A Randomized Study of Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 613
- 主要终点
- Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale
研究概览
简要总结
The purpose of this study is to compare two methods for remote genetic counseling (telephone and two-way videoconferencing) for patients who are receiving disclosure of their APOE (apolipoprotein E) genotype. The target population will consist of males and females in the age range of 60-75 years who, as potential participants in a study (Generation Study), will need to receive genetic counseling and disclosure of APOE genotype. Subjects must be willing to receive genetic counseling and disclosure remotely. Subjects must be willing to be randomized to either telephone arm or videoconference arm.
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible to participate in the Generation Study
- •Ability to provide consent
- •Ability to communicate and hear in English
排除标准
- 未提供
研究组 & 干预措施
Telephone
Telephone telegenetics counseling: A trained Penn genetic counselor will conduct genotype disclosure visits with the participant via telephone. The participant will be in a private room at the study site. Telephone sessions will utilize a private phone line. The genetic counselor will use standardized disclosure checklist and visual aids for the disclosure session.
干预措施: Telephone remote genetic counseling (Other)
Videoconference
Two-way videoconferencing telegenetics counseling: A trained Penn genetic counselor will conduct genotype disclosure visits with the participant via two-way videoconferencing. The participant will be in a private room at the study site. Videoconferencing sessions will utilize tablets or laptops with web cameras and secure/confidential software for teleconferencing. The genetic counselor will use standardized disclosure checklist and visual aids for the disclosure session.
干预措施: Two-way videoconference remote genetic counseling (Other)
结局指标
主要结局
Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale
时间窗: 2-7 days
Satisfaction with genetic counseling services as measured by the Satisfaction with Remote Counseling Scale
时间窗: 2-7 days
次要结局
- Disease-specific distress as measured by the Impact of Events Scale(2-7 days, 6 weeks, 6 months, 12 months)
- Knowledge of Genetic Disease as measured by the Cancer Genetics Knowledge Scale(2-7 days, 6 weeks, 6 months, 12 months)
- Responses to Genetic Testing as measured by the Impact of Genetic Testing for Alzheimer's disease (IGT-AD) scale(2-7 days, 6 weeks, 6 months, 12 months)
- Perceived risk of Alzheimers Disease as measured by questionnaire items measuring perceived risk in quantitative, qualitative, and relative terms(2-7 days, 6 weeks, 6 months, 12 months)
- Depression as measured by the GDS Short Form(2-7 days, 6 weeks, 6 months, 12 months)
- Anxiety as measured by the Mini State Trait Anxiety Inventory (mSTAI):(2-7 days, 6 weeks, 6 months, 12 months)
- Knowledge of Genetic Disease as measured by the ClinSeq Knowledge Scale(2-7 days, 6 weeks, 6 months, 12 months)