Effect of Targeted Education for Atrial Fibrillation Patients (Application Substudy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS).
研究概览
简要总结
The aim of this study is to evaluate a new and innovative educational application based on targeted education on the adherence level for NOACs (non-vitamin K antagonist oral anticoagulants) in AF patients, compared with standard care, online targeted education and in-person targeted education.
Several other parameters (knowledge level, quality of life, symptom burden, self-care capabilities, evaluation of educational efforts) will be studied. If resources allow, cardiovascular outcomes, cost-effectiveness and cost-utility will also be investigated.
详细描述
This substudy is part of the AF-EduCare study (NCT03707873): an extra study arm will be added to the main trial in which eligible AF patients (= in possession of a smartphone and capable working with their smartphone) will test this new educational application. Not eligible patients randomized to this group, will receive standard care.
This extra study arm will additionally include an anticipated 221 patients (eligible plus not eligible patients).
[An anticipated total of 1259 AF patients will be included for the AF-EduCare study (1038 AF patients) plus the AF-EduApp substudy (221 AF patients).]
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age ≥ 18 years.
- •Patients in whom AF or atrial flutter is diagnosed with an electrocardiogram (12-lead, holter,...).
- •Patients who are capable to sign the informed consent.
排除标准
- •Not able to speak and read Dutch.
- •Cognitive impaired (e.g. severe dementia).
- •Life expectancy is estimated to be less than 1 year.
- •Ongoing participation in another clinical trial.
- •Pregnant women
结局指标
主要结局
Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS).
时间窗: Monitored between 0-12 months and 12-15 months if resources allow.
次要结局
- Patients' knowledge level, assessed by the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ)(at baseline,1 month,3-,6-,12 months in the application group.(+18-and if applicable at 24-,30-,36 months/at the end of the study in the other intervention groups).In the standard care groups at 12 or 18 months (if applicable at the end of the study).)
- Patients' self-care capabilities, assessed by the Self-Care Questionnaire (SCQ).(at baseline, 3- and 12 months in the application group. (+18-and if applicable 36 months/at the end of the study in the other intervention groups).In the standard care groups at baseline and 12 or 18 months (and if applicable at the end of the study).)
- Patients' quality of life, assessed by the EQ-5D-3L questionnaire and the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire.(at baseline, 3- and 12 months in the application group.(+18-and if applicable at 36 months/at the end of the study in the other intervention groups.) In the standard care groups at baseline and 12 or 18 months (and if applicable at the end of the study).)
- Patients' quality of life, assessed by the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire.(at baseline and 12 months in the application group.(+18-and if applicable at 36 months/at the end of the study in the other intervention groups.) In the standard care groups at baseline and 12 or 18 months (and if applicable at the end of the study).)
- Patients' symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ).(at baseline,3- and 12 months in the application group.(+18-and if applicable at 36 months/at the end of the study in the other intervention groups).In the standard care groups at baseline and 12 or 18 months (and if applicable at the end of the study).)
- Patients' satisfaction of the intervention will be assessed by a study specific Patient Reported Outcome Measure (PROM) questionnaire.(at 12 months in all intervention groups and 12 or 18 months in the standard care groups.)
研究者
Hein Heidbuchel
Professor Doctor
University Hospital, Antwerp