Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03690492
Other study ID # NL65959.058.18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2, 2018
Est. completion date June 15, 2021

Study information

Verified date September 2021
Source Leiden University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to determine the effect on quality of care when introducing smart technology in patients who underwent cardiovascular surgery. Patients who consent to take part in the study, receive a box containing two smartphone compatible ECG monitors, an oxygen saturation monitor, a weight scale, a thermometer, an activity tracker and a blood pressure monitor. They will be followed up by replacing one of the outpatient clinic visits by an e-consult, in which a patients does not have to go to the hospital. Instead, he or she will talk with his or her doctor or nurse practitioner via a secured video connection. The primary endpoint of the study will be the diagnosis of atrial fibrillation within 3 months after cardiac surgery.


Description:

Over the past five years, smartphone compatible detectors of cardiovascular disease parameters have been released on the consumers market. Examples of these include heart rate monitors, ECG monitors, blood pressure monitors, activity trackers and fat percentages monitors. These monitors have often been validated and are CE-marked for use in the European Union within their intended use. Recent publications implicate that home monitoring with such consumer devices might improve quality of care. A study by Bosworth et al. in patients with hypertension showed that increased monitoring and subsequent treatment led to a better controlled blood pressure in patients who were treated for hypertension. Another study, which is currently being carried out at the LUMC, is investigating whether patients benefit from a smart technology intervention after they had a myocardial infarction. Preliminary (unpublished) results show that clinical outcomes are similar, with higher patient satisfaction. Cost analyses show that there is a cost reduction per patient with smart technology follow-up. Therefore, smart technology could be a useful tool to improve patient monitoring and therefore patient safety. Patients who are discharged after they underwent cardiovascular surgery are at risk to develop one or more of three most seen late complications: sternal wound infection, cardiac decompensation or rhythm disturbances such as atrial fibrillation. This is not always detected before those patients are discharged. Currently, patients who underwent cardiovascular surgery return to the outpatient clinic 14 days and three months after discharge. They are seen by a specialist nurse or cardiologist, who will perform a general check-up and inspect the sternal wound. An echocardiogram will be performed before the three-month visit. If there is suspicion for a rhythm disturbance on the outpatient clinic visit, the cardiologist might decide to perform Holter monitoring during 24 hours. As this is a small window of time, not all rhythm disturbances will be diagnosed. Smart technology is hypothesized to increase the chances of diagnosing rhythm disturbances. In the case of sternal wound infection and cardiac decompensation, smart technology may show a declining trend before a patient visits the outpatient clinic, which can lead to early detection and treatment. A small pilot study by McElroy et all found that after cardiovascular surgery, both the patient as well as the health care team are highly satisfied with added smart technology, due to the ease of use of the technology and platform. There was a main focus on readmission rates, which did not differ between the groups. However the trend shows an increase in diagnosing atrial fibrillation (15,4 vs 29,6%), sternal wound infection or cardiac decompensation were not studied. To our knowledge, no other study has yet looked into diagnosing late complications after cardiovascular surgery with the help of smart technology. It is hypothesized that smart technology could help diagnose the main three diagnoses mentioned above early on and with that, improve quality of care in patients after cardiovascular surgery. Therefore, in this study, the clinical effectiveness of a smart technology intervention is investigated in patients who have underwent cardiovascular surgery at the department of Thoracic Surgery at Leiden University Medical Center.


Recruitment information / eligibility

Status Completed
Enrollment 730
Est. completion date June 15, 2021
Est. primary completion date March 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient undergoes cardiovascular surgery: CABG, valve reconstruction or replacement, aortic root or ascending aortic surgery, or any other cardiothoracic surgery performed by median sternotomy such as atrial or ventricular septal defect closure, Dor or Morrow procedure, cardiac tumor removal and/or surgical treatment of coronary artery anomalies. - Patient is able to communicate in English or Dutch - Patient has been referred by a cardiologist from the Leiden University Medical Center, Cardiological Center Voorschoten, Alrijne Hospital or Haaglanden Medical Center Exclusion Criteria: - Patient is < 18 years old - Patient is pregnant - Patient is considered an incapacitated adult - Patient is unwilling to sign the informed consent form - Patient undergoes emergency thoracic surgery (INTERMACS 1 or 2) - Patient has active endocarditis at the time of operation - Patient is on mechanical circulatory support before operation - Patient has a ventricular septal rupture - Patient undergoes extracorporeal membrane oxygenation or ventricular assist device insertion

Study Design


Related Conditions & MeSH terms


Intervention

Other:
The Box 2.0
Patients in the intervention arm will receive a Box with several devices that is hypothesized to allow for better and earlier detection of complications after cardiac surgery.

Locations

Country Name City State
Netherlands Leiden University Medical Centre Leiden Zuid Holland

Sponsors (1)

Lead Sponsor Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dectection of and time to detection of atrial fibrillation Diagnosis of atrial fibrillation and the time it took a subject to reach that outcome, measured in both study arms Until 3 months after surgery
Secondary Dectection of and time to detection of cardiac decompensation Diagnosis of cardiac decompensation and the time it took a subject to reach that outcome, measured in both study arms Until 3 months after surgery
Secondary Quality of Life (QoL) QoL of both study arms, using the EQ-5D-5L (Dutch translation) 3 months after surgery
Secondary Patient satisfaction of care Satisfaction in both study arms, using a modified PSQ-18 (Dutch translation) 3 months after surgery
Secondary Overall mortality Mortality in both study arms 3 months after surgery
Secondary Major adverse cardiac events Either cardiac death, myocardial infarction, cardiac tamponade, TIA or ischaemic stroke Until 3 months after surgery
Secondary Re-admission to either the cardiology or thoracic surgery ward Re-admission in both study arms Until 3 months after surgery
Secondary Total amount of cardiology related visits to an emergency department until three months after discharge ER visits (at the Leids University Medical Center, Alrijne Ziekenhuis or Haaglanden Medisch Centrum) in both arms Until 3 months after surgery
Secondary Blood pressure control BP control in both study arms, both systolic and diastolic 3 months after surgery
Secondary Cost-effectiveness Cost-effectiveness of the intervention 2 years
Secondary Detection of and time to detection of sternal wound infection Diagnosis of sternal wound infection and the time it took a subject to reach that outcome, measured in both study arms Until 3 months after surgery
See also
  Status Clinical Trial Phase
Completed NCT04505241 - Evaluating Mechanisms of Action of Adaptive Goal-Setting for Physical Activity N/A
Completed NCT04440553 - A Mobile App to Increase Physical Activity in Students N/A
Recruiting NCT05428618 - Mobile Application for Bariatric Surgery Patients N/A
Completed NCT03174106 - Longterm Follow-up of Cardiac Patients With an Smartphone-Application N/A
Recruiting NCT06146465 - Mobile Health Applications in Pediatric Patient Management: Clinicians' Perceptions, Expectations and Experiences
Recruiting NCT05658393 - Web-based Mobile Health Application for Patients With Liver Cirrhosis (ReLiver-N App) N/A
Completed NCT03351491 - Use of Smartphone Health Applications Among Patients Aged 18 to 69 Years Recruited in Primary Care in Grenoble Area
Recruiting NCT05877729 - Intervention for Virologic Suppression in Youth N/A
Completed NCT02109601 - Patient-Centered Tablets: Applications for Inpatient Admissions N/A
Withdrawn NCT03551535 - Monitored Home Exercise in Pregnancy N/A
Completed NCT03748576 - A Prospective Randomized Controlled Trial of Mobile Medical Used for Management of Pregnant Women N/A
Recruiting NCT05951088 - Long-term Evaluation of a Mobile Application for Follow-up of Cardiac Patients (Cardio2U Study)
Completed NCT04304989 - Effects of a Video-based mHealth Program N/A
Recruiting NCT05777005 - Promoting Smoking Cessation in Campus N/A
Completed NCT02676128 - Mobile Health Application to Improve HIV Medication Adherence N/A
Recruiting NCT04606706 - A mHealth Based Education Intervention on Maternal, Infant and Young Child Nutrition to Prevent Stunting in Kelantan N/A
Completed NCT04810260 - Implementing, a Mobile Health Application for HIV Infected and Uninfected Women With Co-morbidities in the Outpatient Setting N/A
Completed NCT03778892 - Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand N/A
Recruiting NCT05430789 - Post-discharge Cessation for Smoking Patients N/A
Completed NCT02773069 - The Church as a Bridge to Deliver Health Resources Via Telehealth N/A