Multidisciplinary Support To Access Living Donor Kidney Transplant (MuST AKT)- A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Living Kidney Donor Evaluation Started
研究概览
简要总结
For patients with kidney failure the two treatment options are kidney transplantation or dialysis. Transplantation offers longer survival, better quality of life and provides cost savings for the health system (>$60,000/year per patient). Unfortunately, there are not enough organs available and 20% of patients die on dialysis waiting for a deceased donor kidney.
Living kidney donation is a safe and proven treatment that leads to even better patient and health system outcomes than deceased donor kidney transplant. The Kidney Health Strategic Clinical Network (KH-SCN) identified increasing living kidney donation as a priority and in 2015 established the Living Donor Kidney Transplant Working Group (LDKTWG) comprised of patients, donors, health care professionals, researchers, and administrators. In an evidenced review published by the investigators, the intervention with the best evidence and greatest impact was personalized support provided by a multidisciplinary team to inform and educate the patients' social network. This intervention increased living kidney donations by 34%. The investigators confirmed through a province wide survey that many patients with kidney failure are unable to find a living kidney donor and find it difficult to approach potential donors due to lack of skills, supports, and resources and these issues are particularly apparent in vulnerable populations. The investigators have developed the Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention to support patients in identifying and communicating with their social networks. The investigators will test the effectiveness of this intervention.
详细描述
Living donor kidney transplantation is the optimal treatment for end-stage kidney disease patients, dramatically improving survival and quality of life, providing significant cost saving compared with dialysis, reducing the demand for deceased donor transplants and the pressure to increase dialysis capacity and infrastructure. Outcome data shows that only 16% of Canadians on dialysis survive past 10 years, whereas up to 74% of Canadians with a kidney transplant have a functioning kidney after 10 years. The ideal treatment trajectory is to avoid dialysis entirely and receive a living donor transplant prior to dialysis (pre-emptive), which unfortunately only occurs in 10.5% of eligible patients.
Patients with end-stage kidney disease report being overwhelmed with other issues (loss of work, family stress, fear of dialysis) and lack the skills needed to comfortably engage potential living donors - many feel uncomfortable doing so and do not know how to start. The purpose of this research is to test an intervention designed to support patients identification of potential donors and communication with their social network and ultimately increase the number of living donor kidney transplantations.
Justification:
The rate of living kidney donor transplantation is lower in Alberta compared to other provinces in Canada. As the rate of kidney failure has increased over the past few years in Alberta, it is necessary to improve and facilitate the process of living kidney donor transplantation for better patient care.
Primary Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •No obvious contraindication to kidney transplantation
- •Completed 'introduction to kidney transplant' module
排除标准
- •Potential Living Kidney Donor identified
- •Previously received organ transplant
- •Candidate for multi-organ transplant
- •Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) Score > 20
- •Rapid Estimate of Adult Literacy in Medicine (REALM-66) score < 19 (illiterate in English)
研究组 & 干预措施
Intervention
This arm will receive the MuST AKT intervention, which is a multidisciplinary, tailored person-centered behavioural intervention designed to "help and enable" the potential kidney transplant recipients to achieve what is required to receive a living donor kidney transplantation.
干预措施: MuST AKT (Behavioral)
Usual Care (control)
In the usual care (control) condition, participants will go through the current standard of care, which is a social worker assessment.
结局指标
主要结局
Living Kidney Donor Evaluation Started
时间窗: 12 months
Proportion of participants with at least one potential donor who started evaluation
次要结局
- Living Kidney Donor Transplantation(24 months)
- Living Kidney Donor Evaluation Completed(12 months)
- Contact Living Donor Services(12 months)
- Identified potential advocates(From date of first to last documented session, an average of 3 months)