The smartNTx Trial: A Prospective, Randomized Controlled Trial (RCT) to Investigate Additional Interventional Telemedical Management Versus Standard Aftercare in Kidney Transplant Recipients (KTR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 391
- 试验地点
- 3
- 主要终点
- Unplanned hospitalizations
研究概览
简要总结
The smartNTx trial: Prospective, randomized controlled trial (RCT) to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients (KTR).
STUDY PURPOSE: To demonstrate that additional interventional telemedical management will lead to a higher chance for long-term graft survival, increase adherence, quality of life (QoL), and reduce complications and healthcare costs after kidney transplantation.
详细描述
This is a 1-year, prospective, randomized, 2-armed, parallel group multicenter trial in 3 German Kidney Transplant Centers (KTCs) to demonstrate that additional and continuous interventional telemedical management will lead to a better composite endpoint of 7 key outcome variables (hospitalizations, length of hospitalization, development of a de-novo donor specific antibody (DSA), medication adherence, tacrolimus intra-patient variability, blood pressure control and renal function after kidney transplantation). All patients will receive the same routine posttransplant aftercare. Patients in the interventional arm will receive a predefined additional telemedical management including regular telemedicine visits and automatic data transfer (e.g. vital signs, well-being, medication plan laboratory data and chat) between the patient at home and KTC through a certified smartphone application (comjoo business solutions GmbH, Berlin, Germany). Furthermore, home nephrologists of patients in the interventional arm are invited to participate in automatic data transfer of key variables (such as vital signs, laboratory data) with KTC. A separate telemedicine team will constantly review the incoming data according to a predefined protocol and eventually contact the patient and/or the home nephrologist in order to start appropriate interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplantation within last 12 months
- •Treatment with tacrolimus
- •Routine aftercare planned at KTC
- •Ability to use a smartphone or tablet or with help of someone close by
- •For children < 12 years parents have to take over the use of the smartphone
- •Patients who are willing and able to participate in the study and from whom written informed consent has been obtained prior to study participation or pediatric patients with parenteral consent
- •Ability to communicate in German or English
- •Adequate and stable renal function (eGFR > 30 ml/min, Proteinuria < 1g/g creatinine) eGFR will be determined according to CKD-EPI for adults [81] or Schwartz formula for children [82]
排除标准
- •Patient with mental dysfunction or inability to comply with the study protocol or pediatric patients whose parents cannot comply with the study protocol
- •Any significant diseases or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination findings that would in the opinion of the investigator preclude the patient from participating in the study
- •History of alcohol or drug abuse with less than 6 months of sobriety
- •Participation in any other interventional clinical trial less than 1 month before participation in this study
- •Patients who have been institutionalized by official or court order
- •Patients with a combined kidney transplant or multi-organ recipients (other solid organ (e.g. pancreas) or bone marrow)
- •Presence of DSA with MFI > 1000 at time of transplantation
- •Recurrence of underlying kidney disease (e.g. focal segmental glomerulosclerosis (FSGS) or atypical hemolytic uremic syndrome (aHUS)
- •Patient with active malignancy post-transplant with the exception of local, non-invasive, fully excised, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ
- •Patients with clinically symptomatic congestive heart failure (CHF) or symptomatic coronary artery disease
- •Patients with documented (either by serology and/or nuclear acid testing (NAT) clinically active infections (e.g. with a known hepatitis B (HBV), hepatitis C (HCV), HIV, CMV or BK virus infection).
研究组 & 干预措施
Intervention group "Additional telemedical management"
Patients in the interventional arm will receive a predefined additional telemedical management including regular telemedicine visits and automatic data transfer (e.g. vital signs, well-being, medication plan laboratory data and chat) between the patient at home and KTC through a certified smartphone application.
干预措施: Additional interventional telemedical management (Combination Product)
Control group "Routine posttransplant aftercare"
Patients in the control group will receive routine posttransplant aftercare.
结局指标
主要结局
Unplanned hospitalizations
时间窗: 12 months
yes/no during study period
Medication adherence
时间窗: 12 months
According to BAASIS questionnaire at month 12
Length of unplanned hospitalization
时间窗: 12 months
More/less than 10 nights during study period
Development of de-novo DSA
时间窗: 12 months
yes/no at month 12
Tacrolimus intra-patient variability
时间窗: 12 months
Above/below 30% between month 6 to 12
Blood pressure control
时间窗: 12 months
normal/abnormal 24h-RR profile at month 12
Renal function
时间窗: 12 months
suboptimal renal function (eGFR \< 45 ml/min at month 12
次要结局
- Reduced graft losses (result evalution)(12 months)
- Better prognosis of the iBox score (result evalution)(12 months)
- Improvement in quality of life (result evalution)(12 months)
- Improving disease management (process evalution)(12 months)
- Acceptance of the new restoration among patients (process evalution)(12 months)
- Acceptance of the new restoration among service providers (process evalution)(12 months)