Digital Cardiac Counseling Trial: DCC Trial

NCT04393636 | Completed DMC

• 1 other identifier: NL72754.068.20
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Diseases; Cardiovascular Risk Factor

Keywords

Digital Cardiac Counseling; Prehabilitation; cardiac surgical waiting list

Outcome Measures

Primary Outcomes (1)

• 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

  Cumulative incidence (from inclusion) at 1 year postoperatively

Secondary Outcomes (16)

• Mortality

  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

  Before the scheduled date of the operation, at one-year postoperatively and cumulative from inclusion at 1-year postoperatively

• Covid-19 related mortality

  Before the scheduled date of the operation, at one-year postoperatively and cumulative from inclusion at 1-year postoperatively

• Health-related quality of life

  during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months

• NYHA Functional classification

  during waiting time measured before the procedure, at 3 months, at 6 months and at 12 months

Study Arms (2)

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.

Other: Digital cardiac Counseling

Interventions

Digital cardiac Counseling OTHER

* 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.

Also known as: prehabilitation

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Ziekenhuis Maastricht: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6202 AZ, Netherlands

Location

Related Publications (15)

• 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.

  PMID: 32139904 BACKGROUND

• Plomp 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.

  PMID: 10336916 RESULT

• Morgan 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.

  PMID: 9616340 RESULT

• Malaisrie 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.

  PMID: 25240781 RESULT

• da 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.

  PMID: 29049704 RESULT

• Turner 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.

  PMID: 15165741 RESULT

• Chan 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.

  PMID: 31986261 RESULT

• Al-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.

  PMID: 18640326 RESULT

• Grabas 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.

  PMID: 27835965 RESULT

• Guo 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.

  PMID: 24894181 RESULT

• Hulzebos 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.

  PMID: 17047215 RESULT

• Mariscalco 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.

  PMID: 28034901 RESULT

• Navaratnarajah 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.

  PMID: 29343294 RESULT

• Marmelo 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.

  PMID: 29338307 RESULT

• Scheenstra 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.

  PMID: 39396714 DERIVED

Related Links

• Neil M Ferguson et al. Impact of non-pharmaceutical interventions (NPIs) to reduce COVID-19 mortality and healthcare demand.

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 19, 2020
• Study Start: June 5, 2020
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

NL (1)