Telemedicine in Atrial Fibrillation: Randomized Clinical Trial in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Incidence of bleeding
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Incidence of bleeding
时间窗: one year
Number of bleeding events of any type recorded during follow-up.
Number of hospitalizations
时间窗: one year
Number of hospital admissions for AF decompensation and its associated diseases during the study period.
Health-Related Quality Of Life
时间窗: one year
Measured with EuroQol 5D questionnaire
Therapeutic adherence
时间窗: one year
Measured with MMAS-8 Test (High adherence (8 or \> 8 points), medium (6 or 7 points) and low adherence (5 or \<5 points))
Blood pressure control
时间窗: one year
Measured with systolic and diastolic blood pressure
Number of emergency visits
时间窗: one year
Number of recorded visits to the emergency department in the study months.
Professionals' satisfaction with the mobile application
时间窗: one year
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).
Costs of care
时间窗: one year
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.
Patient satisfaction with the mobile application
时间窗: one year
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).
Incidence of ischemic stroke
时间窗: one year
Measured as the number of recorded ischaemic stroke events in the study months.
Number of visits to primary care
时间窗: one year
Number of registered visits to the primary care service in the study months.
次要结局
未报告次要终点
研究者
Domingo Orozco Beltrán
Professor
Universidad Miguel Hernandez de Elche