NCT04242667已完成不适用
A Randomized Protocol Evaluating Return of Actionable Genetic Research Results to Biobank Participants
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Completion of surveys
研究概览
简要总结
The overall goal of the proposed research is to assess the feasibility of a randomized study evaluating the non-inferiority of an electronic Health (e-Health) delivery alternative (e.g. private web portal) as compared to return of actionable genetic research results with a genetic counselor.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consented participant in University of Pennsylvania Biobank who previously submitted a DNA sample for research testing
- •English speaking
- •Aged 18 years or older
- •Agreed to be re-contacted in the future or did not indicate a preference on future contact regarding research results
- •Have an actionable mutation or have been selected as a control participant
- •Have not previously received actionable results of clinical genetic testing
排除标准
- •Deceased assessed by electronic medical record, death index or identified after contact
- •Evidence in the electronic medical record that the subject has already received the same actionable result through clinical genetic testing
研究组 & 干预措施
Actionable gene result for cancer risk
Experimental
干预措施: e-Health (web-based) disclosure portal (Behavioral)
Actionable gene result for cancer risk
Experimental
干预措施: Provider mediated disclosure (Behavioral)
Actionable gene result for cardiovascular disease risk
Experimental
干预措施: e-Health (web-based) disclosure portal (Behavioral)
Actionable gene result for cardiovascular disease risk
Experimental
干预措施: Provider mediated disclosure (Behavioral)
结局指标
主要结局
Completion of surveys
时间窗: Baseline survey prior to disclosure of results, and then two post-disclosure surveys at 2-7 days and 6 months
Participant will self-complete surveys to collect psychological and knowledge outcomes
次要结局
未报告次要终点
研究者
研究点 (1)
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