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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
50
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.
Hopital Necker - APHP
Paris, France
Hopital Saint Louis - APHP
Paris, France
Proportion of patients who have logged on to the Predigraft application at least 3 times
Time frame: at 12 months from study inclusion
French version of Functional, Communicative and Critical Health Literacy (FCCHL) scale
For each subscale of the FCCHL, the literacy score can range from 1 (low) to 5 (high). An overall score is calculated from the scores of the three subscales. A score ≤ 4 corresponds to a low level of literacy.
Time frame: at inclusion
French version of Functional, Communicative and Critical Health Literacy (FCCHL)
For each subscale of the FCCHL, the literacy score can range from 1 (low) to 5 (high). An overall score is calculated from the scores of the three subscales. A score ≤ 4 corresponds to a low level of literacy.
Time frame: at 12 months after inclusion
Connection time
Time frame: at 12 months after inclusion
Connection frequency
Time frame: at 12 months after inclusion
Time between two connections
Time frame: at 12 months after inclusion
Proportion of fonction used
Time frame: at 12 months after inclusion
Quality of life evaluating using SF36
Quality of life evaluated using MOS SF36 questionnaire (Medical Outcomes Study - 36-Item Short Form Health Survey). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 assesses different dimensions of feeling healthy and well being using 11 questions.These measures rely upon patient self-reporting.. In two dimensions, the answer is binary (yes / no) and in the other 6 in ordinal quality (3 to 6 possible answers). A high score means a better quality of life.
Time frame: at inclusion
Quality of life evaluating using SF36
Quality of life evaluated using MOS SF36 questionnaire (Medical Outcomes Study - 36-Item Short Form Health Survey). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 assesses different dimensions of feeling healthy and well being using 11 questions.These measures rely upon patient self-reporting.. In two dimensions, the answer is binary (yes / no) and in the other 6 in ordinal quality (3 to 6 possible answers). A high score means a better quality of life.
Time frame: at 6 weeks
Quality of life evaluated using SF36
Quality of life evaluated using MOS SF36 questionnaire (Medical Outcomes Study - 36-Item Short Form Health Survey). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 assesses different dimensions of feeling healthy and well being using 11 questions.These measures rely upon patient self-reporting.. In two dimensions, the answer is binary (yes / no) and in the other 6 in ordinal quality (3 to 6 possible answers). A high score means a better quality of life.
Time frame: at 12 months
Medication adherence
Medication adherence will be evaluation using the Basel Assessment of Adherence Scale Immunosuppression Scale (BAASIS scale). This is a self-assessment scale to evaluate medication adherence.
Time frame: at inclusion
Medication adherence
Medication adherence will be evaluation using the Basel Assessment of Adherence Scale Immunosuppression Scale (BAASIS scale). This is a self-assessment scale to evaluate medication adherence.
Time frame: at 6 weeks
Medication adherence
Medication adherence will be evaluation using the Basel Assessment of Adherence Scale Immunosuppression Scale (BAASIS scale). This is a self-assessment scale to evaluate medication adherence.
Time frame: at 12 months
Proportion of hospitalisations
Time frame: at 12 months after inclusion
Proportion of consultations
Time frame: at 12 months after inclusion
Proportion of emergency consultations or hospitalisations
Time frame: at 12 months after inclusion
Overall survival
Time frame: at 12 months after inclusion
Rejection and dialysis free survival
Time frame: at 12 months after inclusion
Cumulative incidence of graft rejection
Time frame: at 12 months after inclusion
Proportion of patients with deteriorated renal function
Renal function deterioration will be defined as an estimated glomerular filtration rate \< 30 ml/min/1.73m2 according to the MDRD equation and/or, a 10% decrease between inclusion and 12 months after inclusion.
Time frame: at 12 months after inclusion
Probability of graft survival
Time frame: at inclusion
Probability of graft survival
Time frame: up to 12 months
Probability of graft survival
Time frame: at 12 months
Time from date of graft to date of non-protocol DSA
Time frame: up to 12 months post-inclusion
Time from date of graft to date of non-protocol biopsy
Time frame: up to 12 months post-inclusion
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