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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.
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:
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: -
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital cardiac Counseling | Other |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | 6202 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32139904 | Background | Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5. | |
| 10336916 | Result | Plomp J, Redekop WK, Dekker FW, van Geldorp TR, Haalebos MM, Jambroes G, Kingma JH, Zijlstra F, Tijssen JG. Death on the waiting list for cardiac surgery in The Netherlands in 1994 and 1995. Heart. 1999 Jun;81(6):593-7. doi: 10.1136/hrt.81.6.593. |
| Label | URL |
|---|---|
| Neil M Ferguson et al. Impact of non-pharmaceutical interventions (NPIs) to reduce COVID-19 mortality and healthcare demand. | View source |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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|
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 |
| 9616340 | Result | Morgan CD, Sykora K, Naylor CD. Analysis of deaths while waiting for cardiac surgery among 29,293 consecutive patients in Ontario, Canada. The Steering Committee of the Cardiac Care Network of Ontario. Heart. 1998 Apr;79(4):345-9. |
| 25240781 | Result | Malaisrie SC, McDonald E, Kruse J, Li Z, McGee EC Jr, Abicht TO, Russell H, McCarthy PM, Andrei AC. Mortality while waiting for aortic valve replacement. Ann Thorac Surg. 2014 Nov;98(5):1564-70; discussion 1570-1. doi: 10.1016/j.athoracsur.2014.06.040. Epub 2014 Sep 18. |
| 29049704 | Result | da Fonseca VBP, De Lorenzo A, Tura BR, Pittella FJM, da Rocha ASC. Mortality and morbidity of patients on the waiting list for coronary artery bypass graft surgery. Interact Cardiovasc Thorac Surg. 2018 Jan 1;26(1):34-40. doi: 10.1093/icvts/ivx276. |
| 15165741 | Result | Turner AJ, Hiscox JA, Hooper NM. ACE2: from vasopeptidase to SARS virus receptor. Trends Pharmacol Sci. 2004 Jun;25(6):291-4. doi: 10.1016/j.tips.2004.04.001. |
| 31986261 | Result | Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24. |
| 18640326 | Result | Al-Sarraf N, Thalib L, Hughes A, Tolan M, Young V, McGovern E. Effect of smoking on short-term outcome of patients undergoing coronary artery bypass surgery. Ann Thorac Surg. 2008 Aug;86(2):517-23. doi: 10.1016/j.athoracsur.2008.03.070. |
| 27835965 | Result | Grabas MP, Hansen SM, Torp-Pedersen C, Boggild H, Ullits LR, Deding U, Nielsen BJ, Jensen PF, Overgaard C. Alcohol consumption and mortality in patients undergoing coronary artery bypass graft (CABG)-a register-based cohort study. BMC Cardiovasc Disord. 2016 Nov 11;16(1):219. doi: 10.1186/s12872-016-0403-3. |
| 24894181 | Result | Guo P. Preoperative education interventions to reduce anxiety and improve recovery among cardiac surgery patients: a review of randomised controlled trials. J Clin Nurs. 2015 Jan;24(1-2):34-46. doi: 10.1111/jocn.12618. Epub 2014 Jun 3. |
| 17047215 | Result | Hulzebos EH, Helders PJ, Favie NJ, De Bie RA, Brutel de la Riviere A, Van Meeteren NL. Preoperative intensive inspiratory muscle training to prevent postoperative pulmonary complications in high-risk patients undergoing CABG surgery: a randomized clinical trial. JAMA. 2006 Oct 18;296(15):1851-7. doi: 10.1001/jama.296.15.1851. |
| 28034901 | Result | Mariscalco G, Wozniak MJ, Dawson AG, Serraino GF, Porter R, Nath M, Klersy C, Kumar T, Murphy GJ. Body Mass Index and Mortality Among Adults Undergoing Cardiac Surgery: A Nationwide Study With a Systematic Review and Meta-Analysis. Circulation. 2017 Feb 28;135(9):850-863. doi: 10.1161/CIRCULATIONAHA.116.022840. Epub 2016 Dec 28. |
| 29343294 | Result | Navaratnarajah M, Rea R, Evans R, Gibson F, Antoniades C, Keiralla A, Demosthenous M, Kassimis G, Krasopoulos G. Effect of glycaemic control on complications following cardiac surgery: literature review. J Cardiothorac Surg. 2018 Jan 17;13(1):10. doi: 10.1186/s13019-018-0700-2. |
| 29338307 | Result | Marmelo F, Rocha V, Moreira-Goncalves D. The impact of prehabilitation on post-surgical complications in patients undergoing non-urgent cardiovascular surgical intervention: Systematic review and meta-analysis. Eur J Prev Cardiol. 2018 Mar;25(4):404-417. doi: 10.1177/2047487317752373. Epub 2018 Jan 17. |
| 39396714 | Derived | Scheenstra B, van Susante L, Bongers BC, Lenssen T, Knols H, van Kuijk S, Nieman M, Maessen J, Van't Hof A, Sardari Nia P; DCC Trial Investigators. The Effect of Teleprehabilitation on Adverse Events After Elective Cardiac Surgery: A Randomized Controlled Trial. J Am Coll Cardiol. 2025 Mar 4;85(8):788-800. doi: 10.1016/j.jacc.2024.10.064. Epub 2024 Oct 11. |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |