Kidney Paired Donation: A Randomized Trial to Increase Knowledge and Informed Decision-Making
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 588
- 试验地点
- 6
- 主要终点
- Living Donation and KPD Knowledge
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of a targeted educational approach designed to increase knowledge about the risks and benefits of living donation generally and KPD (Kidney Paired Donation) specifically, enhance KPD self-efficacy, reduce KPD concerns, and facilitate informed decision-making about KPD among potential live kidney donor and kidney transplant patients.
详细描述
The investigators will conduct a randomized controlled trial (RCT) to examine the effectiveness of a video-based KPD education intervention to improve knowledge, self-efficacy, concerns, and informed decision-making about KPD among potential live kidney donor and kidney transplant patients.
There will be equal allocation of LKDs and intended recipients to both KPD education conditions: (1) Usual Care (UC) group and (2) UC plus video-based KPD education group. All enrolled LKDs and intended recipients will complete a baseline survey and another survey 2 weeks post-intervention. Additionally, follow-up data will be gathered on KPD decision-making, participation, and reasons for non-participation at 3 months post-intervention.
Settings and target population:
The study will be conducted at three kidney transplant programs in the United States: Beth Israel Deaconess Medical Center (BIDMC; Boston, MA), the Medical University of South Carolina (MUSC; Charleston, SC), and Erie County Medical Center (ECMC; Buffalo, NY). BIDMC will act as the coordinating center for this study and will be responsible for study design, oversite, reporting, updates, and final data analysis. MUSC and ECMC will rely on the CCI at BIDMC for review. This study will target potential LKDs and their intended recipients.
Randomization:
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
- Single (Investigator)
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
- •Speaks English or Spanish
- •Completed the initial living donation health screening
- •Transplant Candidates
- •Speaks English or Spanish
- •On that transplant waitlist (active or inactive)
排除标准
- •Non-directed (i.e., anonymous) potential LKDs
- •Previously undergone donor evaluation
- •Participation in another study to increase knowledge about living donation/LDK
- •Transplant Candidates
- •Had a prior LDKT
- •Previously enrolled in a KPD program
- •Previous or current participation in another study to increase knowledge about living donation/LDKT
- •Listed for a liver
结局指标
主要结局
Living Donation and KPD Knowledge
时间窗: three months post-intervention
A questionnaire will be used to assess living donation and KPD knowledge.
次要结局
- Living Donation and KPD Concerns(2 weeks post-intervention)
- Living Donation and KPD Self-Efficacy(2 weeks post-intervention)
- Living Donation and KPD Discussions(2 weeks post-intervention)
- Informed Decision-Making(2 weeks post-intervention)
研究者
James Rodrigue
Vice Chair of Clinical Research
Beth Israel Deaconess Medical Center