Mobile Health Intervention for Rural Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 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 highly prevalent, morbid condition. Anticoagulation to prevent thromboembolic strokes is a foremost priority in AF but adherence is challenging for patients and lapses in anticoagulation are common. Chronic disease self-management (CDSM) is a recognized program to enhance self-efficacy and improve adherence, quality of life, and patient-centered health outcomes. Rural patients with AF experience increased vulnerability to adverse outcomes due to geographic and social isolation, poor health care access, and limited health literacy. This study uses an innovative, scalable CDSM intervention to improve anticoagulation adherence in rural patients with AF.
详细描述
This is a randomized clinical trial to evaluate the effect of an embodied conversational agent (ECA) on health outcomes in people with atrial fibrillation. The study will enroll 264 patients who reside in rural, Western Pennsylvania who have atrial fibrillation. Participants will be randomized to the intervention or usual care. Intervention participants will receive a contemporary mobile phone, commonly known and referred to herein as a smartphone, with a relational agent, which simulates conversation and provides coaching, guidance, and assistance with chronic disease self-management. In addition participants will receive an FDA-approved instrument for heart rate and rhythm monitoring, which is named the "AliveCor KardiaMobile" device (herein referred to as the AliveCor Kardia), that pairs with the relational agent. Usual care participants will receive a smartphone as well, which will have the general health application called "WebMD." 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 adherence to anticoagulation, quality of life, 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 (EHR) problem list and confirmed by 2 or more reports of AF from separate monitoring events at least 2 weeks apart (CG, Holter or event monitor);
- •Prescribed use of warfarin or direct-acting oral anticoagulant (DOAC) 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 (AV) nodal ablation or foreseen AV 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. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication as indicated by pharmacy records.
Self-reported Adherence
时间窗: 4, 8, and 12 months
Self-reported adherence to oral anticoagulation. 3-item instrument with range 1-5 such that lower scores indicate more frequent medication adherence. Here the score is dichotomized by classifying participants reporting 1 for all three items as adherent and those that reported ≥ 2 on any item as non-adherent.
次要结局
- Atrial Fibrillation Effect on Quality of Life (AFEQT)(4, 8, and 12 months)
- Emergency Room Visits(12 months)
- Hospital Admissions(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