Swiss Secondary Prevention and Rehabilitation Registry: SwissPR
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Change in Guideline recommended medical therapy
研究概览
简要总结
The SwissPR study is to continuously monitor patient characteristics and short- and long-term benchmark quality measures and outcomes of patients participating in a 12-week ambulatory CR program.
详细描述
The SwissPR study is a non-interventional, longitudinal observational cohort study consisting of a retrospective and a prospective part of patients who have completed the Cardiac Rehabilitation (CR) program of the University Hospital Basel. Assessing the impact of a CR program on key cardiovascular Benchmark Performance Measures (BPM) and its persistence over time would be helpful on internal quality control as well as identification of special need patients with highest cardiovascular risk. "KARAMBA" is the outpatient cardiovascular prevention and rehabilitation program of the University Hospital Basel (USB) and is one of the largest CR centers in Switzerland. Data regarding the Swiss population during and after CR is missing so far, thus creating a Swiss Prevention and Rehabilitation Registry (= SwissPR) on the basis of the KARAMBA infrastructure has the potential to collect missing data and address these questions. The results of the study will identify patient profiles at increased risk (special need patients) and will shed light into the mechanisms of poor secondary prevention behavior. The objective of SwissPR is to continuously monitor patient characteristics and short- and long-term benchmark quality measures and outcomes of patients participating in a 12-week ambulatory CR program.
For the prospective and retrospective part no recruitment or screening procedure is required. The procedure of enrolling patients for the prospective cohort of SwissPR patients is based on the participation in the CR program of the University Hospital Basel. Patients are routinely referred by various institutions for participation in the CR program according to predefined cardiovascular diagnosis. The retrospective part applies to data of patients, which have completed the CR program in Basel between 2017 and 2019.
Procedures:
Visit 1: Baseline, start of ambulatory CR program (approx. 60min): Patient characteristics including medical history, current medication, cardiovascular risk factors, routine laboratory analysis (including lipids, Hb1c, NT-proBNP), clinical status, electrocardiogram, echocardiography data from latest echo, cardio pulmonary exercise testing (CPET), questions on general health behavior (diet, weekly exercise load), Quality of Life and questions on socio-economic parameters.
Visit 2: End of CR program, 3 months after baseline (approx. 60 min.): Same measurements and procedures as at visit 1.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in an ambulatory CR program (all age groups)
- •Written informed consent
排除标准
- •Inability to follow an ambulatory CR program more than 3 weeks
- •Not willing to give informed consent
- •Inability to understand the informed consent due to language comprehension
- •Lack of discernment
结局指标
主要结局
Change in Guideline recommended medical therapy
时间窗: 1 year
Change in Guideline recommended medical therapy (Guideline recommended medical therapy is one variable in predefined secondary prevention benchmark performance measures (BPM) at one year after CR)
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: LDL-Cholesterol target value
时间窗: 1 year
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: LDL-Cholesterol target value
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: exercise/ week
时间窗: 1 year
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: Achievement of 150 minutes of exercise/ week (self-reported)
Change in smoking status
时间窗: 1 year
Change in smoking status (smoking status is a predefined secondary prevention benchmark performance measures (BPM) at one year after CR: Achievement of Non-smoking status)
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: blood-pressure (systolic and diastolic)
时间窗: 1 year
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: Achievement of target blood-pressure
次要结局
- Percentage of patients reaching the predefined secondary prevention benchmark after CR(3 months after baseline)
- Change in physical activity(up to 5 years)
- Change in total mortality after 1, 3 and 5 years(up to 5 years)
- Change in total MACE after 1, 3 and 5 years(up to 5 years)
- Change in medical therapy between visits(up to 5 years)
- Change in quality of life questionnaire/ score between visits(up to 5 years)
- Change in Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS 2P) between visits(up to 5 years)