Evaluation of the Use of the Predigraft Platform (a Remote Monitoring Solution for Predicting Kidney Graft Survival) in Kidney Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proportion of patients who have logged on to the Predigraft application at least 3 times
研究概览
简要总结
Kidney transplantation is the treatment of choice for end-stage renal disease in terms of morbidity, mortality, and cost-benefit ratio. Graft loss is mainly related to the occurrence of rejection. Hence the importance of regular monitoring to check that the graft is functioning properly, to adapt immunosuppressive treatments and to check for side effects related to the immunosuppressed state.
In conventional management, the patient is seen at regular intervals (ranging from 2 weeks to 3 months) in the referral transplant centre with recourse to hospitalisation if necessary. In the context of the COVID-19 pandemic, in order to reduce the risks of contamination, teleconsultations have been proposed to replace face-to-face consultations. Predigraft software facilitates remote patient assessment. This software provides an estimate of the probability of renal graft survival at 3, 5 and 7 years of the assessment based on an algorithm developed and validated by the U970 unit (Loupy A et al, BMJ 2019). The software also provides an application for patients allowing secure data transfer (biological analyses, blood pressure, weight). This allows the assessment of the need for additional patient evaluation based on usual monitoring parameters (creatinine, proteinuria) that can be done in the analysis laboratory near the patient's home.
A first evaluation of the use and acceptability among care professionals has been conducted between April and June 2020 and showed excellent results. It is now necessary to obtain real-life data to evaluate the use of the tool among patients and healthcare professionals and its impact on the organisation of care.
This is a prospective interventional study with minimal risks and constraints on the active file of transplant patients followed in ambulatory care for a period of 12 months.
The objective of this study will be to evaluate the use of the Predigraft platform by kidney transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Patient who received a kidney transplant from a living or a deceased donor and transplanted at least 1 month ago
- •Patient over 18 years of age at the time of inclusion
- •Stable renal function (glomerular filtration rate>60 mL/min or decision at physician's discretion) at the time of inclusion
- •Informed patient with signed consent
- •Patient with access to an internet connection with a valid email
- •Enrolled in a social security scheme or beneficiary of such a scheme
排除标准
- •Combined transplant (e.g. kidney-heart transplant, kidney-liver transplant)
- •Kidney transplant less than 1 month old
- •Lack of recovery of kidney function following renal transplantation
- •Patient unable to use the telemedicine tool
- •Vulnerable participants (minors, protected adults, prisoners)
- •Patient under State Medical Assistance
研究组 & 干预措施
Predigraft
Patients in the interventional arm will use Predigraft (Class 1 medical device under MDD 93/42/EEC Cibiltech Society) to receive therapeutic education content (videos, facts sheets, short messages, questionnaires), exchange documents with their doctors and interact via messaging with them.
Physicians will be able to calculate their iBox score to predict their patients' allograft survival at 3, 5 and 7 years.
干预措施: Predigraft group (Device)
结局指标
主要结局
Proportion of patients who have logged on to the Predigraft application at least 3 times
时间窗: at 12 months from study inclusion
次要结局
- Connection time(at 12 months after inclusion)
- Quality of life evaluating using SF36(at 6 weeks)
- Quality of life evaluated using SF36(at 12 months)
- Proportion of emergency consultations or hospitalisations(at 12 months after inclusion)
- Probability of graft survival(at 12 months)
- Time between two connections(at 12 months after inclusion)
- Proportion of fonction used(at 12 months after inclusion)
- Cumulative incidence of graft rejection(at 12 months after inclusion)
- French version of Functional, Communicative and Critical Health Literacy (FCCHL) scale(at inclusion)
- French version of Functional, Communicative and Critical Health Literacy (FCCHL)(at 12 months after inclusion)
- Connection frequency(at 12 months after inclusion)
- Proportion of consultations(at 12 months after inclusion)
- Time from date of graft to date of non-protocol biopsy(up to 12 months post-inclusion)
- Medication adherence(at 12 months)
- Proportion of hospitalisations(at 12 months after inclusion)
- Overall survival(at 12 months after inclusion)
- Rejection and dialysis free survival(at 12 months after inclusion)
- Proportion of patients with deteriorated renal function(at 12 months after inclusion)
- Time from date of graft to date of non-protocol DSA(up to 12 months post-inclusion)
- Quality of life evaluating using SF36(at inclusion)
- Medication adherence(at inclusion)
- Medication adherence(at 6 weeks)
- Probability of graft survival(at inclusion)
- Probability of graft survival(up to 12 months)