GEnetic Counseling Through VIRTUAL Visits in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 2
- 主要终点
- Test-Related Distress
研究概览
简要总结
The research study is being conducted to compare methods of virtual genetic counseling for people with Parkinson's disease.
详细描述
This research will evaluate different virtual methods of pre-test genetic counseling and post-test genetic results disclosure in people with Parkinson's disease. Participants will be randomized to receive different methods of genetic counseling using web-based, telephone, or telehealth methods. In both pre- and post-test counseling phases, remote genetic counseling methods will be compared to demonstrate equivalence. The primary outcomes will be equivalence on genetics knowledge and outcomes scales, and the revised impact of events scale. The purpose is to develop effective and scalable approaches to genetic counseling. This work is crucial for patient safety and will improve access to care through novel genetic counseling approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to have clinical confirmation genetic testing, and comply with all study procedures and availability for the duration of the study
- •Male or female, over the age of
- •English Speaking
排除标准
- •Prior genetic counseling and/or clinical testing specifically for Parkinson's disease
- •Montreal Cognitive Assessment (MoCA) < 21, or a prior diagnosis of dementia during the screening phase
结局指标
主要结局
Test-Related Distress
时间窗: 3 months after disclosure counseling
Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)
Genetics Knowledge
时间窗: 4 weeks after pre-testing education/counseling
Genetics Knowledge Scale (20-question true/false questionnaire, score range 0-20, higher scores mean greater knowledge)
Genetic Counseling Satisfaction (Post-Test)
时间窗: Immediately after disclosure counseling
Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)
次要结局
- Depression(6 months after disclosure counseling)
- Genetic Counseling Satisfaction (Pre-Test)(Immediately after pre-test education/counseling)
- State-Trait Anxiety Index-State Score(3 months after disclosure counseling)
- State-Trait Anxiety Index -State Score(6 months after disclosure counseling)
- State-Trait Anxiety Index -Trait Score(6 months after disclosure counseling)
- Quality of Life in Parkinson's Disease(6 months after disclosure counseling)
- Test-Related Distress(6 months after disclosure counseling)
研究者
Thomas Tropea, DO
Assistant Professor
University of Pennsylvania