Rehabilitation After Cardiovascular SurgeryNCT03690492
The Box 2.0: Using Smart Technology for Early Diagnosis of Complications After Cardiovascular Surgery
A study testing The Box 2.0 in people with Rehabilitation After Cardiovascular Surgery and Mobile Health, run by Leiden University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation After Cardiovascular Surgery, Mobile Health
- What is being tested?
- The Box 2.0
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 730 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Oct 2018to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patient is on mechanical circulatory support before operation
- Patient has a ventricular septal rupture
- Patient undergoes extracorporeal membrane oxygenation or ventricular assist device insertion
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Centre
Leiden, South Holland, 2333 ZA
About this study
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.
Read the detailed 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.
- Being tested
- The Box 2.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Box 2.0Other
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.
| Study group | Role | What they receive |
|---|---|---|
| The Box 2.0 | Experimental | Patients will be given a Box, in which they will find a thermometer, blood pressure monitor, activity tracker, weight scale, blood oxygen saturation monitor, a single lead ECG device and a four lead ECG device. Also, they will be followed-up by use of two webcam consultations instead of a normal outpatient clinic visit. Receives: Other: The Box 2.0 |
| Controls | No intervention | Patients will not receive a Box. They will be followed up by standard care, returning to the outpatient clinic at the same frequency and timing as The Box 2.0 arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Until 3 months after surgery
Secondary outcomes (10)
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
Measured: Until 3 months after surgery
Quality of Life (QoL)
QoL of both study arms, using the EQ-5D-5L (Dutch translation)
Measured: 3 months after surgery
Patient satisfaction of care
Satisfaction in both study arms, using a modified PSQ-18 (Dutch translation)
Measured: 3 months after surgery
Overall mortality
Mortality in both study arms
Measured: 3 months after surgery
Major adverse cardiac events
Either cardiac death, myocardial infarction, cardiac tamponade, TIA or ischaemic stroke
Measured: Until 3 months after surgery
Re-admission to either the cardiology or thoracic surgery ward
Re-admission in both study arms
Measured: Until 3 months after surgery
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
Measured: Until 3 months after surgery
Blood pressure control
BP control in both study arms, both systolic and diastolic
Measured: 3 months after surgery
Cost-effectiveness
Cost-effectiveness of the intervention
Measured: 2 years
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
Measured: Until 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start2 Oct 2018
- Primary completion15 Mar 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rehabilitation After Cardiovascular SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RoderickTreskes, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690492
- Sponsor's protocol ID
- NL65959.058.18
- Status last verified
- Sep 2021
- First submitted
- 24 Sep 2018
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biersteker TE, Boogers MJ, de Lind van Wijngaarden RA, Groenwold RH, Trines SA, van Alem AP, Kirchhof CJ, van Hof N, Klautz RJ, Schalij MJ, Treskes RW. Use of Smart Technology for the Early Diagnosis of Complications After Cardiac Surgery: The Box 2.0 Study Protocol. JMIR Res Protoc. 2020 Apr 21;9(4):e16326. doi: 10.2196/16326.
PubMed 32314974
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Box 2.0: Using Smart Technology for Early Diagnosis of Complications After Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT03690492
- Acronym / sponsor ID
- NL65959.058.18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Box 2.0 | Experimental | Other: The Box 2.0Patients will be given a Box, in which they will find a thermometer, blood pressure monitor, activity tracker, weight scale, blood oxygen saturation monitor, a single lead ECG device and a four lead ECG device. Also, they will be followed-up by use of two webcam consultations instead of a normal outpatient clinic visit. |
| Controls | No intervention | –Patients will not receive a Box. They will be followed up by standard care, returning to the outpatient clinic at the same frequency and timing as The Box 2.0 arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Box 2.0Patients 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. | Other | The Box 2.0 |
Primary outcome
Dectection of and time to detection of atrial fibrillation
Time frame: Until 3 months after surgery
Diagnosis of atrial fibrillation and the time it took a subject to reach that outcome, measured in both study arms
10 secondary outcomes
Dectection of and time to detection of cardiac decompensation
Time frame: Until 3 months after surgery
Quality of Life (QoL)
Time frame: 3 months after surgery
Patient satisfaction of care
Time frame: 3 months after surgery
Overall mortality
Time frame: 3 months after surgery
Major adverse cardiac events
Time frame: Until 3 months after surgery
Re-admission to either the cardiology or thoracic surgery ward
Time frame: Until 3 months after surgery
Total amount of cardiology related visits to an emergency department until three months after discharge
Time frame: Until 3 months after surgery
Blood pressure control
Time frame: 3 months after surgery
Cost-effectiveness
Time frame: 2 years
Detection of and time to detection of sternal wound infection
Time frame: Until 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Derived from this study: PubMed 32314974Biersteker TE, Boogers MJ, de Lind van Wijngaarden RA, Groenwold RH, Trines SA, van Alem AP, Kirchhof CJ, van Hof N, Klautz RJ, Schalij MJ, Treskes RW. Use of Smart Technology for the Early Diagnosis of Complications After Cardiac Surgery: The Box 2.0 Study Protocol. JMIR Res Protoc. 2020 Apr 21;9(4):e16326. doi: 10.2196/16326.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Box 2.0 in people with Rehabilitation After Cardiovascular Surgery and Mobile Health, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dectection of and time to detection of atrial fibrillation (time frame: Until 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03690492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.