Effect of Targeted Education for Atrial Fibrillation Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,040
- 试验地点
- 3
- 主要终点
- Cardiovascular events
研究概览
简要总结
The aim of this study is to evaluate the effect of targeted in-person and online education on cardiovascular outcomes of AF patients (inpatient and outpatient), compared with standard care. Several other parameters (i.e. knowledge level, quality of life, symptom burden, self-care capabilities, adherence to oral anticoagulation, and an evaluation of the educational efforts) will be studied. Cost-effectiveness and cost-utility will also be investigated.
The main research hypothesis is that individualized education based on the knowledge gaps measured with the JAKQ (Jessa Atrial fibrillation Knowledge Questionnaire) in each individual patient (called 'targeted education') is superior when compared to current AF care, both from an efficacy perspective (evaluated by different outcome measures) and from a cost-effectiveness perspective.
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
研究组 & 干预措施
In-person education
Education will be given on a regular basis via predefined consultation visits. Medication adherence (oral anticoagulation) will also be measured using a special cap that fits on a medication bottle. If adherence is low, the patient will get additional feedback when he does not take this medication as prescribed.
干预措施: Education (Other)
Standard Care
This group of AF patients will serve as a control group and no extra focused educational reinforcements will be provided beyond standard care (i.e. information of the treating physician and a brochure).
Online education
Education will be given on a regular basis via a special designed online platform. Medication adherence (oral anticoagulation) will also be measured using a special cap that fits on a medication bottle. If adherence is low, the patient will get additional feedback when he does not take this medication as prescribed.
干预措施: Education (Other)
结局指标
主要结局
Cardiovascular events
时间窗: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
The occurrence of a composite endpoint of cardiovascular death, cardiovascular hospitalizations (first and recurrent) and unplanned cardiovascular or neurological consultations (first and recurrent).
次要结局
- Patients' knowledge level, assessed by the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ)(at baseline, 1 month, 3-, 6-, 12- and 18 months and if applicable at 24-, 30- and 36 months or at the end of the study in the intervention groups. In the standard care group at 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-, 12- and 18 months and if applicable at the end of the study in the intervention groups. In the standard care group at baseline and 18 months and if applicable at the end of the study.)
- Patients' symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ).(at baseline, 3-,12- and 18 months and if applicable at the end of the study in the intervention groups. In the standard care group at baseline and 18 months and if applicable at the end of the study.)
- Patients' self-care capabilities, assessed by the Self-Care Questionnaire (SCQ)(at baseline, 3-,12- and 18 months and if applicable at the end of the study in the intervention groups. In the standard care group at baseline and 18 months and if applicable at the end of the study.)
- Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS).(monitoring between 0-3 months and 12-15 months and feedback during 3-6 months and 15-18 months in those patients with a low adherence in the intervention groups)
- Patients' satisfaction of the intervention will be assessed by a study specific Patient Reported Outcome Measure (PROM) questionnaire.(at 12 months in the intervention groups and 18 months in the standard care group.)
- Mortality(Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).)
- (Un)planned hospital admissions(Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).)
- Hospital duration(Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).)
- (Un)planned cardiovascular and neurological visits(Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).)
- Cardiovascular emergency department visits(Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).)
- General practitioner visits(Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).)
研究者
Prof. Dr. Hein Heidbuchel
Professor Doctor
Universiteit Antwerpen