Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Blood pressure at target level (140/85 or lower), total cholesterol at target level (4.5 mmol/l or lower), LDL cholesterol at target level (2.5 mmol/l or below), waist circumference at target level (<=94 men, <=80 cm women)
研究概览
简要总结
A randomised trial with individual patients as units of observation will be carried out. Health coaching is used to modify health behaviour and thus improve disease control and health status, as well as use of health care services. A personal health coach is assigned to each patient and they are in weekly contact through telephone. The intervention lasts for 12 months. No intervention is offered to the patients in the control arm.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes (medication and HbA1c>7% and no cardiovascular disease), coronary artery disease (history of myocardial infarction or revascularisation) or heart failure (NYHA II-III and admitted in a hospital for the condition within 2 years)
- •Aged 45 years or older
- •Resident in the Päijät-Häme health care district
排除标准
- •Classified as ineligible by primary care physician
- •Unable to co-operate or participate in health coaching
- •Major elective surgery planned within 6 months
- •History of major surgery within past 2 years
- •Life expectancy <1 year
- •Pregnancy
结局指标
主要结局
Blood pressure at target level (140/85 or lower), total cholesterol at target level (4.5 mmol/l or lower), LDL cholesterol at target level (2.5 mmol/l or below), waist circumference at target level (<=94 men, <=80 cm women)
时间窗: 12 months from start of intervention
For patients with diabetes: blood HbA1c at target level (7% or less)
时间窗: 12 months from start of intervention
次要结局
- Improvement in body mass index, health-related quality of life (15D instrument), amount of exercise, diet, smoking cessation; for patients with heart failure also use of emergency services and NYHA class(12 months from start of intervention)