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Digital Cardiac Counseling Trial: DCC Trial (DCC)

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ClinicalTrials.gov Identifier: NCT04393636
Recruitment Status : Not yet recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Peyman Sardari Nia, Academisch Ziekenhuis Maastricht

Brief 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 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Cardiovascular Risk Factor Other: Digital cardiac Counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial of Digital Cardiac Counseling in Patients With Delayed Cardiac Surgical Treatment Due to Covid-19 Pandemic (DCC Trial)
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
No Intervention: Control arm
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.
Active Comparator: Intervention arm
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.
Other: Digital cardiac Counseling
  • 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 Name: prehabilitation




Primary Outcome Measures :
  1. MACEs [ Time Frame: Cumalative incidence (from inclusion) at 1 year postoperatively ]
    Major Adverse Cardiovascular Events


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Before the scheduled date of the operation, at 30 days, in-hospital, at one-year postoperatively and cumulative from inclusion at 1-year postoperatively ]
    all-cause mortality

  2. Cardiovascular-related mortality [ Time Frame: Before the scheduled date of the operation, at one-year postoperatively and cumulative from inclusion at 1-year postoperatively ]
    Mortality caused by cardiovascular disease

  3. 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 ]
    Mortality caused by Covid-19 infection and/or related complications

  4. Health-related quality of life [ Time Frame: during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months ]
    Measured using SF 36 questionnaire

  5. NYHA Functional classification [ Time Frame: during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months ]
    New York Heart Association Functional Classification

  6. CCS grading of angina pectoris [ Time Frame: during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months ]
    Canadian Cardiovascular Society grading of angina pectoris



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393636


Contacts
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Contact: Peyman Sardari Nia, MD, PhD 0031-433875070 peyman.sardarinia@mumc.nl
Contact: Jos Maessen, MD, PhD 0031-433875070 j.g.maessen@mumc.nl

Sponsors and Collaborators
Academisch Ziekenhuis Maastricht
Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: Peyman Sardari Nia, Principal investigator, Academisch Ziekenhuis Maastricht
ClinicalTrials.gov Identifier: NCT04393636    
Other Study ID Numbers: NL72754.068.20
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peyman Sardari Nia, Academisch Ziekenhuis Maastricht:
Digital Cardiac Counseling
Prehabilitation
cardiac surgical waiting list
Additional relevant MeSH terms:
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Cardiovascular Diseases