Remote Patient Management of CIEDs - Brady Devices (RPM CIED Brady)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03636230|
Recruitment Status : Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : March 23, 2020
While remote monitoring (RM) technology is currently available and has permitted surveillance and device assessment from any patient location, the use has been inconsistent in Canada, where only 8500 out of a potential 120 000 patients with cardiac implantable electronic devices (CIEDs) are enrolled in this program. This technology is in widespread use worldwide for all CIEDs but in Canada, it is utilized primarily for implantable defibrillators, but not pacemakers. Whereas most of the trials were designed to evaluate the efficacy of RM in implantable cardioverter defibrillator (ICD) patients, in the pacemaker (PM) population, there has been work performed already to demonstrate an increase in detection of frequency of adverse clinical events and a reduction in reaction time to those events by RM. Based on all the available literature, it appears that RM benefits both patients and healthcare systems. Overall, studies have demonstrated that RM can be used safely in all device patient-populations, with the exception of pacemaker-dependent patients.
There have been no studies that have evaluated RM only follow up, nor have there been any studies evaluating pacemaker-dependent patients. This study that will safely assess the use of RM only, with in-clinic visits when necessary, that uses the patient-centered electronic platform developed by the Cardiac Arrhythmia Network of Canada (CANet) to perform PM follow up safely, in a more cost-effective manner.
|Condition or disease||Intervention/treatment||Phase|
|Pacemaker||Device: Remote Monitoring Other: Standard of care||Not Applicable|
This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized in a 1:1 fashion, stratified by pacemaker dependence and by center to either remote patient management of standard of care.
Remote patient management (intervention group):
- Patients will be followed by remote monitoring only. Transmissions will occur at six monthly intervals, with no in-clinic visits. If there is an actionable event on the remote transmission, patients will be seen at their closest community device clinic. The proposed intervention would eliminate any routine visits.
- Newly implanted pacemaker patients will be seen after the initial implant at the hub site, within 48 hours and then within 3 months to optimize programming for subsequent RM visits. Thereafter, all follow-up will occur through remote monitoring every six months. Unscheduled remote transmissions may also occur. Using a combination of remote monitoring, and novel technology, VIRTUES, patients will be managed outside of the clinic.
- Patients will be provided with real-time knowledge of success of their remote transmission and the status of the remote through a web-based portal called VIRTUES.
- Virtual patient record - all patient information in the intervention arm will be contained within an information cloud that will be accessible by patients; access to their own data may be granted by the patient themselves to permit delivery of care remotely, and to permit after hours follow up to be performed by the on call personnel.
Standard of care (comparison group):
The standard arm will be required to have in-clinic visits at yearly intervals. These patients would not have access to the virtual patient cloud or to remote monitoring.
Pacemaker programming: All patients in both arms will undergo programming as per the ASSERT II protocol (previously published) to optimize pacemaker parameters and detection of atrial and ventricular high rate episodes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||848 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Open label, 1:1 randomized trial, stratified by site and pacemaker dependence|
|Masking:||None (Open Label)|
|Official Title:||Remote Patient Management of Cardiac Implantable Electronic Devices - Brady Devices|
|Estimated Study Start Date :||July 6, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||March 31, 2022|
Active Comparator: Remote Patient Management
Remote monitoring only
Device: Remote Monitoring
Remote Monitoring only
Placebo Comparator: Standard of Care
Other: Standard of care
In-Clinic visits only
- Time to major adverse cardiac event (primary safety outcome) [ Time Frame: 18 months ]Time to major adverse events (death, stroke, hospitalization for a cardiovascular cause, syncope or device-related emergency department visits). Survival free from the primary outcome will be estimated by the Kaplan-Meier method and compared, using the log-rank test. Cox proportional hazard regression analysis will be used to estimate the likelihood of survival, after verifying the proportional hazard assumption.
- Cost effectiveness [ Time Frame: 18 months ]
Analysis will take the form of a cost utility analysis with cost effectiveness assessed in terms of the incremental cost per quality life year (QALY). Analysis will incorporate data on resource use and patient's utility values for the period from initiation of remote patient management to 12 months follow-up. Resource use associated with the remote patient management strategy will be estimated through detailed microcosting and will be contrasted with the costs of standard monitoring.
QALYs will be estimated using the standard area under the cover methodology, controlling for baseline utility. Total costs and QALYs for each patient will be estimated with multiple imputation for missing data. The incremental costs and QALYs and incremental cost effectiveness ratios associated with remote patient management and the uncertainty around these will be derived through non-parametric bootstrapping.
- Quality of Life - Short Form (SF36) [ Time Frame: 18 months ]
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health
- Quality of Life - Florida Patient Acceptance Survey (FPAS) [ Time Frame: 18 months ]The FPAS produces scores that range from 0-100, where higher scores indicate increased device acceptance.
- Quality of Life - Florida Shock Anxiety Scale (FSAS) [ Time Frame: 18 months ]The FSAS produces scores that range from 10-50. Higher scores signify increased shock anxiety.
- Quality of Life - Brief Illness Perception Questionnaire (BIPQ) [ Time Frame: 18 months ]Individual item analysis will be used in this study. The personal control score is the response to item 3. The treatment control score is the response to item 4. Illness concern is measured by item 6. This reflects a combination of emotional and cognitive representations. Scores on these individual items range from 0-10 where higher scores on personal and treatment concern are reflected in higher scores. Higher scores on illness concern are reflected in higher scores.
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): NCT03636230
|Contact: Ratika Parkash, MD FRCPC||902 473 firstname.lastname@example.org|
|Contact: Karen Giddens||902 473 email@example.com|
|Principal Investigator:||Ratika Parkash, MD FRCPC||Nova Scotia Health Authority|