PORTuguese Research on Telemonitoring With CareLink® (PORTLink) (PORTLink)

Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (ICD)

Study Overview

• Status: Completed
• Conditions: Arrhythmia
• Intervention / Treatment: Device: Carelink System; Device: In office standard visit

Detailed Description

The objective of the PORTLink (PORTuguese Research on Telemonitoring with CareLink), a multicenter randomized study, is to assess the safety, functioning and costs of remote ICD monitoring when compared to traditional in-clinic follow-up. It will evaluate aspects such as the clinician and patient acceptance and satisfaction with the reviewing device data via the website, the complexity for troubleshooting calls to the support center, the utilization of emergency resources by symptomatic patients, the percentage of the unscheduled appointments after a remote interrogation, the levels of anxiety, depression and quality of life, and the main consumed resources with CareLink System.

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Faro, Portugal, 8000-386
    • Hospital Hospitalar do Algarve
  • Guimarães, Portugal, 4835-044
    • Centro Hospitalar de Alto Ave - Unidade de Guimarães
  • Lisboa, Portugal, 1169-1024
    • Centro Hospitalar Lisboa Central- Hospital de Santa Marta
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto
  • Setúbal, Portugal, 2910 - 446
    • Centro Hospitalar de Setubal
  • Vila Nova de Gaia, Portugal, 4434-502
    • Centro Hospitalar Vila Nova de Gaia/Espinho

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subject has implanted Medtronic Implantable Cardioverter Defibrillator: CRT-D (Cardiac Resynchronization Therapy - Defibrillator), ICD
• Subject or the subject's caregiver is willing and able to use the Medtronic CareLink Monitor and perform the required duties at home or have a family member or assistant to perform those studies
• Subject has signed a Patient Informed Consent Form from this study

Exclusion Criteria:

• Subject has medical condition(s) that would limit study participation (e.g. hearing or speech impaired with no family member or assistant available)
• Subject is less than 18 years of age
• Subject is enrolled or intends to participate in another clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: In office standard visit-New; Patients with new implants who do not perform device data transmission through Carelink system	Device: In office standard visit; Patients start or maintain in office standard visits
Active Comparator: In office standard visit-Previous; Patients with previous implants who do not perform device data transmission through Carelink system	Device: In office standard visit; Patients start or maintain in office standard visits
Experimental: Carelink - New Implants; Patients with new implants who perform device data transmission through Carelink system	Device: Carelink System; Patients start to perform device data transmission through Carelink system
Experimental: Carelink - Previous Implants; Patients with previous implants who perform device data transmission through Carelink system	Device: Carelink System; Patients start to perform device data transmission through Carelink system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patient Satisfied or Very Satisfied With Carelink	through the semi-quantitative evaluation of patient satisfaction with Carelink System and their preference when compared to traditional in-clinic follow-up, the options were: 1) Very Satisfied; 2) Satisfied; 3) Not Satisfied nether Unsatisfied; 4) Unsatisfied; 5)Very Unsatisfied	12 months visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Device Related Adverse Events	compare number of Device-related Adverse Events	12 months visit
Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings	Through the semi-quantitative evaluation of physician satisfaction with CareLink System. Used rating: "Very Satisfied"; "Satisfied"; "neither satisfied nor dissatisfied"; "dissatisfied" and "very dissatisfied"	12 months visit
Health Care Consumed Resources Between Groups Relative to Unscheduled Visits	Number of in office unscheduled visits will be calculated per arm and compared with each other	12 months visit
Compare Patient Consumed Resources Between Groups	Attribute patient travel costs to low, middle and high costs and then compare patient travel costs between the group with in office visits versus Carelink, measured at baseline	Baseline
Compare Patient Consumed Resources Between Groups	Patient time consumption in visits between the groups at baseline visit Arms were combine: In office standard visit combined: Office Standard Visit-New + In Office Standard Visit-Previous; Carelink combine: Carelink - New Implants & Carelink - Previous	Baseline
Improvement in Quality of Life	Health-related quality of life was measured with an adapted version of the SF-12 questionnaire, a 12-item generic measure derived from the Short-Form 36. It evaluates physical functioning, limitations due to physical health problems, bodily pain, energy/fatigue, social functioning, limitations due to emotional problems, and psychological distress and well-being. Physica lcomponent summary and mental component summary measures were estimated, with higher scores indicating better health status (range from 0 to 100). Mental health wellbeing was measured with the Hospital Anxiety and Depression Scale (HADS), which consists of a series of 14 questions, seven related to anxiety (HAD-A) plus other seven questions related to depression (HAD-D). Scores of 0-7 for the two subscales are regarded as normal, scores of 8-10 suggest the presence of a mood disorder and scores ≥11 suggest a probable mood disorder.	12 months visit
Number of Unanticipated Serious Adverse Device Effects (USADE) Rate	compare number of Unanticipated Serious Adverse Device Effects (USADE) Arms were combine: In office standard visit combined: Office Standard Visit-New + In Office Standard Visit-Previous; Carelink combine: Carelink - New Implants & Carelink - Previous	12 months visit

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Investigators: Principal Investigator: Mário Oliveira, Doctor, Centro Hospitalar Lisboa Central

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: PORTLink

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No