PORTuguese Research on Telemonitoring With CareLink® (PORTLink)

Arrhythmia Clinical Trial

— PORTLink  

Official title:

PORTuguese Research on Telemonitoring With CareLink® (PORTLink)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125382
• Other study ID #: PORTLink
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: October 2016

Study information

• Verified date: May 2023
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac

Intervention

Device:
• Carelink System
Patients start to perform device data transmission through Carelink system
• In office standard visit
Patients start or maintain in office standard visits

Locations

Country	Name	City	State
Portugal	Hospital Hospitalar do Algarve	Faro
Portugal	Centro Hospitalar de Alto Ave - Unidade de Guimarães	Guimarães
Portugal	Centro Hospitalar Lisboa Central- Hospital de Santa Marta	Lisboa
Portugal	Centro Hospitalar do Porto	Porto
Portugal	Centro Hospitalar de Setúbal	Setúbal
Portugal	Centro Hospitalar Vila Nova de Gaia/Espinho	Vila Nova de Gaia

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Device Related Adverse Events	compare number of Device-related Adverse Events	12 months visit
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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