NCT05893199

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

Telemedicine in Atrial Fibrillation: Randomized Clinical Trial in Primary Care

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Universidad Miguel Hernandez de Elche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Clinical monitoring using the Ti.Care app (https://ti.care/es)	Clinical monitoring using the Ti.Care app (https://ti.care/es)
OTHER	Usual care	usual follow-up in primary care both arms

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-12-31
• Completion: 2025-06-30
• First posted: 2023-06-07
• Last updated: 2023-06-07