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

Study Overview
=================
Brief 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.

Official Title
-----------------
Telemedicine in Atrial Fibrillation: Randomized Clinical Trial in Primary Care

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Clinical monitoring using the Ti.Care app (https://ti.care/es)
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine<br>Patients in the intervention group (Telemedicine) will be followed up using the Ti.Care App in addition to the usual primary care follow-up. | Device: Clinical monitoring using the Ti.Care app (https://ti.care/es)<br>* Clinical monitoring using the Ti.Care app (https://ti.care/es)<br>Other: Usual care<br>* usual follow-up in primary care both arms<br>|
| Active Comparator: Primary care<br>Patients in the control group will be followed up exclusively in primary care. | Other: Usual care<br>* usual follow-up in primary care both arms<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure control | Measured with systolic and diastolic blood pressure | one year | 
| Incidence of ischemic stroke | Measured as the number of recorded ischaemic stroke events in the study months. | one year | 
| Incidence of bleeding | Number of bleeding events of any type recorded during follow-up. | one year | 
| Number of emergency visits | Number of recorded visits to the emergency department in the study months. | one year | 
| Number of hospitalizations | Number of hospital admissions for AF decompensation and its associated diseases during the study period. | one year | 
| Number of visits to primary care | Number of registered visits to the primary care service in the study months. | one year | 
| Costs of care | The indexes and prices of the Consejería de Sanidad for each type of consultation or hospitalisation and the established retail prices in the year of the study for medicines will be used. | one year | 
| Health-Related Quality Of Life | Measured with EuroQol 5D questionnaire | one year | 
| Therapeutic adherence | Measured with MMAS-8 Test (High adherence (8 or > 8 points), medium (6 or 7 points) and low adherence (5 or <5 points)) | one year | 
| Patient satisfaction with the mobile application | Measured by the survey on satisfaction and perception of the use of new technologies in the field (designed for the study). Scoring: High satisfaction (4 or 5 points), medium (3 points), low satisfaction (1 or 2 points). | one year | 
| Professionals' satisfaction with the mobile application | Measured by the survey on satisfaction and perception of the use of new technologies in the field (designed for the study). Scoring: High satisfaction (5-7 points), medium (3 or 4 points), low satisfaction (1 or 2 points). | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemedicine, Atrial Fibrillation, Primary care, Patient perception, Quality of life, Efficacy, Efficiency, Job Satisfaction, Patient safety, Mobile Applications