Cardiovascular DiseasesDCCNCT04393636
Digital Cardiac Counseling Trial: DCC Trial
A study testing Digital cardiac Counseling in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by Academisch Ziekenhuis Maastricht at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor
- What is being tested?
- Digital cardiac Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Jun 2020to 22 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, 6202 AZ
About this study
Official title: Randomized Controlled Trial of Digital Cardiac Counseling in Patients With Delayed Cardiac Surgical Treatment Due to Covid-19 Pandemic (DCC Trial)
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.
Read the detailed description
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.
- Being tested
- Digital cardiac Counseling
- Keywords
- Digital Cardiac Counseling, Prehabilitation, cardiac surgical waiting list
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital cardiac CounselingOther
Also called prehabilitation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Digital cardiac Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Cumulative incidence (from inclusion) at 1 year postoperatively
Secondary outcomes (16)
Mortality
all-cause mortality
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: from the admission to the ICU untill discharge from the ICU, assessed up to 12 months
Smoking status
whether patient is active smoking
Measured: 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
Measured: 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
Measured: postoperatively at 3 months, at 6 months and at 12 months
Body-Mass Index (BMI)
Percentage BMI<20 or BMI>30
Measured: 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
Measured: 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
Measured: during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start5 Jun 2020
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peyman Sardari Nia, Academisch Ziekenhuis Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393636
- Sponsor's protocol ID
- NL72754.068.20
- Acronym
- DCC
- Status last verified
- Jul 2024
- First submitted
- 11 May 2020
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32139904Plomp 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.
PubMed 10336916Morgan 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.
PubMed 9616340Malaisrie 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.
PubMed 25240781da 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.
PubMed 29049704Turner 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.
PubMed 15165741Chan 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.
PubMed 31986261Al-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.
PubMed 18640326Grabas 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.
PubMed 27835965Guo 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.
PubMed 24894181Hulzebos 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.
PubMed 17047215Mariscalco 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.
PubMed 28034901Navaratnarajah 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.
PubMed 29343294Marmelo 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.
PubMed 29338307Scheenstra 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.
PubMed 39396714
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Digital Cardiac Counseling in Patients With Delayed Cardiac Surgical Treatment Due to Covid-19 Pandemic (DCC Trial)
- ClinicalTrials.gov ID
- NCT04393636
- Acronym / sponsor ID
- DCC / NL72754.068.20
- Keywords
- Digital Cardiac Counseling, Prehabilitation, cardiac surgical waiting list
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Academisch Ziekenhuis MaastrichtUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Digital cardiac CounselingAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital cardiac CounselingAlso: prehabilitation* 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. | Other | Intervention arm |
Primary outcome
MACEs
Time frame: 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
16 secondary outcomes
Mortality
Time frame: 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
Time frame: Before the scheduled date of the operation, at one-year postoperatively and cumulative from inclusion at 1-year postoperatively
Covid-19 related mortality
Time frame: Before the scheduled date of the operation, at one-year postoperatively and cumulative from inclusion at 1-year postoperatively
Health-related quality of life
Time frame: during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months
NYHA Functional classification
Time frame: 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)
Time frame: during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months
MACEs
Time frame: during waiting time measured before the scheduled date of the operation, at 1-year postoperatively
Perioperative complications
Time frame: during waiting time measured before the scheduled date of the operation, at 30 days postoperatively and at 90 days postoperatively
Hospital length of stay
Time frame: from the admission to the hospital untill discharge from the hospital, assessed up to 12 months
Time on mechanical ventilation
Time frame: from the admission to the ICU untill discharge from the ICU, assessed up to 12 months
Smoking status
Time frame: during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months
Anxiety and Depression
Time frame: during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months
Participation in postoperative cardiac rehabilitation
Time frame: postoperatively at 3 months, at 6 months and at 12 months
Body-Mass Index (BMI)
Time frame: during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months
Number of participants with unplanned visits
Time frame: during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months
Healthcare costs
Time frame: during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Background: PubMed 32139904Zheng 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.
- Results publication: PubMed 10336916Plomp 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.
- Results publication: PubMed 9616340Morgan 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.
- Results publication: PubMed 25240781Malaisrie 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.
- Results publication: PubMed 29049704da 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.
- Results publication: PubMed 15165741Turner 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.
- Results publication: PubMed 31986261Chan 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.
- Results publication: PubMed 18640326Al-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.
- Results publication: PubMed 27835965Grabas 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.
- Results publication: PubMed 24894181Guo 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.
- Results publication: PubMed 17047215Hulzebos 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.
- Results publication: PubMed 28034901Mariscalco 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.
- Neil M Ferguson et al. Impact of non-pharmaceutical interventions (NPIs) to reduce COVID-19 mortality and healthcare demand.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital cardiac Counseling in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by Academisch Ziekenhuis Maastricht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACEs (time frame: Cumulative incidence (from inclusion) at 1 year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04393636, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.