Ignite Creation Date:
2024-07-17 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499064
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-01
Brief Title:
EOSS-ATTR Study eHealth Based Operative Support System in ATTR-CM
Sponsor:
Hospital Universitari de Bellvitge
Organization:
Hospital Universitari de Bellvitge
Study Overview
Official Title:
Information and Communications Technology ICT-based Modeling of Transthyretin-associated Amyloidosis Cardiomyopathies ATTR-CM Care EOSS-ATTR Study eHealth Based Operative Support System in ATTR-CM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eOSS-ATTR
Brief Summary:
Unicenter proof-of-concept prospective randomised controlled open-label and blinded end-point adjudication trial to assess the effect on patient-reported outcomes measures PROMs patient-reported experience measures PREMs and clinical events of a mHealth-based comprehensive management program for patients with chronic heart failure HF due to transthyretin-associated amyloidosis ATTR-cardiomyopathy CM by means of remote daily telemonitoring of signs and symptoms and remote structured follow-up using videoconference
Detailed Description:
Background and Rationale
Early diagnosis as well as optimal care of transthyretin-associated amyloidosis ATTR-cardiomyopathy CM is crucial to improve the outcome of these patients In order to perform a personalised and patient-centred ATTR-CM it is essential to integrate new advanced diagnostic and monitoring tools to the pre-existing ones In this regard electronic health eHealth-based solutions have been gradually being incorporated into the follow-up of chronic patients eg heart failure HF patients among others over the last few years
Objectives
The main objective of this study is to improve the process of care diagnosis and monitoring of the patient with ATTR-CM by means of a multidisciplinary and transversal model using new digital technologies and optimizing work processes eHealth-based healthcare management The primary objective of the study will be the changes in patient-reported outcomes PROMs such as self-care and quality of life QoL between patients followed and monitored using the mHealth-based digital tool mHealth and those in standard follow-up usual care UC Key secondary objectives will include changes in patient-reported experience measures PREMs the occurrence of events among others between those with and without mHealth-base-ATTR management
Methodology
The eOSS-ATTR study will be a study with 2 phases i Phase 1 a design implantation and pre-clinical evaluation of the digital platform and ii Phase 2 a subsequent clinical evaluation phase The clinical phase Phase 2 will be a unicenter proof-of-concept prospective randomised controlled open-label and blinded end-point adjudication trial to assess the effect on PROMs PREMs and clinical events of a mHealth-based comprehensive management program for patients with HF due to ATTR-CM by means of remote daily telemonitoring of signs and symptoms and remote structured follow-up using videoconference Regarding Phase 1 it is proposed to evolve the MAST Model for Assessment of Telemedicine model adding the consideration of the stakeholders involved in the use of this technology as well as the different use cases and scenarios All assessed items will be compared before and after the eHealth solution implementation Concering Pase 2 HF patients due to ATTR-CM with a HF decompensation in the last 12 months will be randomised 11 to structured follow-up based on face-to-face appointments UC group or the delivery of health care using mHealth mHealth group Randomisation will be stratified at each ATTR subtype variant ATTRv or wild-type form ATTRwt and according to the presence or absence of frailty to ensure balanced assignment of frail patients to each group The follow-up will be of 6 months in two groups and will be nurse-led and based on mHealth solution designed and modeled for the follow-up of patients with ATTR-CM in the mHealth group This technological solution is proposed to improve the care monitoring and outcomes of ATTR-CM patients Patients will be recruited for 12 months
Expected Results
eOSS-ATTR study is the first trial to integrate and assess mHealth solutions combining telemonitoring and structured teleintervention via videoconference in real-world HF patients due to ATTR-CM to improve clinical outcomes and new clinical events Its great value is that it assesses real-world patients in terms of frailty comorbidity literacy level skills with new technologies among others Such strategies are of enormous value for the prognosis QoL and experience of patients with HF due to ATTR-CM Integration of solutions based on mHealth into day-to-day HF monitoring with user-friendly technology that provides the possibility of direct contact with their care team can contribute to a clear clear improvement in PROMs and PREMs as well as a reduction of new clinical events It will allow us to optimise the care of HF due to ATTR-CM patients in this period in terms of self-care education as well as treatment optimisation and empowerment in disease management
Early diagnosis as well as optimal care of transthyretin-associated amyloidosis ATTR-cardiomyopathy CM is crucial to improve the outcome of these patients In order to perform a personalised and patient-centred ATTR-CM it is essential to integrate new advanced diagnostic and monitoring tools to the pre-existing ones In this regard electronic health eHealth-based solutions have been gradually being incorporated into the follow-up of chronic patients eg heart failure HF patients among others over the last few years
Objectives
The main objective of this study is to improve the process of care diagnosis and monitoring of the patient with ATTR-CM by means of a multidisciplinary and transversal model using new digital technologies and optimizing work processes eHealth-based healthcare management The primary objective of the study will be the changes in patient-reported outcomes PROMs such as self-care and quality of life QoL between patients followed and monitored using the mHealth-based digital tool mHealth and those in standard follow-up usual care UC Key secondary objectives will include changes in patient-reported experience measures PREMs the occurrence of events among others between those with and without mHealth-base-ATTR management
Methodology
The eOSS-ATTR study will be a study with 2 phases i Phase 1 a design implantation and pre-clinical evaluation of the digital platform and ii Phase 2 a subsequent clinical evaluation phase The clinical phase Phase 2 will be a unicenter proof-of-concept prospective randomised controlled open-label and blinded end-point adjudication trial to assess the effect on PROMs PREMs and clinical events of a mHealth-based comprehensive management program for patients with HF due to ATTR-CM by means of remote daily telemonitoring of signs and symptoms and remote structured follow-up using videoconference Regarding Phase 1 it is proposed to evolve the MAST Model for Assessment of Telemedicine model adding the consideration of the stakeholders involved in the use of this technology as well as the different use cases and scenarios All assessed items will be compared before and after the eHealth solution implementation Concering Pase 2 HF patients due to ATTR-CM with a HF decompensation in the last 12 months will be randomised 11 to structured follow-up based on face-to-face appointments UC group or the delivery of health care using mHealth mHealth group Randomisation will be stratified at each ATTR subtype variant ATTRv or wild-type form ATTRwt and according to the presence or absence of frailty to ensure balanced assignment of frail patients to each group The follow-up will be of 6 months in two groups and will be nurse-led and based on mHealth solution designed and modeled for the follow-up of patients with ATTR-CM in the mHealth group This technological solution is proposed to improve the care monitoring and outcomes of ATTR-CM patients Patients will be recruited for 12 months
Expected Results
eOSS-ATTR study is the first trial to integrate and assess mHealth solutions combining telemonitoring and structured teleintervention via videoconference in real-world HF patients due to ATTR-CM to improve clinical outcomes and new clinical events Its great value is that it assesses real-world patients in terms of frailty comorbidity literacy level skills with new technologies among others Such strategies are of enormous value for the prognosis QoL and experience of patients with HF due to ATTR-CM Integration of solutions based on mHealth into day-to-day HF monitoring with user-friendly technology that provides the possibility of direct contact with their care team can contribute to a clear clear improvement in PROMs and PREMs as well as a reduction of new clinical events It will allow us to optimise the care of HF due to ATTR-CM patients in this period in terms of self-care education as well as treatment optimisation and empowerment in disease management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None