app-based consent is as effective as traditional methods measured by questionnaires assessing the family's comprehension and preference. If successful, this study will provide evidence for using app-based consent to enable future researchers to use similar approaches or help us further improve our app. Supporting a diverse array of consenting methods that are equivalent in promoting comprehension and participant preferences can improve research recruitment rates and increase research participant satisfaction.
Hypotheses: App-augmented consent is not inferior to traditional paper-based consent in ensuring comprehension.
Research Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
As blinding is impossible, we will not conceal allocation from any members of the clinical or study teams.
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 2 to 5 years who need an IV insertion in the medical imaging department.
排除标准
- •Children who are nonverbal;
- •Children with existing vascular access
- •Families who choose not to have topical anesthetic placed on their child's hands
- •Children receiving anxiolytic premedication
- •Children planned to undergo mask induction of anesthesia before IV placement.
结局指标
主要结局
Effectiveness of app-based consent versus paper-based consent
时间窗: Immediately after consent is given for the study
To determine better or similar comprehension of study requirements, risks and benefits, as measured by a comprehension questionnaire, and better or similar family preference for this mode of consenting. Scored using a 5-item custom multiple-choice test, with higher scores being better.
次要结局
- Trust in the research consent process when using app-based consent versus paper-based consent(Immediately after consent is given for the study)
研究者
Matthias Görges, PhD
Associate Professor (Partner)
University of British Columbia