Remote Patient Management for Cardiac Implantable Electronic Devices (RPM-CIED)

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

Study Description

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

Condition or disease	Intervention/treatment	Phase
Arrhythmia, Cardiac	Device: Remote CIED Management	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 176 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Remote Patient Management for Cardiac Implantable Electronic Devices - A Pilot Study
• Actual Study Start Date: October 2016
• Actual Primary Completion Date: March 2019
• Actual Study Completion Date: April 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Remote CIED Management; Patients with a CIED will undergo remote monitoring with information technology.	Device: Remote CIED Management; Information Technology

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Feasibility: Feasibility will be measured by the time to implement a fully functioning system at the participating centers [ Time Frame: 6 months ]
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Canada, Nova Scotia

QEII HSC

Halifax, Nova Scotia, Canada, B3H 3A7

Sponsors and Collaborators

Ratika Parkash

Cardiac Arrhythmia Network of Canada

Medtronic

Investigators

• Principal Investigator: Ratika Parkash, MD, FRCPC; Nova Scotia Health Authority

More Information

• Responsible Party: Ratika Parkash, Staff Cardiologist, Nova Scotia Health Authority
• ClinicalTrials.gov Identifier: NCT02585817
• Other Study ID Numbers: RP-002
• First Posted: October 23, 2015
• Last Update Posted: April 25, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Ratika Parkash, Nova Scotia Health Authority:

Cardiac Implantable Electronic Devices

Additional relevant MeSH terms:

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes