Heart FailureeOSS-ATTRNCT06499064
EOSS-ATTR Study (eHealth Based Operative Support System in ATTR-CM)
A study testing mHealth in people with Heart Failure and Amyloid Cardiomyopathy, run by Hospital Universitari de Bellvitge.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Amyloid Cardiomyopathy, ATTR Amyloidosis Wild Type
- What is being tested?
- mHealth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- HF diagnosis according to European Society of Cardiology (ESC)
- Patients with a HF decompensation in the last 12 months
- Confirmed diagnosis of ATTR-CM (ATTRv or ATTRwt)
- Written informed consent
Who cannot join
- Age<18 years old
- Participation in another clinical trial
- Moderate or severe cognitive impairment without a competent caregiver
- Lack of social support
- Institutionalized patients
- Life expectancy less than 1 year (excluding HF)
Show all 14Show fewer
- Institutional-based or end-of-life care
- Serious psychiatric illness
- Planned cardiac surgery
- Planned heart transplantation or left ventricular assist device (LVAD) implant
- Patients in haemodialysis program
- The patient is unable or unwilling to give the informed consent to participate
- The patient is considered an unsuitable candidate for this study according to the decision of the local investigator
- Unstable patients with signs of fluid overload or low cardiac output
Trial locations and contacts
No sites are listed yet.
About this study
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)
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.
Read the 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 (e.g. 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 (1:1) 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.
- Being tested
- mHealth
- Keywords
- eHealth; mHealth; telemonitoring; ATTR, heart failure
- Medical subject headings
- Heart Failure, Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealthProcedure or surgery
Follow-up and treatment of patients in the mHealth arm will be based on a comprehensive solution for the care and monitoring of chronic patients, modelled and tested in chronic HF patients. This is the PIRENe platform, previously described and evaluated in HF patients. It is a digital solution, external to the centre's information systems (external platform). However, it has some special features in its design in terms of remote monitoring, educational tools, among others, expressly conceived and designed for patients with ATTR-CM. This platform allows the provision of multichannel service and monitoring of patients through:
- Patient monitoring of: Biometric data and symptom report.
- Generation and management of warning alarms notified to the professionals assigned to each patient in case one of the following situations occurs.
- Follow-up via videoconference.
| Study group | Role | What they receive |
|---|---|---|
| mHealth | Experimental | Structured follow-up in the basis of using mHealth-based solution. mHealth will include daily signs and symptoms telemonitoring and structured follow-up by the means of video or audio-conference. Receives: Procedure: mHealth |
| Usual care | No intervention | Patients with usual care follow-up in a heart failure due to ATTR-CM program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale).
changes in patient-reported outcomes (PROMs) such as self-care European Heart Failure Self-Care Behaviour Scale) between patients followed and monitored using the mHealth-based digital tool (mHealth) and those in standard follow-up (usual care [UC]).
Measured: Six months after inclusion of the patient
Improvement of quality of life using a validated questionnaire (EUROQOL - 5D).
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient
Secondary outcomes (7)
Occurrence of new clinical events (readmission [all-cause, HF, CV and non-CV] rate and total number; worsening HF events; urgent HF visits; all-cause, CV and non-CV death).
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient
Incidence of implantation of devices (pacemakers, cardiac resynchronization therapy [CRT] or implantable cardioverter defibrillator [ICD])
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient
Change of NYHA functional class
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient
Change of 6-minutes walking test [6MWT] distance.
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient
Evolution of ATTR-CM stages
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient
Changes in prognostic biomarkers: atrial natriuretic peptide levels (brain natriuretic peptide [BNP] and/or N-terminal-pro-brain natriuretic peptide [NT-proBNP]) and troponin levels (troponin T [TnT] and/or troponin I [TnI]).
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient
Improvement of patient reported experience measures such as IEXPAC questionnaire (Instrumento de Evaluación de la eXperiencia del PAciente Crónico) or Evaluation Tool of the Chronic Patient Experience and patient satisfaction (Net Promoter Score [NPS]).
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Dec 2024 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge
- Responsible party
- Principal investigator, Sergi Yun, Hospital Universitari de Bellvitge
- Investigators
- Sergi Yun Viladomat, MD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499064
- Sponsor's protocol ID
- IDIBELL-PR361/23
- Acronym
- eOSS-ATTR
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06499064
- Acronym / sponsor ID
- eOSS-ATTR / IDIBELL-PR361/23
- Keywords
- eHealth; mHealth; telemonitoring; ATTR, heart failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (e.g. 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 (1:1) 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth | Experimental | Procedure: mHealthStructured follow-up in the basis of using mHealth-based solution. mHealth will include daily signs and symptoms telemonitoring and structured follow-up by the means of video or audio-conference. |
| Usual care | No intervention | –Patients with usual care follow-up in a heart failure due to ATTR-CM program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- HF diagnosis according to European Society of Cardiology (ESC)
- Patients with a HF decompensation in the last 12 months
- Confirmed diagnosis of ATTR-CM (ATTRv or ATTRwt)
- Written informed consent
Key exclusion criteria (14 listed)
- Age<18 years old
- Participation in another clinical trial
- Moderate or severe cognitive impairment without a competent caregiver
- Lack of social support
- Institutionalized patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealthFollow-up and treatment of patients in the mHealth arm will be based on a comprehensive solution for the care and monitoring of chronic patients, modelled and tested in chronic HF patients. This is the PIRENe platform, previously described and evaluated in HF patients. It is a digital solution, external to the centre's information systems (external platform). However, it has some special features in its design in terms of remote monitoring, educational tools, among others, expressly conceived and designed for patients with ATTR-CM. This platform allows the provision of multichannel service and monitoring of patients through: 1. Patient monitoring of: Biometric data and symptom report. 2. Generation and management of warning alarms notified to the professionals assigned to each patient in case one of the following situations occurs. 3. Follow-up via videoconference. | Procedure or surgery | mHealth |
Primary outcome
Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale).
Time frame: Six months after inclusion of the patient
changes in patient-reported outcomes (PROMs) such as self-care European Heart Failure Self-Care Behaviour Scale) between patients followed and monitored using the mHealth-based digital tool (mHealth) and those in standard follow-up (usual care [UC]).
Improvement of quality of life using a validated questionnaire (EUROQOL - 5D).
Time frame: Six months after inclusion of the patient
Comparison of both strategies at the end of follow-up.
7 secondary outcomes
Occurrence of new clinical events (readmission [all-cause, HF, CV and non-CV] rate and total number; worsening HF events; urgent HF visits; all-cause, CV and non-CV death).
Time frame: Six months after inclusion of the patient
Incidence of implantation of devices (pacemakers, cardiac resynchronization therapy [CRT] or implantable cardioverter defibrillator [ICD])
Time frame: Six months after inclusion of the patient
Change of NYHA functional class
Time frame: Six months after inclusion of the patient
Change of 6-minutes walking test [6MWT] distance.
Time frame: Six months after inclusion of the patient
Evolution of ATTR-CM stages
Time frame: Six months after inclusion of the patient
Changes in prognostic biomarkers: atrial natriuretic peptide levels (brain natriuretic peptide [BNP] and/or N-terminal-pro-brain natriuretic peptide [NT-proBNP]) and troponin levels (troponin T [TnT] and/or troponin I [TnI]).
Time frame: Six months after inclusion of the patient
Improvement of patient reported experience measures such as IEXPAC questionnaire (Instrumento de Evaluación de la eXperiencia del PAciente Crónico) or Evaluation Tool of the Chronic Patient Experience and patient satisfaction (Net Promoter Score [NPS]).
Time frame: Six months after inclusion of the patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergi Yun Viladomat, MD principal investigator
Hospital Universitari de Bellvitge
Questions about this trial
What is this clinical trial studying?
A study testing mHealth in people with Heart Failure and Amyloid Cardiomyopathy, run by Hospital Universitari de Bellvitge.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergi Yun Viladomat, MD (+34 93 260 7078, sergi.yun@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale). (time frame: Six months after inclusion of the patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.