Pacemaker Clinical Trial
— RPM CIED BradyOfficial title:
Remote Patient Management of Cardiac Implantable Electronic Devices - Brady Devices
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.
Status | Recruiting |
Enrollment | 848 |
Est. completion date | March 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with a Medtronic or Abbott pacemaker capable of remote monitoring. - Able to provide consent. - Access to a Smartphone or Tablet Exclusion Criteria: - No access to a family physician or general practioner - Unreliable autocapture function by device in pacemaker dependent patients |
Country | Name | City | State |
---|---|---|---|
Canada | QEII Health Sciences Center | Halifax | Nova Scotia |
Canada | St. Mary's General Hospital | Kitchener | Ontario |
Canada | Hopital Sacre Coeur | Montréal | Quebec |
Canada | Hopital Laval | Quebec City | Quebec |
Canada | Memorial University of Newfoundland Hospital | Saint John's | Newfoundland and Labrador |
Lead Sponsor | Collaborator |
---|---|
Ratika Parkash |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to major adverse cardiac event (primary safety outcome) | 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. | 18 months | |
Primary | Cost effectiveness | 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. |
18 months | |
Secondary | Quality of Life - Short Form (SF36) | 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 |
18 months | |
Secondary | Quality of Life - Florida Patient Acceptance Survey (FPAS) | The FPAS produces scores that range from 0-100, where higher scores indicate increased device acceptance. | 18 months | |
Secondary | Quality of Life - Florida Shock Anxiety Scale (FSAS) | The FSAS produces scores that range from 10-50. Higher scores signify increased shock anxiety. | 18 months | |
Secondary | Quality of Life - Brief Illness Perception Questionnaire (BIPQ) | 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. | 18 months |
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