Smartphone based application for drug adherence and risk factor modification in outpatients with coronary artery disease – an open label randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Medication adherence will be measured by assessing the number of adherence failure events (defined as 1 missed dose during a observation cycle of 30 days) using pill counting method and Medication adherence score.
研究概览
简要总结
This is a Digital health intervention randomized controlled trial analyzing an Android smartphone application for achieving risk factor modification and medication adherence in stable coronary artery disease patients for six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 16.00 Year(s) 至 64.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with clinically documented stable CAD attending cardiology OPD of JIPMER hospital.
- •18 years to 64 years
- •Able to use a smart phone with android function
- •Able to read English or Tamil.
排除标准
- •Recent ACS or PCI within 1 month
- •Patients awaiting revascularization
- •Has visual, auditory, cognitive or motor impairment
- •COPD, Peripheral Vascular Disease, Post Pacemaker
- •Recent CABG within 6 months.
结局指标
主要结局
Medication adherence will be measured by assessing the number of adherence failure events (defined as 1 missed dose during a observation cycle of 30 days) using pill counting method and Medication adherence score.
时间窗: Medication adherence will be measured by assessing the number of adherence failure events (defined as 1 missed dose during a observation cycle of 30 days) using pill counting method. | Improvement of CV risk factor targets (defined before).
Improvement of CV risk factor targets (defined before).
时间窗: Medication adherence will be measured by assessing the number of adherence failure events (defined as 1 missed dose during a observation cycle of 30 days) using pill counting method. | Improvement of CV risk factor targets (defined before).
次要结局
- Change in Quality of Life, Stress level and Quality of sleep are the secondary outcomes measured at baseline, 12 weeks and 24 weeks(3)