Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design
Background 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 evalu...
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| Veröffentlicht in: | BMC nephrology Jg. 18; H. 1; S. 126 - 9 |
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BioMed Central
05.04.2017
Springer Nature B.V BMC |
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| Abstract | Background
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.
Methods
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.
Discussion
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.
Trial registration
This study has been registered at ClinicalTrials.gov under
NCT02082093
(date of registration: February 14, 2014). |
|---|---|
| AbstractList | Background
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.
Methods
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.
Discussion
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.
Trial registration
This study has been registered at ClinicalTrials.gov under
NCT02082093
(date of registration: February 14, 2014). 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). BACKGROUND: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.METHODS: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.DISCUSSION: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.TRIAL REGISTRATION:This study has been registered at ClinicalTrials.gov under NCT02082093 (date of registration: February 14, 2014). Abstract Background 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. Methods 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. Discussion 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. Trial registration This study has been registered at ClinicalTrials.gov under NCT02082093 (date of registration: February 14, 2014). Background 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. Methods 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. Discussion 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. 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.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.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.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.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.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.This study has been registered at ClinicalTrials.gov under NCT02082093 (date of registration: February 14, 2014).TRIAL REGISTRATIONThis study has been registered at ClinicalTrials.gov under NCT02082093 (date of registration: February 14, 2014). |
| ArticleNumber | 126 |
| Author | Chanliau, Jacques Thilly, Nathalie Chauveau, Philippe Merville, Pierre Azar, Raymond Bataille, Pierre Noël, Christian Frimat, Luc Combe, Christian Laplaud, David Kessler, Michèle |
| Author_xml | – sequence: 1 givenname: Nathalie surname: Thilly fullname: Thilly, Nathalie email: n.thilly@chru-nancy.fr organization: CHRU de Nancy, Plateforme d’Aide à la Recherche Clinique, EA 4360 APEMAC, Université de Lorraine – sequence: 2 givenname: Jacques surname: Chanliau fullname: Chanliau, Jacques organization: Association Lorraine pour le Traitement de l’Insuffisance Rénale (ALTIR) – sequence: 3 givenname: Luc surname: Frimat fullname: Frimat, Luc organization: EA 4360 APEMAC, Université de Lorraine, CHRU de Nancy, Service de Néphrologie – sequence: 4 givenname: Christian surname: Combe fullname: Combe, Christian organization: CHU de Bordeaux, Service de Néphrologie Transplantation Dialyse, Université Bordeaux Segalen, Inserm U1026 – sequence: 5 givenname: Pierre surname: Merville fullname: Merville, Pierre organization: CHU de Bordeaux, Service de Néphrologie Transplantation Dialyse, Université Bordeaux Segalen, CNRS UMR5164 – sequence: 6 givenname: Philippe surname: Chauveau fullname: Chauveau, Philippe organization: CHU de Bordeaux, Service de Néphrologie Transplantation Dialyse, Université Bordeaux Segalen, Inserm U889 – sequence: 7 givenname: Pierre surname: Bataille fullname: Bataille, Pierre organization: CH de Boulogne sur Mer, Service de Néphrologie – sequence: 8 givenname: Raymond surname: Azar fullname: Azar, Raymond organization: CH de Dunkerque, Service de Néphrologie – sequence: 9 givenname: David surname: Laplaud fullname: Laplaud, David organization: Société Pharmagest – sequence: 10 givenname: Christian surname: Noël fullname: Noël, Christian organization: CHU de Lille, Service de Néphrologie – sequence: 11 givenname: Michèle surname: Kessler fullname: Kessler, Michèle organization: CHRU de Nancy, Service de Néphrologie |
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| CitedBy_id | crossref_primary_10_1177_20543581221106248 crossref_primary_10_1007_s11255_021_02816_8 crossref_primary_10_1093_ndt_gfab206 crossref_primary_10_1007_s40620_020_00812_2 crossref_primary_10_1186_s12882_018_1156_2 crossref_primary_10_1186_s12911_020_01375_9 crossref_primary_10_1053_j_ajkd_2021_09_010 crossref_primary_10_1136_bmjopen_2022_070927 crossref_primary_10_2196_humanfactors_9720 crossref_primary_10_1016_j_imu_2022_100930 crossref_primary_10_1016_j_nephro_2019_03_009 crossref_primary_10_1177_1357633X20959581 crossref_primary_10_2196_jmir_8914 crossref_primary_10_3889_oamjms_2023_7856 |
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| Keywords | Home telemonitoring Chronic kidney disease Dialysis Cost-effectiveness evaluation Telemedicine Kidney transplantation |
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Home telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare... Home telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare professionals and... Background Home telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare... BACKGROUND:Home telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare... Abstract Background Home telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare... |
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| SubjectTerms | Blood pressure Blood Pressure Determination Body Weight Chronic illnesses Chronic kidney disease Clinical Laboratory Services Clinical Research Communication Cost analysis Cost-Benefit Analysis Cost-effectiveness evaluation Delivery of Health Care - economics Delivery of Health Care - methods Dialysis Disease Management Electronic Health Records Expenditures France General Practice Health care access Hemoglobin Home telemonitoring Hospitals Human health and pathology Humans Information technology Internal Medicine Internet Kidney diseases Kidney Failure, Chronic - physiopathology Kidney Failure, Chronic - therapy Kidney Transplantation Kidney transplants Life Sciences Medical research Medicine Medicine & Public Health Mortality Nephrology Patients Peritoneal dialysis Physician-Patient Relations Population Quality of life Renal Dialysis Renal Insufficiency, Chronic - economics Renal Insufficiency, Chronic - physiopathology Renal Insufficiency, Chronic - therapy Severity of Illness Index Studies Study Protocol Symptom Assessment Telemedicine Telemedicine - economics Telemedicine - methods Transplantation Transplants & implants Urology and Nephrology |
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| 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 |
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