Telemedicine in Atrial Fibrillation: Randomized Clinical Trial in Primary Care (AtrialConnect)

Miguel Hernández University of Elche

Status: Not yet enrolling

Conditions: Atrial Fibrillation

Treatments: Other: Usual care; Device: Clinical monitoring using the Ti.Care app (https://ti.care/es)

Study type: Interventional

Funder types: Other

Identifiers

NCT05893199

AtrialConnect

Details and patient eligibility

About

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the world, with a large consumption of health resources. Telemedicine represents a new model of care, facilitating the individual approach to each patient and reducing costs and complications.

This is an an open-label, randomized, multicenter, clinical trial aiming to analyze the use of telemedicine with AF patients in real clinical practice at primary care in terms of efficacy, efficiency, patient perception and professional satisfaction.

The intervention will be based on the use of the Ti.Care app as the telemedicine support, in addition to the usual care. The follow-up will be carried out for 12 months.

Full description

Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia in the world, with a prevalence between 2-4%. Given the increase in prevalence, its associated morbidity and mortality, and the large consumption of health resources there has been a need to adapt health care models. Telemedicine and the use of mobile devices represent a new model of care for chronic patients, facilitating the individual approach to each patient and reducing the disability associated with their chronic pathology.

Objective: To analyze the use of telemedicine in patients with atrial fibrillation in real clinical practice in primary care trying in terms of efficacy (blood pressure control, incidence of ischemic stroke, incidence of bleeding), efficiency (number of visits to the clinic, hospitalizations, costs of care), patient perception (quality of life, therapeutic adherence, satisfaction with the mobile App) and professional satisfaction (satisfaction with the mobile App and benefits of its use in the clinic).

Methods: The investigators propose to conduct an open-label, randomized, multicenter clinical trial. The intervention will be based on the use of the Ti.Care app as the telemedicine support, in addition to the usual care with their primary care physician (PCP). The control group will perform the usual follow-up with their PCP. The follow-up will be carried out for 12 months, and is proposed as an effective and cost-efficient improvement for the national health system and for the patient.

Key words: Telemedicine, Mobile Applications, Atrial Fibrillation, Primary Health Care.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age diagnosed with AF.
• Without difficulties in using the mobile App or patients with difficulties in using the mobile App but with good family or caregiver support, who understand its use.

Exclusion criteria

• Terminally ill patient.
• Refusal to participate on the part of the patient
• Difficulties in understanding the contents of the mobile App (cognitive impairment, dependence for activities of daily living, etc.) and no enabling family support

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Telemedicine

Experimental group

Description:

Patients in the intervention group (Telemedicine) will be followed up using the Ti.Care App in addition to the usual primary care follow-up.

Treatment:

Other: Usual care

Device: Clinical monitoring using the Ti.Care app (https://ti.care/es)

Primary care

Active Comparator group

Description:

Patients in the control group will be followed up exclusively in primary care.

Treatment:

Other: Usual care