title: Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design.
abstract: 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. 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.
  
  
  
  eNephro 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.
  
  
  
  The 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.
  
  
  
  This study has been registered at ClinicalTrials.gov under NCT02082093 (date of registration: February 14, 2014).
authors.affiliation: CHRU de Nancy, Plateforme d'Aide à la Recherche Clinique, Nancy, France. n.thilly@chru-nancy.fr.|EA 4360 APEMAC, Université de Lorraine, 54511, Vandoeuvre-lès-Nancy Cedex, Nancy, France. n.thilly@chru-nancy.fr.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Thilly
authors.affiliation: Association Lorraine pour le Traitement de l'Insuffisance Rénale (ALTIR), Nancy, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Chanliau
authors.affiliation: EA 4360 APEMAC, Université de Lorraine, 54511, Vandoeuvre-lès-Nancy Cedex, Nancy, France.|CHRU de Nancy, Service de Néphrologie, Nancy, France.
authors.forename: Luc
authors.initials: L
authors.lastname: Frimat
authors.affiliation: CHU de Bordeaux, Service de Néphrologie Transplantation Dialyse, Bordeaux, France.|Université Bordeaux Segalen, Inserm U1026, Bordeaux, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Combe
authors.affiliation: CHU de Bordeaux, Service de Néphrologie Transplantation Dialyse, Bordeaux, France.|Université Bordeaux Segalen, CNRS UMR5164, Bordeaux, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Merville
authors.affiliation: CHU de Bordeaux, Service de Néphrologie Transplantation Dialyse, Bordeaux, France.|Université Bordeaux Segalen, Inserm U889, Bordeaux, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Chauveau
authors.affiliation: CH de Boulogne sur Mer, Service de Néphrologie, Boulogne sur Mer, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Bataille
authors.affiliation: CH de Dunkerque, Service de Néphrologie, Dunkerque, France.
authors.forename: Raymond
authors.initials: R
authors.lastname: Azar
authors.affiliation: Société Pharmagest, Nancy, France.
authors.forename: David
authors.initials: D
authors.lastname: Laplaud
authors.affiliation: CHU de Lille, Service de Néphrologie, Lille, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Noël
authors.affiliation: CHRU de Nancy, Service de Néphrologie, Nancy, France.
authors.forename: Michèle
authors.initials: M
authors.lastname: Kessler
mesh_terms: D001795:Blood Pressure Determination; D001835:Body Weight; D064790:Clinical Laboratory Services; D003142:Communication; D003362:Cost-Benefit Analysis; D003695:Delivery of Health Care / Q000191:economics / Q000379:methods*; D019468:Disease Management; D057286:Electronic Health Records; D005602:France; D058006:General Practice; D006801:Humans; D020407:Internet; D007676:Kidney Failure, Chronic / Q000503:physiopathology / Q000628:therapy; D016030:Kidney Transplantation; D009398:Nephrology; D010817:Physician-Patient Relations; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000191:economics / Q000503:physiopathology / Q000628:therapy*; D012720:Severity of Illness Index; D063189:Symptom Assessment; D017216:Telemedicine / Q000191:economics / Q000379:methods*
keywords: Chronic kidney disease; Cost-effectiveness evaluation; Dialysis; Home telemonitoring; Kidney transplantation; Telemedicine