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Trial record 1 of 1 for:    NCT02585817
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Remote Patient Management for Cardiac Implantable Electronic Devices (RPM-CIED)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02585817
Recruitment Status : Completed
First Posted : October 23, 2015
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
Cardiac Arrhythmia Network of Canada
Medtronic
Information provided by (Responsible Party):
Ratika Parkash, Nova Scotia Health Authority

Tracking Information
First Submitted Date  ICMJE October 16, 2015
First Posted Date  ICMJE October 23, 2015
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
Generalizability: Measurement of generalizability will be done by measuring the number of patients eligible for remote patient management as a proportion of all CIED patients. [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • Feasibility: Feasibility will be measured by the time to implement a fully functioning system at the participating centers [ Time Frame: 6 months ]
  • Compliance (number of received remote transmissions divided by the number of expected remote transmissions) [ Time Frame: 12 months ]
    Compliance to remote patient management will be measured for patients by the number of received remote transmissions divided by the number of expected remote transmissions.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
  • Feasibility: Feasibility will be measured by the time to implement a fully functioning system at the participating centers [ Time Frame: 6 months ]
  • Compliance (number of received remote transmissions divided by the number of expected remote transmissions) [ Time Frame: 18 months ]
    Compliance to remote patient management will be measured for patients by the number of received remote transmissions divided by the number of expected remote transmissions.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remote Patient Management for Cardiac Implantable Electronic Devices
Official Title  ICMJE Remote Patient Management for Cardiac Implantable Electronic Devices - A Pilot Study
Brief Summary

This is a pilot study to assess barriers, evaluate and implement a patient oriented CIED management model incorporating advanced technological innovation to promote a paradigm shift to patient-centered care involving remote CIED monitoring and programming. The advancement in technology is very important as it addresses several potential gaps and barriers in the care of patients with CIEDS:

  1. Long, expensive travel for patients
  2. Morbidity to patients due to delay in receiving appropriate treatment
  3. Efficiency in health care delivery
  4. Patient satisfaction
Detailed Description

Canada is a country with a diverse geography, of which 19% of the inhabitants are in communities classified as 'rural', but many may still have long distances to travel to reach a health care facility. This results in challenges in uniform delivery of health care throughout the country. There are 25,000 pacemaker (PM) implants and 7000 implantable defibrillator (ICD) implants yearly in Canada, with approximately 120 000 patients living with these devices. The recommended follow-up for these devices are based on consensus and position statements, with the majority of patients requiring at least yearly visits to a specialized device clinic during the lifetime of their device. During the life of these patients, many issues may arise, such as atrial or ventricular arrhythmias that may result in syncope, stroke or sudden death, need for increased monitoring resulting from device advisories, or minor programming adjustments to improve device performance, or simply the need for enhanced surveillance as the device battery depletes and replacement is anticipated.

While remote monitoring technology is currently available and has permitted surveillance and device assessment from any patient location accessible to a landline or mobile phone, the use has been inconsistent in Canada. In addition, new technology has become available that not only permits surveillance, but also remote programming of these devices. The incorporation of remote programming capability, along with automatic recalibration of device settings, allows us to develop a new paradigm of remote patient management where after the patient receives their device, they would remain in the care of their local health team and no longer require travel to the specialized 'hub' clinics for follow-up.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Arrhythmia, Cardiac
Intervention  ICMJE Device: Remote CIED Management
Information Technology
Study Arms  ICMJE Experimental: Remote CIED Management
Patients with a CIED will undergo remote monitoring with information technology.
Intervention: Device: Remote CIED Management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2019)
176
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2015)
400
Actual Study Completion Date  ICMJE April 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with an implanted pacemaker/cardiac resynchronization therapy with a pacemaker(CRT-P) capable of remote patient management would be eligible for the study that will be followed by the site where the implantation occurred OR patients with an implanted defibrillator/CRT-D capable of remote patient management where the patients reside in a community OUTSIDE of the site where the implantation occurred. The device may be de novo, existing or a patient undergoing a pulse generator change that now has remote patient management capabilities.
  2. Able to provide consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02585817
Other Study ID Numbers  ICMJE RP-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ratika Parkash, Nova Scotia Health Authority
Study Sponsor  ICMJE Ratika Parkash
Collaborators  ICMJE
  • Cardiac Arrhythmia Network of Canada
  • Medtronic
Investigators  ICMJE
Principal Investigator: Ratika Parkash, MD, FRCPC Nova Scotia Health Authority
PRS Account Nova Scotia Health Authority
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP