Randomized Controlled Trial of Digital Cardiac Counseling in Patients With Delayed Cardiac Surgical Treatment Due to Covid-19 Pandemic (DCC Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- MACEs
研究概览
简要总结
Most patients undergoing a cardiovascular procedure need an ICU-bed during the hospitalization and therefore it is possible that for the unforeseen future, because of the Covid-19 crisis, many patients will stay on the waiting list for many months to come. There are some studies showing an increased mortality associated with an increased waiting time for the patients on the waiting list for an elective cardiac surgery. However, there is no data on the evolution of the morbidity, the quality of life and the symptomatology of the patients waiting for an elective operation. Also it is not clear whether the period of waiting for an elective cardiovascular operation would impact the morbidity or the mortality of the planned operation at later stage. Furthermore, there is a plethora of studies on risk factors associated with the perioperative morbidity and mortality in general. Therefore, the rationale of the current study is to evaluate whether Digital Cardiac Counseling (DCC) would improve outcomes of the patients waiting for an elective cardiac operation. At the DCC platform, there will be assessments of cardiovascular symptoms, Covid-19 prevention for cardiovascular patients, smoking cessation, anxiety relief, exercise stimulation, pulmonary rehabilitation and diet adjustments. This will be done by means of questionnaires and E-consults.
详细描述
Rationale:
Most patients undergoing a cardiovascular procedure need an ICU-bed during the hospitalization and therefore it is possible that for the unforeseen future, because of the Covid-19 crisis, many patients will stay on the waiting list for many months to come. There are some studies showing an increased mortality associated with an increased waiting time for the patients on the waiting list for an elective cardiac surgery. However, there is no data on the evolution of the morbidity, the quality of life and the symptomatology of the patients waiting for an elective operation. Also it is not clear whether the period of waiting for an elective cardiovascular operation would impact the morbidity or the mortality of the planned operation at later stage. Furthermore, there is a plethora of studies on risk factors associated with the perioperative morbidity and mortality in general. Therefore, the rationale of the current study is to evaluate whether Digital Cardiac Counseling (DCC) would improve outcomes of the patients waiting for an elective cardiac operation. At the DCC platform, there will be assessments of cardiovascular symptoms, Covid-19 prevention for cardiovascular patients, smoking cessation, anxiety relief, exercise stimulation, pulmonary rehabilitation and diet adjustments. This will be done by means of questionnaires and E-consults. Investigators start this project now because of two reasons. First, the prolonged waiting list due to the Covid pandemic creates the opportunity to use this period for cardiac prehabilitation. Second, it is only recently that the investigators got the possibility to use a digital platform, which is ideal in this period of social distancing.
Objective:
Primary Objective:
- What is the effect of an interactive Digital Cardiac Counseling platform with E-consulting on cumulative incidence of major adverse cardiovascular events (MACE) at 1 year after the cardiac surgery compared to the control condition (no interactive Digital Cardiac Counseling)?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are on the waiting list for any elective cardiac operation and are older than 18 years old (adult cardiac surgery patients) during the Covid-19 pandemic
- •Patients accepted for any elective cardiac operation and are older than 18 years during the Covid-19 pandemic (adult cardiac surgery patients)
排除标准
- •Patients who are not able to use digital platforms for various reasons (blindness, illiteracy, neurological deficits, mental inability etc.)
- •Patients who do not have an Internet connection or any digital platform and whose direct family are not able to provide that.
研究组 & 干预措施
Control arm
Participants will receive at the different time intervals through our custom-made Digital Cardiac Counselling platform different questionnaires related to the different known risk factors for the perioperative cardiac care and measured outcomes.Additional to known risk factors a Covid-19 module will be used as well.
Intervention arm
All participants will receive at the different time intervals through our custom-made Digital Cardiac Counseling platform different questionnaires related to the different known risk factors for the perioperative cardiac care and measured outcomes. Additional to above participants in the intervention group will receive through the Digital Cardiac Counseling platform different modules with E-counseling for risk factors evaluated in the questionnaires. Additional to known risk factors a Covid-19 module will be used as well.
干预措施: Digital cardiac Counseling (Other)
结局指标
主要结局
MACEs
时间窗: Cumulative incidence (from inclusion) at 1 year postoperatively
Major Adverse Cardiovascular Events defined as Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure and/or fo earlier planned intervention
次要结局
- Perioperative complications(during waiting time measured before the scheduled date of the operation, at 30 days postoperatively and at 90 days postoperatively)
- Time on mechanical ventilation(from the admission to the ICU untill discharge from the ICU, assessed up to 12 months)
- Participation in postoperative cardiac rehabilitation(postoperatively at 3 months, at 6 months and at 12 months)
- Body-Mass Index (BMI)(during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months)
- Cardiovascular-related mortality(Before the scheduled date of the operation, at one-year postoperatively and cumulative from inclusion at 1-year postoperatively)
- Smoking status(during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months)
- Number of participants with unplanned visits(during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months)
- Mortality(Before the scheduled date of the operation, at 30 days, in-hospital (at 30 days or during the same hospitalization for the planned procedure), at one-year postoperatively and cumulative from inclusion at 1-year postoperatively)
- Hospital length of stay(from the admission to the hospital untill discharge from the hospital, assessed up to 12 months)
- Anxiety and Depression(during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months)
- Health-related quality of life(during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months)
- NYHA Functional classification(during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months)
- CCS (Canadian Cardiovascular Society grading of angina pectoris)(during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months)
- Covid-19 related mortality(Before the scheduled date of the operation, at one-year postoperatively and cumulative from inclusion at 1-year postoperatively)
- MACEs(during waiting time measured before the scheduled date of the operation, at 1-year postoperatively)
- Healthcare costs(during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months)
研究者
Peyman Sardari Nia
Principal investigator
Academisch Ziekenhuis Maastricht