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Titulo Artículo:
TELEmedicine for EPIlepsy Care (TELE- EPIC): protocol of a randomised, open controlled non-inferiority clinical trial
Resumen:
Introduction Epilepsy is a chronic condition requiring consistent follow-up aimed at seizure control, and monitoring of anti-seizure medication (ASM) levels and side effects. Telemedicine (TM) offers invaluable support to patient follow-up, guaranteeing the prompt availability of a team of experts for persons with epilepsy (PWE) widely distributed across the country. Although many health institutions have endorsed the use of TM, robust data on effectiveness, safety and costs of TM applied to epilepsy are lacking. TELEmedicine for EPIlepsy Care (TELE-EPIC) will evaluate the effectiveness of video consultation (VC) via TM compared with usual care (UC) for the monitoring of PWE (TELE-EPIC_RCT). Moreover, TELE-EPIC will apply an innovative Volumetric Absorptive Microsampling (VAMS) device for quantitation of ASM through finger prick blood sampling as an alternative to venipuncture sampling (TELE-EPIC_VAMS). Methods and analysis TELE-EPIC_RCT is a multicentre, open, pragmatic two-arm randomised controlled trial prospectively including adult and paediatric outpatients with established diagnosis of epilepsy consecutively attending the Epilepsy Centres of Bologna and Rome, respectively. The primary outcome is the non-inferiority of VC on seizure control compared with UC after an 18-month follow-up. Secondary outcomes are adherence to treatment, ASM-related adverse events, quality of life, mood disorders, patient and caregiver satisfaction, safety and costs. TELE-EPIC_VAMS is a cross-validation study for blood ASM quantitation through a novel, VAMS-based device, comparing (1) VAMS versus plasma samples (reference standard method); and (2) nurse-collected versus self-collected blood by VAMS device. Ethics and dissemination The study has been approved by the local ethics committee (349-2019-SPER-AUSLBO). Complete information about the state of project, relevant events and results will be regularly updated on the project’s webpage on ClinicalTrials.gov. The project’s results and data on the potential impact of TM in epilepsy will be disseminated on social media. A closeout meeting will be convened for the communication and dissemination of the project, highlighting its main achievements and impacts.
Fecha de publicación:
2021.
Autores :
Marina Trivisano;
Francesca Bisulli;
Paolo Tinuper;
Luca Vignatelli;
Barbara Mostacci;
Elisa Baldin ;
Susan Mohamed;
Corrado Zenesini;
Manuela Contin;
Laura Licchetta;
Autor corporativo:
BMJ Open,
Editores:
Medline-PubMed ;
Signatura Topográfica:
12
Idioma:
Inglés
Páginas:
1
ISBN:
2044-6055
Existencias:
8
Palabras claves:
Telemedicine
EPIlepsy Care
Clinical trial
Público objetivo:
Docentes
Investigadores
Clinicos
Educadores Medicos
Titulo Artículo:
TELEmedicine for EPIlepsy Care (TELE- EPIC): protocol of a randomised, open controlled non-inferiority clinical trial
Resumen:
Introduction Epilepsy is a chronic condition requiring consistent follow-up aimed at seizure control, and monitoring of anti-seizure medication (ASM) levels and side effects. Telemedicine (TM) offers invaluable support to patient follow-up, guaranteeing the prompt availability of a team of experts for persons with epilepsy (PWE) widely distributed across the country. Although many health institutions have endorsed the use of TM, robust data on effectiveness, safety and costs of TM applied to epilepsy are lacking. TELEmedicine for EPIlepsy Care (TELE-EPIC) will evaluate the effectiveness of video consultation (VC) via TM compared with usual care (UC) for the monitoring of PWE (TELE-EPIC_RCT). Moreover, TELE-EPIC will apply an innovative Volumetric Absorptive Microsampling (VAMS) device for quantitation of ASM through finger prick blood sampling as an alternative to venipuncture sampling (TELE-EPIC_VAMS). Methods and analysis TELE-EPIC_RCT is a multicentre, open, pragmatic two-arm randomised controlled trial prospectively including adult and paediatric outpatients with established diagnosis of epilepsy consecutively attending the Epilepsy Centres of Bologna and Rome, respectively. The primary outcome is the non-inferiority of VC on seizure control compared with UC after an 18-month follow-up. Secondary outcomes are adherence to treatment, ASM-related adverse events, quality of life, mood disorders, patient and caregiver satisfaction, safety and costs. TELE-EPIC_VAMS is a cross-validation study for blood ASM quantitation through a novel, VAMS-based device, comparing (1) VAMS versus plasma samples (reference standard method); and (2) nurse-collected versus self-collected blood by VAMS device. Ethics and dissemination The study has been approved by the local ethics committee (349-2019-SPER-AUSLBO). Complete information about the state of project, relevant events and results will be regularly updated on the project’s webpage on ClinicalTrials.gov. The project’s results and data on the potential impact of TM in epilepsy will be disseminated on social media. A closeout meeting will be convened for the communication and dissemination of the project, highlighting its main achievements and impacts.
Fecha de publicación:
2021.
Autores :
Marina Trivisano;
Francesca Bisulli;
Paolo Tinuper;
Luca Vignatelli;
Barbara Mostacci;
Elisa Baldin ;
Susan Mohamed;
Corrado Zenesini;
Manuela Contin;
Laura Licchetta;
Autor corporativo:
BMJ Open,
Editores:
Medline-PubMed ;
Signatura Topográfica:
12
Idioma:
Inglés
Páginas:
1
Existencias:
8
Palabras claves:
Telemedicine
EPIlepsy Care
Clinical trial
Público objetivo:
Docentes
Investigadores
Clinicos
Educadores Medicos
Titulo Artículo:
TELEmedicine for EPIlepsy Care (TELE- EPIC): protocol of a randomised, open controlled non-inferiority clinical trial
Resumen:
Introduction Epilepsy is a chronic condition requiring consistent follow-up aimed at seizure control, and monitoring of anti-seizure medication (ASM) levels and side effects. Telemedicine (TM) offers invaluable support to patient follow-up, guaranteeing the prompt availability of a team of experts for persons with epilepsy (PWE) widely distributed across the country. Although many health institutions have endorsed the use of TM, robust data on effectiveness, safety and costs of TM applied to epilepsy are lacking. TELEmedicine for EPIlepsy Care (TELE-EPIC) will evaluate the effectiveness of video consultation (VC) via TM compared with usual care (UC) for the monitoring of PWE (TELE-EPIC_RCT). Moreover, TELE-EPIC will apply an innovative Volumetric Absorptive Microsampling (VAMS) device for quantitation of ASM through finger prick blood sampling as an alternative to venipuncture sampling (TELE-EPIC_VAMS). Methods and analysis TELE-EPIC_RCT is a multicentre, open, pragmatic two-arm randomised controlled trial prospectively including adult and paediatric outpatients with established diagnosis of epilepsy consecutively attending the Epilepsy Centres of Bologna and Rome, respectively. The primary outcome is the non-inferiority of VC on seizure control compared with UC after an 18-month follow-up. Secondary outcomes are adherence to treatment, ASM-related adverse events, quality of life, mood disorders, patient and caregiver satisfaction, safety and costs. TELE-EPIC_VAMS is a cross-validation study for blood ASM quantitation through a novel, VAMS-based device, comparing (1) VAMS versus plasma samples (reference standard method); and (2) nurse-collected versus self-collected blood by VAMS device. Ethics and dissemination The study has been approved by the local ethics committee (349-2019-SPER-AUSLBO). Complete information about the state of project, relevant events and results will be regularly updated on the project’s webpage on ClinicalTrials.gov. The project’s results and data on the potential impact of TM in epilepsy will be disseminated on social media. A closeout meeting will be convened for the communication and dissemination of the project, highlighting its main achievements and impacts.
Autores:
Marina Trivisano
,
Francesca Bisulli
,
Paolo Tinuper
,
Luca Vignatelli
,
Barbara Mostacci
,
Elisa Baldin
,
Susan Mohamed
,
Corrado Zenesini
,
Manuela Contin
,
Laura Licchetta
,
.
Titulo Revista:
BMJ Open,
.
Numero:
12
Volumen:
11
Fecha de publicación:
2021.
Base de Datos Bibliográfica:
Medline-PubMed ,
.
Suplemento:
Idioma:
Inglés
Página Inicial:
1
Página Final:
8
ISBN:
2044-6055
Palabras claves:
Telemedicine
EPIlepsy Care
Clinical trial
Público objetivo:
Docentes
Investigadores
Clinicos
Educadores Medicos
Título Medline-PubMed :
TELEmedicine for EPIlepsy Care (TELE- EPIC): protocol of a randomised, open controlled non-inferiority clinical trial
Resumen:
Introduction Epilepsy is a chronic condition requiring consistent follow-up aimed at seizure control, and monitoring of anti-seizure medication (ASM) levels and side effects. Telemedicine (TM) offers invaluable support to patient follow-up, guaranteeing the prompt availability of a team of experts for persons with epilepsy (PWE) widely distributed across the country. Although many health institutions have endorsed the use of TM, robust data on effectiveness, safety and costs of TM applied to epilepsy are lacking. TELEmedicine for EPIlepsy Care (TELE-EPIC) will evaluate the effectiveness of video consultation (VC) via TM compared with usual care (UC) for the monitoring of PWE (TELE-EPIC_RCT). Moreover, TELE-EPIC will apply an innovative Volumetric Absorptive Microsampling (VAMS) device for quantitation of ASM through finger prick blood sampling as an alternative to venipuncture sampling (TELE-EPIC_VAMS). Methods and analysis TELE-EPIC_RCT is a multicentre, open, pragmatic two-arm randomised controlled trial prospectively including adult and paediatric outpatients with established diagnosis of epilepsy consecutively attending the Epilepsy Centres of Bologna and Rome, respectively. The primary outcome is the non-inferiority of VC on seizure control compared with UC after an 18-month follow-up. Secondary outcomes are adherence to treatment, ASM-related adverse events, quality of life, mood disorders, patient and caregiver satisfaction, safety and costs. TELE-EPIC_VAMS is a cross-validation study for blood ASM quantitation through a novel, VAMS-based device, comparing (1) VAMS versus plasma samples (reference standard method); and (2) nurse-collected versus self-collected blood by VAMS device. Ethics and dissemination The study has been approved by the local ethics committee (349-2019-SPER-AUSLBO). Complete information about the state of project, relevant events and results will be regularly updated on the project’s webpage on ClinicalTrials.gov. The project’s results and data on the potential impact of TM in epilepsy will be disseminated on social media. A closeout meeting will be convened for the communication and dissemination of the project, highlighting its main achievements and impacts.
Autores :
Marina Trivisano;
Francesca Bisulli;
Paolo Tinuper;
Luca Vignatelli;
Barbara Mostacci;
Elisa Baldin ;
Susan Mohamed;
Corrado Zenesini;
Manuela Contin;
Laura Licchetta;
Autor corporativo:
BMJ Open,
Fecha de publicación:
2021.
Tipo :
Medline-PubMed .
Idioma:
Inglés
Palabras claves:
Telemedicine
EPIlepsy Care
Clinical trial
Público objetivo:
Docentes
Investigadores
Clinicos
Educadores Medicos
Título Medline-PubMed :
TELEmedicine for EPIlepsy Care (TELE- EPIC): protocol of a randomised, open controlled non-inferiority clinical trial
Resumen:
Introduction Epilepsy is a chronic condition requiring consistent follow-up aimed at seizure control, and monitoring of anti-seizure medication (ASM) levels and side effects. Telemedicine (TM) offers invaluable support to patient follow-up, guaranteeing the prompt availability of a team of experts for persons with epilepsy (PWE) widely distributed across the country. Although many health institutions have endorsed the use of TM, robust data on effectiveness, safety and costs of TM applied to epilepsy are lacking. TELEmedicine for EPIlepsy Care (TELE-EPIC) will evaluate the effectiveness of video consultation (VC) via TM compared with usual care (UC) for the monitoring of PWE (TELE-EPIC_RCT). Moreover, TELE-EPIC will apply an innovative Volumetric Absorptive Microsampling (VAMS) device for quantitation of ASM through finger prick blood sampling as an alternative to venipuncture sampling (TELE-EPIC_VAMS). Methods and analysis TELE-EPIC_RCT is a multicentre, open, pragmatic two-arm randomised controlled trial prospectively including adult and paediatric outpatients with established diagnosis of epilepsy consecutively attending the Epilepsy Centres of Bologna and Rome, respectively. The primary outcome is the non-inferiority of VC on seizure control compared with UC after an 18-month follow-up. Secondary outcomes are adherence to treatment, ASM-related adverse events, quality of life, mood disorders, patient and caregiver satisfaction, safety and costs. TELE-EPIC_VAMS is a cross-validation study for blood ASM quantitation through a novel, VAMS-based device, comparing (1) VAMS versus plasma samples (reference standard method); and (2) nurse-collected versus self-collected blood by VAMS device. Ethics and dissemination The study has been approved by the local ethics committee (349-2019-SPER-AUSLBO). Complete information about the state of project, relevant events and results will be regularly updated on the project’s webpage on ClinicalTrials.gov. The project’s results and data on the potential impact of TM in epilepsy will be disseminated on social media. A closeout meeting will be convened for the communication and dissemination of the project, highlighting its main achievements and impacts.
Autores :
Marina Trivisano;
Francesca Bisulli;
Paolo Tinuper;
Luca Vignatelli;
Barbara Mostacci;
Elisa Baldin ;
Susan Mohamed;
Corrado Zenesini;
Manuela Contin;
Laura Licchetta;
Autor corporativo:
BMJ Open,
Fecha de publicación:
2021.
Paginas:
1.
ISBN:
2044-6055.
Idioma:
Inglés
Palabras claves:
Telemedicine
EPIlepsy Care
Clinical trial
Público objetivo:
Docentes
Investigadores
Clinicos
Educadores Medicos
Titulo Artículo:
TELEmedicine for EPIlepsy Care (TELE- EPIC): protocol of a randomised, open controlled non-inferiority clinical trial
Resumen:
Introduction Epilepsy is a chronic condition requiring consistent follow-up aimed at seizure control, and monitoring of anti-seizure medication (ASM) levels and side effects. Telemedicine (TM) offers invaluable support to patient follow-up, guaranteeing the prompt availability of a team of experts for persons with epilepsy (PWE) widely distributed across the country. Although many health institutions have endorsed the use of TM, robust data on effectiveness, safety and costs of TM applied to epilepsy are lacking. TELEmedicine for EPIlepsy Care (TELE-EPIC) will evaluate the effectiveness of video consultation (VC) via TM compared with usual care (UC) for the monitoring of PWE (TELE-EPIC_RCT). Moreover, TELE-EPIC will apply an innovative Volumetric Absorptive Microsampling (VAMS) device for quantitation of ASM through finger prick blood sampling as an alternative to venipuncture sampling (TELE-EPIC_VAMS). Methods and analysis TELE-EPIC_RCT is a multicentre, open, pragmatic two-arm randomised controlled trial prospectively including adult and paediatric outpatients with established diagnosis of epilepsy consecutively attending the Epilepsy Centres of Bologna and Rome, respectively. The primary outcome is the non-inferiority of VC on seizure control compared with UC after an 18-month follow-up. Secondary outcomes are adherence to treatment, ASM-related adverse events, quality of life, mood disorders, patient and caregiver satisfaction, safety and costs. TELE-EPIC_VAMS is a cross-validation study for blood ASM quantitation through a novel, VAMS-based device, comparing (1) VAMS versus plasma samples (reference standard method); and (2) nurse-collected versus self-collected blood by VAMS device. Ethics and dissemination The study has been approved by the local ethics committee (349-2019-SPER-AUSLBO). Complete information about the state of project, relevant events and results will be regularly updated on the project’s webpage on ClinicalTrials.gov. The project’s results and data on the potential impact of TM in epilepsy will be disseminated on social media. A closeout meeting will be convened for the communication and dissemination of the project, highlighting its main achievements and impacts.
Fecha de publicación:
2021.
Autor corporativo:
BMJ Open,
.
Idioma:
Inglés
Palabras claves:
Telemedicine
EPIlepsy Care
Clinical trial
Público objetivo:
Docentes
Investigadores
Clinicos
Educadores Medicos
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Hola, encontré este documento en la biblioteca especializada en Educación Médica de ASCOFAME :Marina Trivisano; TELEmedicine for EPIlepsy Care (TELE- EPIC): protocol of a randomised, open controlled non-inferiority clinical trial(2021). Podras consultarlo en el Siguiente link: https://ascofame.org.co/biblioteca/detalle_documento.php?id=1579
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Marina Trivisano Francesca Bisulli Paolo Tinuper Luca Vignatelli Barbara Mostacci Elisa Baldin Susan Mohamed Corrado Zenesini Manuela Contin Laura Licchetta Marina Trivisano Francesca Bisulli Paolo Tinuper Luca Vignatelli Barbara Mostacci Elisa Baldin Susan Mohamed Corrado Zenesini Manuela Contin Laura Licchetta TELEmedicine for EPIlepsy Care (TELE- EPIC): protocol of a randomised, open controlled non-inferiority clinical trial. 2021; 11Ed. 1.
