Telemedicine for Evaluation and Counseling of Living Kidney Donor Candidates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
The goal of this feasibility clinical trial is to learn if telemedicine can be used to provide education and evaluation and counseling for people who are considering living kidney donation. The study will also learn how participants improve decision-making about living kidney donation. The main questions to answer are:
- Is telemedicine a practical way to facilitate donor education and evaluation and counseling?
- Does telemedicine shared decision making help improve donor candidate decision and engagement during the donor evaluation process?
Researchers will compare standard care with a telemedicine care coordination approach.
Participants will:
- Receive either standard care or telemedicine video visits to support shared decision making.
详细描述
Living kidney donation provides a vital treatment option for patients with kidney failure, but many willing individuals face challenges in completing the donor evaluation and committing to donation. Donor education and counseling are essential for informed decision-making, yet these steps are often limited to in-person visits at transplant centers. This can create logistical challenges, delays, and variations in access to the living donor evaluation process. Telemedicine offers an opportunity to deliver a shared decision making approach to donor education and evaluation and counseling remotely, but its feasibility, acceptability, and impact have not been well studied.
This pilot feasibility clinical trial is designed to test whether a telemedicine care coordination can support donor decision-making and engagement during the evaluation process for living kidney donation.
Participants will be randomly assigned to one of two groups:
- Standard Care Group (Control): A recorded video education session and an in-person donor evaluation and counseling with a nephrologist.
- Telemedicine Group (Intervention): Two live telemedicine video sessions-one for education with a transplant provider and one for donor evaluation and counseling with a nephrologist.
The findings from this feasibility trial will provide important information about the practicality and acceptability of telemedicine shared decision-making for living kidney donor candidates. Generated preliminary data will inform larger trials and ultimately guide transplant practice and policy to improve decision-making, efficiency, and access to living kidney donation.
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
- 是
入选标准
- •18 years of age or older
- •Reside in the State of California
- •Registered living kidney donor candidate at UC Irvine Medical Center
排除标准
- •- Individuals with a contraindication to living kidney donation (for example, heart disease, cancer)
研究组 & 干预措施
Standard Care Group (Control)
Participants in the standard care group will receive a recorded video education session and one in-person donor evaluation and counseling session with a nephrologist.
干预措施: Standard Care (in control arm) (Behavioral)
Telemedicine Group (Intervention)
Participants in the telemedicine group will receive two live telemedicine video sessions: one education session with a transplant provider and one donor evaluation and counseling session with a nephrologist.
干预措施: Telemedicine Shared Decision-Making (Behavioral)
结局指标
主要结局
Recruitment Rate
时间窗: 90 days
Proportion of eligible participants who consent and enroll in the study, calculated as the number enrolled divided by the number of eligible participants approached.
Retention Rate
时间窗: 90 days
Proportion of enrolled participants who remain in the study through the 90-day follow-up period, calculated as the number completing final follow-up divided by the number enrolled.
Change in Decisional Conflict Measured by the Decisional Conflict Scale (DCS)
时间窗: 90 days
Decision conflict will be measured using the Decisional Conflict Scale (DCS), a 16-item validated instrument. Each item is scored from 0 (no conflict) to 100 (very high conflict), and a total score is calculated by averaging across items. Total scores therefore range from 0 to 100, with higher scores indicating worse decision conflict and greater uncertainty.
次要结局
- Completion of Donor Education and Evaluation and Counseling(90 days)
- Intervention Acceptability(Post-telemedicine session 1 at 7 days, and telemedicine session 2 at 67 days)
研究者
Fawaz Al Ammary
Associate Professor of Medicine, Director of Mixed Methods Research.
University of California, Irvine