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…
ID
Source
Brief title
Condition
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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. We expect that approximately 20% of patients in the
control group will experience an event. We 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.
Secondary outcome
The percentage of patients that experienced a MACE during the waiting period
will be compared between groups similar to the primary outcome. We will use
Kaplan-Meier plots to illustrate the cumulative incidence of overall and
cardiovascular-related, and COVID-19-related mortality over the 1 year
follow-up period. Cox proportional hazards regression will be used to test for
differences between groups. The model will be extended with covariates
(Possible confounders are Euroscore II, type of the operation, operation time,
cross-clamp time and unforeseen intraoperative complications) in case of
baseline imbalance.
Differences between groups in the average NYHA Class, CSS, and SF-36 at 3, 6,
and 12 months will be tested using the independent-samples t-test, or linear
regression in case of baseline imbalance.
Background summary
Most patients undergoing a cardiovascular procedure need an IC-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 increased mortality
associated with the increased waiting time for patients on a 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 Counselling (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.
We 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 we got the
possibility to use a digital platform, which is ideal in this period of social
distancing.
Study 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
We 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. The complete workflow is depicted
in Figure 1.
Intervention
All 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 above participants, the intervention group will receive through
the Digital Cardiac Counselling platform different modules with E-counselling
for risk factors evaluated in the questionnaires. Additional to known risk
factors a Covid-19 module will be used as well.
Study burden and risks
The risk of participation is negligible to the patients and the burden of
participation of the control group will be minimal. For the intervention group
the burden of the participation is more pronounced as more Digital Cardiac
Counselling moments are anticipated. However this increased burden is for
addressing the increased perioperative risk factors and therefore we hope that
patients in the intervention group will benefit from this (however this is not
certain en subject of the study). Furthermore all patients will undergo the
same standard of care.
P. Debyelaan 25
Maastricht 6202 AZ
NL
P. Debyelaan 25
Maastricht 6202 AZ
NL
Listed location countries
Age
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 Covid-19
pandemic
-Patients accepted for any elective cardiac operation and are older than 18
years during 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73754.068.20 |