Digital Cardiac Counseling Trial: DCC Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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)? Secondary Objective(s): - What is the effect of an interactive Digital Cardiac Counseling platform with E-consulting on patient-measured outcomes during treatment delay due to the Covid-19 pandemic measured just before, and 1 year after the cardiac surgery compared to the control condition (no interactive Digital Cardiac Counseling)? Study design: Randomized controlled trial. The investigators will use random permuted block size if technically feasible otherwise with random block sizes of 4, 6, and 8. The randomization will be computer-based and will generate two groups. Both groups will get access to the Digital Cardiac Counseling platform and both groups will complete the same set of validated questionnaires at the same time intervals. The intervention groups will get additional training modules and E-consulting based on the risk assessment retrieved from the completed questionnaires. Study population: The patient population will include any adult patient on the waiting list for any elective cardiovascular operation in MUMC (Maastricht University Medical Center) during Covid-19 pandemic. Intervention: the intervention group will receive through the Digital Cardiac Counselling platform different modules with E-counselling for risk factors evaluated in the questionnaires.The digital counselling modules for intervention group are described below: - Screening for reduced physical fitness. If there are signs for a decreased physical condition we will refer the patient, after consultation, for a digital intake with our physiotherapist. The patients then get access to a digital module with information and videos of physical exercise training. The patient gets a trainings schedule and the investigators will contact the patient after about 1 and 3 weeks to check their progression and to give additional advice when needed. Screening for smoking. If the patient smokes and is motivated to quit smoking, the investigators will refer, after consultation, for a digital intake with one of our stop smoking nurses. Then, a digital and telephone supported counselling will start after an informed and shared decision making with the nurse. When needed, supportive medication can be prescribed. Screening for malnutrition and obesity. If there are signs of malnutrition (MUST-score) or obesity (BMI >30) the investigators will refer the patient, after consultation, for a digital intake with a dietician. The patients then get access to a digital module with information about a healthy diet. The investigators will contact the patient ever 2 weeks in case of malnutrition and every 4 weeks in case of obesity. In the case of malnutrition the dietician can prescribe protein rich nutrition supplements when needed. Screening for anxiety and depression. If there are signs for anxiety and depression, the investigators will refer the patient, after consultation, for a digital intake with a psychological assistant. The patients then get access to a digital platform with information and exercises. The psychological assistant will guide the patient and will provide digital support after 1 and 3 weeks. Screening for elevated pulmonary risk score. When patients have an elevated risk score for adverse pulmonary complications (pulmonary risk score for cardiac surgery patients questionnaire) the investigators will refer the patient, after consultation, for a digital intake with our physiotherapist. The patients then get access to a digital module with information and videos of pulmonary exercise training. The investigators will send a inspiratory muscle trainer (IMT) to the patient to perform daily exercises. The patient gets a trainings schedule and the investigators will contact the patient after about 1 and 3 weeks to check their progression and to give additional advice when needed. Main study parameters/endpoints: The primary endpoint is cumulative incidence of MACE (Major Adverse Cardiovascular Events) at 1 year after cardiac surgery. The primary outcome is the difference in percentage of patients that experienced Mace at 1-year follow-up postoperatively. The investigators expect that approximately 20% of patients in the control group will experience an event. The investigators will include 197 patients per group, or 394 in total, to be able to have 80% power to detect a difference in MACE of 10% between groups in favor of the intervention group, using an alpha of 0.05.

Official Title
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Randomized Controlled Trial of Digital Cardiac Counseling in Patients With Delayed Cardiac Surgical Treatment Due to Covid-19 Pandemic (DCC Trial)

Conditions
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Cardiovascular Risk Factor, Cardiovascular Diseases

Intervention / Treatment
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* Other: Digital cardiac Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>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. | |
| Active Comparator: Intervention arm<br>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. | Other: Digital cardiac Counseling<br>* Screening for reduced physical fitness and digital counseling. Screening for smoking and digital counseling. Screening for malnutrition and obesity and digital counseling. Screening for anxiety and depression and digital counseling. Screening for elevated pulmonary risk score and digital counseling.<br>* Other names: prehabilitation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACEs | 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 | Cumulative incidence (from inclusion) at 1 year postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | all-cause 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 | 
| Cardiovascular-related mortality | Mortality caused by cardiovascular disease | Before the scheduled date of the operation, at one-year postoperatively and cumulative from inclusion at 1-year postoperatively | 
| Covid-19 related mortality | Mortality caused by Covid-19 infection and/or related complications | Before the scheduled date of the operation, at one-year postoperatively and cumulative from inclusion at 1-year postoperatively | 
| Health-related quality of life | Measured using SF (Short Form) 36 Health Survey | during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months | 
| NYHA Functional classification | New York Heart Association 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) | Grading of angina pectoris | during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months | 
| MACEs | 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 | during waiting time measured before the scheduled date of the operation, at 1-year postoperatively | 
| Perioperative complications | Respiratory failure, pneumonia, septicemia, renal failure, myocardial infarction, stroke, atrial fibrillation, pacemaker implantation, re-operation, delirium, wound infection, urinary tract infection and pressure ulcers | during waiting time measured before the scheduled date of the operation, at 30 days postoperatively and at 90 days postoperatively | 
| Hospital length of stay | from surgery until discharge in days | from the admission to the hospital untill discharge from the hospital, assessed up to 12 months | 
| Time on mechanical ventilation | measured in hours from arrival in ICU until extubation | from the admission to the ICU untill discharge from the ICU, assessed up to 12 months | 
| Smoking status | whether patient is active smoking | during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months | 
| Anxiety and Depression | Measured using HADS (Hospital Anxiety and Depression Scale) score | during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months | 
| Participation in postoperative cardiac rehabilitation | the percentage of patients taking part in postoperative cardiac rehabilitation | postoperatively at 3 months, at 6 months and at 12 months | 
| Body-Mass Index (BMI) | Percentage BMI<20 or BMI>30 | during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months | 
| Number of participants with unplanned visits | Unplanned visits to emergency department | during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months | 
| Healthcare costs | Total costs of the whole treatment process | during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Cardiac Counseling, Prehabilitation, cardiac surgical waiting list