EOSS-ATTR Study (eHealth Based Operative Support System in ATTR-CM)

NCT06499064 | Not Yet Recruiting

• 1 other identifier: IDIBELL-PR361/23
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; Amyloid Cardiomyopathy; ATTR Amyloidosis Wild Type; ATTR Gene Mutation

Keywords

eHealth; mHealth; telemonitoring; ATTR, heart failure

Outcome Measures

Primary Outcomes (2)

• 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 \[UC\]).

  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.

  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).

  Six months after inclusion of the patient

• Incidence of implantation of devices (pacemakers, cardiac resynchronization therapy [CRT] or implantable cardioverter defibrillator [ICD])

  Six months after inclusion of the patient

• Change of NYHA functional class

  Six months after inclusion of the patient

• Change of 6-minutes walking test [6MWT] distance.

  Six months after inclusion of the patient

• Evolution of ATTR-CM stages

  Six months after inclusion of the patient

Study Arms (2)

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.

Procedure: mHealth

Usual care

NO INTERVENTION

Patients with usual care follow-up in a heart failure due to ATTR-CM program.

Interventions

mHealth PROCEDURE

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: 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.

mHealth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator

MeSH Terms

Conditions

Heart Failure; Amyloid Neuropathies, Familial

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Sergi Yun Viladomat, MD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergi Yun Viladomat, MD

CONTACT

+34 93 260 7078; sergi.yun@bellvitgehospital.cat

Cristina Enjuanes Grau, PhD

CONTACT

+34 93 260 7078; cenjuanes@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine Specialist. MD. Principal investigator

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 12, 2024
• Study Start: December 1, 2024
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share