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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Improvement of quality of life using a validated questionnaire (EUROQOL - 5D).
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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
结局指标
主要结局
Improvement of quality of life using a validated questionnaire (EUROQOL - 5D).
时间窗: Six months after inclusion of the patient
Comparison of both strategies at the end of follow-up.
Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale).
时间窗: 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 \[UC\]).
次要结局
- Incidence of implantation of devices (pacemakers, cardiac resynchronization therapy [CRT] or implantable cardioverter defibrillator [ICD])(Six months after inclusion of the patient)
- Change of 6-minutes walking test [6MWT] distance.(Six months after inclusion of the patient)
- 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).(Six months after inclusion of the patient)
- Change of NYHA functional class(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]).(Six months after inclusion of the patient)
- Evolution of ATTR-CM stages(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]).(Six months after inclusion of the patient)
研究者
Sergi Yun
Internal Medicine Specialist. MD. Principal investigator
Hospital Universitari de Bellvitge