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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54854

Enrollment

394

Registered

2020-04-30

Start date

2020-06-12

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Interventions

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 th

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)