Effect of Digital Technologies on Risk Factor Modification in Patients After Percutaneous
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Low-density lipoprotein cholesterol level at 6 months
研究概览
简要总结
DigTech investigates the effect of a text message-based intervention to encourage lifestyle change on objective measures of cardiovascular risk in individuals with coronary heart disease (CHD) after percutaneous coronary intervention (PCI).
DigTech will recruit 700 participants from 18-75 years old with CHD after PCI. Half of the participants will be randomised into a 24 week intervention trial, which includes sending 4 personalized short messages about risk factors modification 4 times per week and the other half will be controls.
Participants will complete 3 main study visits:
- Visit 1: Baseline visit conducted at the beginning of the study
- Visit 2: Randomization
- Visit 3: End of study (24 weeks). Each visit will repeat the same set of cardiovascular measures including information about previous treatment, blood pressure, ECG, echocardiography, stress tests, blood sampling, International Physical Activity Questionnaires (IPAQ) and other measures.
详细描述
DESIGN: DigTech is a parallel-group, single-blind, randomized clinical trial investigating the changes in cardiovascular risk factors (low-density lipoprotein cholesterol [LDL-C] level, blood pressure, body mass index [BMI]) according to personalized intervention, based on individual short messages in CHD patients after PCI.
BACKGROUND AND AIMS:
Cardiovascular disease prevention, including lifestyle modification, is important but underutilized. Mobile health strategies could address this gap but lack evidence of therapeutic benefit.
This trial aims at the examination of the effect of a lifestyle-focused personalized support program delivered by mobile phone text message on cardiovascular risk factors.
PARTICIPANTS: 700 participants aged 18-75 with CHD after PCI.
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
- Single (Investigator)
盲法说明
Investigators who will perform follow-up will be masked
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with coronary artery disease at the age of 18 to 75 years who are planning PCI for hemodynamically significant coronary artery stenosis.
排除标准
- •Severe comorbidities (malignant tumors, severe lung diseases, marked cognitive impairment).
- •Severe CHF (EF LV <35% or functional class of heart failure III-IV NYHA).
- •Severe valvular heart disease or Prosthetic heart valves.
- •Severe diseases of the musculoskeletal system.
- •The patient's reluctance to participate in the study.
研究组 & 干预措施
Digital technology
standard cardiac rehabilitation program + 4 personalized short messages about risk factors modification 4 times per week
干预措施: Digital technology (Behavioral)
Control
standard cardiac rehabilitation program
结局指标
主要结局
Low-density lipoprotein cholesterol level at 6 months
时间窗: 6 months
The primary end point was low-density lipoprotein cholesterol level at 6 months
次要结局
- Body mass index (BMI)(6 months)
- Systolic blood pressure(6 months)