An interventional study of Clinical monitoring using the Ti.Care app (https://ti.care/es) and Usual care in Atrial Fibrillation, sponsored by Universidad Miguel Hernandez de Elche. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-07.
Sponsored by Universidad Miguel Hernandez de Elche · Not applicable, Interventional, and Supportive care
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 180 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Universidad Miguel Hernandez de Elche is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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) · Other: Usual care
Patients in the control group will be followed up exclusively in primary care.
Other: Usual care
Clinical monitoring using the Ti.Care app (https://ti.care/es)
usual follow-up in primary care both arms
Blood pressure control
Measured with systolic and diastolic blood pressure
Time frame: one year
Incidence of ischemic stroke
Measured as the number of recorded ischaemic stroke events in the study months.
Time frame: one year
Incidence of bleeding
Number of bleeding events of any type recorded during follow-up.
Time frame: one year
Number of emergency visits
Number of recorded visits to the emergency department in the study months.
Time frame: one year
Number of hospitalizations
Number of hospital admissions for AF decompensation and its associated diseases during the study period.
Time frame: one year
Number of visits to primary care
Number of registered visits to the primary care service in the study months.
Time frame: 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.
Time frame: one year
Health-Related Quality Of Life
Measured with EuroQol 5D questionnaire
Time frame: 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))
Time frame: 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).
Time frame: 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).
Time frame: one year
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Universidad Miguel Hernandez de Elche