Randomized controlled trial of Digital Cardiac Counseling in patients with delayed cardiac surgical treatment due to Covid-19 pandemic (DCC trial)

Recruiting

Conditions: Cardiac Surgery
10007593

Registration Number: NL-OMON54854

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 394

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is cumulative incidence of MACE (Major Adverse<br /><br>Cardiovascular Events) at 1 year after cardiac surgery. The primary outcome is<br /><br>the difference in percentage of patients that experienced Mace at 1-year<br /><br>follow-up postoperatively. We expect that approximately 20% of patients in the<br /><br>control group will experience an event. We will include 197 patients per group,<br /><br>or 394 in total, to be able to have 80% power to detect a difference in MACE of<br /><br>10% between groups in favor of the intervention group, using an alpha of 0.05.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The percentage of patients that experienced a MACE during the waiting period<br /><br>will be compared between groups similar to the primary outcome. We will use<br /><br>Kaplan-Meier plots to illustrate the cumulative incidence of overall and<br /><br>cardiovascular-related, and COVID-19-related mortality over the 1 year<br /><br>follow-up period. Cox proportional hazards regression will be used to test for<br /><br>differences between groups. The model will be extended with covariates<br /><br>(Possible confounders are Euroscore II, type of the operation, operation time,<br /><br>cross-clamp time and unforeseen intraoperative complications) in case of<br /><br>baseline imbalance.<br /><br>Differences between groups in the average NYHA Class, CSS, and SF-36 at 3, 6,<br /><br>and 12 months will be tested using the independent-samples t-test, or linear<br /><br>regression in case of baseline imbalance.</p><br>