NCT03207646终止不适用
Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Medication adherence
研究概览
简要总结
This study evaluates a smartphone-based cardiac rehabilitation program in adults with coronary artery disease. Half of patients will participate in a smartphone-based cardiac rehabilitation program while the other half will receive standard-of-care.
详细描述
Cardiac rehabilitation as a means to improve lifestyle-based risk factor modification, remains poorly prescribed and utilized, often due to the lack of access to programs, poor insurance coverage, cost, or patient or physician motivational factors. Low-cost solutions that can improve patient adherence to medications, risk factor reduction, and exercise could improve cardiovascular outcomes and cost-effectiveness compared to current care models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •I. ≥ 18 years of age
- •II. Patient at Stanford Health Care with evidence of CAD (atherosclerosis of one or more coronary arteries or clinical evidence or documentation of ischemia, infarction) OR a diagnosis related to CAD (i.e. ischemic heart disease ICD-10-Code: I20-25).
- •III. Prescription of a P2Y12 antagonist and/or a statin for an anticipated duration of at least 3 months following discharge
- •IV. Possession of a compatible (iPhone 5s or later; OS 8.1 or higher) smartphone with an active phone number and data plan. The smartphone must be in continued possession of the participant. It may not be a shared device and must exclusively remain in the possession of the participant during the study period. The smartphone must have an active cellular phone number and cellular data subscription. Wi-Fi internet capability is not a substitute for an active cellular data plan.
- •V. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •VI. Willing to have the mobile application installed on a smartphone and use it every day during the entire study period VII. Willing to provide oral confirmation indicating that he/she is currently not using a medication adherence application.
- •VIII. Ability to read and understand English.
排除标准
- •Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- •I. Anticipated inability to adhere to the mobile application (BrightHeart®) based on opinion of site Principal Investigator (PI).
- •II. Current use of adherence tracking devices, electronic, smartphone or computer applications, including but not limited to smart pill bottles, pill timers, radiofrequency tagged medications or dispensers, mobile applications, or automated phone reminders. Pill organizers that remind participants when to take medicine with beeps or alerts are exclusion.
- •a. Note: Pharmacy and health care plan automated refill reminders are permitted and are not exclusion. Pill organizers or containers that only compartmentalize a participant's medications based on days of the week are not exclusion.
- •III. Cognitive, visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of mobile phone. Co-morbidities that would preclude participation (e.g. ongoing chemotherapy) or planned hospitalization for complex procedures as determined by the PI (e.g. bypass, valve or aortic surgery, transarterial valve replacement) IV. End-stage of one of the following: heart failure (using left ventricular assist device or listed for heart transplantation), renal disease, lung disease, liver disease.
- •V. Any condition with a life expectancy less than 3 months. VI. Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator VII. Any other condition as determined by the PI.
研究组 & 干预措施
smartphone-based cardiac rehabilitation
Experimental
The BrightHeart® mobile application is installed on the smartphone and a heart coach set up and guides the participant through a cardiac care program.
干预措施: BrightHeart® (Other)
Control
No Intervention
Standard-of-care alone.
结局指标
主要结局
Medication adherence
时间窗: Baseline through End of Study visit - approximately 90 days per participant.
The proportion of days coverd (PDC) expressed as a percentage but considered as a continuous variable of the composite of the prescribed P2Y12 receptor antagonist and/or the statin.
次要结局
- Medication adherence III(Baseline through End of Study visit - approximately 90 days per participant.)
- Medication adherence II(Baseline through End of Study visit - approximately 90 days per participant.)
- Cardiovascular risk factors I(Baseline through End of Study visit - approximately 90 days per participant.)
- Cardiovascular risk factors II(Baseline through End of Study visit - approximately 90 days per participant.)
- Cardiovascular risk factors III(Baseline through End of Study visit - approximately 90 days per participant.)
- Exploratory I: Rehospitalization(Baseline through End of Study visit - approximately 90 days per participant.)
- Medication adherence IV(Baseline through End of Study visit - approximately 90 days per participant.)
- Medication persistence(Baseline through End of Study visit - approximately 90 days per participant.)
- Medication adherence V(Baseline through End of Study visit - approximately 90 days per participant.)
- Cardiovascular risk factors IV(Baseline through End of Study visit - approximately 90 days per participant.)
- Cardiovascular risk factors VI(Baseline through End of Study visit - approximately 90 days per participant.)
- Cardiovascular risk factors V(Baseline through End of Study visit - approximately 90 days per participant.)
- Cardiovascular risk factors VII(Baseline through End of Study visit - approximately 90 days per participant.)
- Exploratory II: Cardiovascular outcomes(Baseline through End of Study visit - approximately 90 days per participant.)
研究者
Mintu Turakhia
Associate Professor of Cardiovascular Medicine
Stanford University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Smartphone Delivered In-home Cardiopulmonary RehabilitationCoronary Artery DiseaseCardiovascular DiseaseNCT02791685Emory University258
招募中
不适用
Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM): A 21st Century Approach for Improving the Self-Management of Heart DiseaseCardiovascular - Coronary heart diseasePhysical Medicine / Rehabilitation - Other physical medicine / rehabilitationCardiovascular diseaseACTRN12618001458224Deakin University220
已完成
不适用
Smartstep Smartphone PADPeripheral Arterial DiseaseNCT03479255Emory University46
已完成
不适用
Technology-Based Intervention to Promote Heart Health After Cardiac Rehab (Mobile4Heart)Ischemic Heart DiseaseCardiovascular DiseasesUnstable AnginaSystolic Heart FailureNCT03446313University of California, San Francisco60
Unknown
不适用
An Integrative Cardiac Rehabilitation Employing Smartphone Technology (iCREST)Myocardial InfarctionNCT05270993National University of Singapore124