A Mobile Relational Agent to Enhance Atrial Fibrillation Self-care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 2
- 主要终点
- Proportion of Days Covered
研究概览
简要总结
Atrial fibrillation (AF) is a common, morbid condition with increasing prevalence. Poor health-related quality of life is common in AF. Patients experience debilitating symptoms and challenging adherence to long-term (possibly lifelong) anticoagulation. The increased risks of stroke, heart failure and mortality associated with AF persist even with optimal treatment. Morbidity in AF is further exacerbated by social factors. Limited health literacy carries challenges of learning a specialized terminology and navigating specialized treatments. In multiple cardiovascular diseases, self-care has demonstrated improvement in self-efficacy, health-related quality of life, symptom burden, and health care utilization - essential components of patient success with AF. Selfcare can provide the critical skills to navigate a challenging chronic disease and improve patient-centered outcomes. Delivery of self-care as a mobile health intervention can complement standard care with a longitudinal intervention to improve patient-centered strategies for AF. While self-care interventions for AF have focused foremost on self-monitoring of anticoagulation,self-care has demonstrated its potential to meet the "triple aim" of improved patient experience, reduced health care utilization, and lower costs.
详细描述
This is a randomized clinical trial to evaluate the effect of a smartphone-based intervention called a relational agent on health outcomes in people with atrial fibrillation. The study will enroll 240 patients who reside in Pittsburgh-area with this condition and will randomize them to the intervention or control. Intervention participants will receive a smartphone with the agent, which simulates conversation. In addition they will receive an AliveCor Kardia for heart rate and rhythm monitoring, an FDA-approved, widely used instrument that pairs with the smartphone. Control participants will receive a smartphone with WebMD, a brochure published by the American Heart Association that describes AF, and an AliveCor Kardia. The intervention will last 4 months and participants will have visits at baseline, 4, 8 and 12 months. The study will evaluate the improvement in quality of life, medical adherence and health care utilization resulting from the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, age ≥21;
- •Diagnosis of AF, identified from the electronic health record problem list and confirmed by 2 or more reports of AF from separate monitoring events at least 2 weeks apart (electrocardiogram, Holter or event monitor);
- •CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke or transient ischemic attack, coronary heart disease, female sex)≥2;
- •Prescribed use of warfarin or direct-acting oral anticoagulant for AF stroke prevention;
- •English-speaking well enough to participate in informed consent and this study;
- •No plans to relocate from the area within 12 months of enrollment.
排除标准
- •Conditions other than AF that require anticoagulation, such as mechanical prosthetic valve, deep vein thrombosis, or pulmonary embolism;
- •History of pulmonary vein isolation or foreseen pulmonary vein isolation;
- •History of atrioventricular nodal ablation or foreseen atrioventricular nodal ablation;
- •Heart failure necessitating hospital admission ≤3 months prior to study inclusion;
- •Acute coronary syndrome (defined as at least 2 of the following: chest pain, ischemic electrocardiographic changes, or troponin ≥0.1 ng/mL) ≤3 months prior to study inclusion;
- •Untreated hyperthyroidism or ≤3 months euthyroidism before inclusion;
- •Foreseen pacemaker, internal cardioverter defibrillator, or cardiac resynchronization therapy;
- •Cardiac surgery ≤3 months before inclusion;
- •Planned cardiac surgery;
- •Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer);
- •Inability to comprehend the study protocol, defined as failing to answer correctly a set of questions on orientation and short-term memory during the consent process.
结局指标
主要结局
Proportion of Days Covered
时间窗: 12 months
Proportion of Days Covered (PDC), obtained from collection of electronic prescription and pharmacy fill data, and defined as the proportion of availability of medication for the period of interest, here the period from the date of the baseline to the 12-month examination. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication over the 12-month period of study participation as indicated by pharmacy records.
次要结局
- Days of Hospitalization(12 months)
- Self-reported Non-adherence(4, 8 and 12 months)
- Atrial Fibrillation Effect on Quality of Life (AFEQT)(4, 8 and 12 months)
- Emergency Room (ER) Visits and Hospitalizations(12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS)-29(4, 8, and 12 months)
研究者
Jared W Magnani, MD, MSc
Associate Professor
University of Pittsburgh