Abstract
BackgroundHome telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare professionals and patients and to promote early detection of deteriorating health status. In the nephrology setting, home telemonitoring has been evaluated in home dialysis patients but data are scarce concerning chronic kidney disease (CKD) patients before and after renal replacement therapy. The eNephro study is designed to assess the cost effectiveness, clinical/biological impact, and patient perception of a home telemonitoring for CKD patients. Our purpose is to present the rationale, design and organisational aspects of this study.MethodseNephro is a pragmatic randomised controlled trial, comparing home telemonitoring versus usual care in three populations of CKD patients: stage 3B/4 (n = 320); stage 5D CKD on dialysis (n = 260); stage 5 T CKD treated with transplantation (n= 260). Five hospitals and three not-for-profit providers managing self-care dialysis situated in three administrative regions in France are participating. The trial began in December 2015, with a scheduled 12-month inclusion period and 12 months follow-up. Outcomes include clinical and biological data (e.g. blood pressure, haemoglobin) collected from patient records, perceived health status (e.g. health related quality of life) collected from self-administered questionnaires, and health expenditure data retrieved from the French health insurance database (SNIIRAM) using a probabilistic matching procedure.DiscussionThe hypothesis is that home telemonitoring enables better control of clinical and biological parameters as well as improved perceived health status. This better control should limit emergency consultations and hospitalisations leading to decreased healthcare expenditure, compensating for the financial investment due to the telemedicine system.Trial registrationThis study has been registered at ClinicalTrials.gov under NCT02082093 (date of registration: February 14, 2014).
Highlights
Home telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare professionals and patients and to promote early detection of deteriorating health status
There have been very few assessments of the medicoeconomic interest of home telemonitoring for chronic diseases, and the quality of evidence has often been weakened by methodological flaws
It is difficult to compare home telemonitoring with usual care for the chronic diseases studied [25]. eNephro is the first medicoeconomic study designed to evaluate the benefits of home telemonitoring for chronic kidney disease (CKD) patients at different stages
Summary
There have been very few assessments of the medicoeconomic interest of home telemonitoring for chronic diseases, and the quality of evidence has often been weakened by methodological flaws. It is expected that the expert systems identifies early situations where patients risk for decompensation and/or deterioration of their health status, even before the development of clinical symptoms prompt them to seek medical assistance This should enable more rapid medical intervention and a lower rate of hospitalisation. Home telemonitoring contributes to cost containment by limiting the need for patient transportation, by reducing the number of incentre visits, hospitalisations and by favouring early care for deteriorated health status and by preventing complications. In the eNephro study, it is expected that the costs generated by the telemedicine system are counterbalanced by lower overall healthcare costs In this case, the results would be an important argument favouring reimbursement of home telemonitoring costs by the national health insurance fund.
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