Usefulness of a Telemonitoring System to Optimize Continuity of Care From Cardiology to Primary Care in Patients With Chronic Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The 6-min walk distance (6MWD)
研究概览
简要总结
In a randomized clinical trial, a comprehensive telerehabilitation system with a prolonged follow-up strategy demonstrated superiority over a control group with centre-based cardiac rehabilitation in terms of physical activity, VO2 max, adherence to a Mediterranean diet, lipid particle profile and cost-effectiveness. The aim of this study is to demonstrate an extension of the benefit to patients with chronic coronary syndrome in primary care.
详细描述
The patients who have suffered an acute coronary event have a recurrence rate of 2.5% to 15.5% person-years during the first year. Control of cardiovascular risk factors can improve the prognosis of these patients. Following the results of a clinical trial to validate a comprehensive monitoring system called Cardioplan, with a prolonged monitoring strategy, The investigators aim to conduct a study in patients with chronic coronary syndrome in the primary care setting comparing a control group with standard follow-up and a 10-month telemonitored group. Four primary care centres will participate. Two health centres attend mainly a population with a medium-high upper socioeconomic level and the other two mainly a population with a medium-low socioeconomic level. A total of 160 subjects are expected to be included in the follow-up, with 80 subjects in each study group. The primary endpoint is to demonstrate that telemonitored follow-up improves functional exercise capacity compared to usual care, by assessing the distance in meters covered in the 6-minute walk test.
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 (Outcomes Assessor)
盲法说明
The characteristics of the interventions do not allow the study to be blinded either for the patient or for the professional. However, the analyses and surveys will be performed in a masked manner without the assigned group being identified by the investigators who carry out the examinations.
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Patients after more than one year of an acute coronary syndrome of both sexes.
- •Age equal to or less than 72 years.
排除标准
- •Refusal of informed consent
- •Advanced biological age.
- •Kidney failure (GFR < 30ml/min/1.73 m2).
- •Liver failure (GOT >2 times normal value).
- •Ejection fraction less than 50%.
- •Uncontrolled blood pressure (>140/90 mmHg).
- •Uncontrolled heart failure.
- •Dissecting aortic aneurysm.
- •Uncontrolled ventricular tachycardia or other dangerous ventricular arrhythmias.
- •Aortic or mitral valve disease.
- •Recent systemic or pulmonary embolism.
- •Active or recent thrombophlebitis.
- •Acute infectious diseases.
- •Uncontrolled supraventricular arrhythmias or tachycardia.
- •Repeated or frequent ventricular ectopic activity.
- •Moderate pulmonary hypertension.
- •Ventricular aneurysm.
- •Uncontrolled diabetes, thyrotoxicosis, myxedema,
- •Conduction disorders such as: complete atrioventricular block. Left bundle branch block.
- •Wolf-Parkinson-White syndrome.
- •Fixed rate pacing.
- •Severe anaemia.
- •Psychoneurotic disorders.
- •Neuromuscular, musculoskeletal and arthritic disorders that may limit activity. may limit activity.
结局指标
主要结局
The 6-min walk distance (6MWD)
时间窗: 10 months
Meters (m)
次要结局
- Non-HDL cholesterol(10 months)
- smoking cessation(10 months)
- Depression subscale of Emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)(10 months)
- Glycosylated haemoglobin(10 months)
- Health status obtained from the European Quality of Life questionnaire (EuroQol-5D)(10 months)
- GlycA(10 monts)
- Weight(10 months)
- Physical activity derived from the International Physical Activity questionnaire (IPAQ)(10 months)
- Triglycerides(10 months)
- Total cholesterol(10 months)
- Energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire(10 months)
- Anxiety subscale of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)(10 months)
- Body mass Index(10 months)
- Maximal heart rate in the six minute walk test(10 months)
- Visceral fat(10 months)
- High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire(10 months)
- Global score of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)(10 months)
- Global index of the health-related quality of life obtained from the European Quality of Life questionnaire (EuroQol-5D)(10 months)
- Cost-effectiveness analysis(10 months)
- High(10 months)
- Percentage expected for age and sex in the six minute walk test(10 months)
- Neutrophil count(10 monts)
- Lymphocyte count(10 month)
- Small LDL particles(10 months)
- HDL cholesterol(10 months)
- Apolipoprotein B/Apolipoprotein A-I ratio(10 months)
- Waist circumference(10 months)
- Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED).(10 months)
- User's experience from the System Usability Scale (SUS) score(10 months)
- Leukocyte count(10 month)
- Platelet count(10 month)
- LDL cholesterol(10 months)