Arrhythmia
Conditions
Brief summary
Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (ICD)
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.
Interventions
DEVICECarelink System
Patients start to perform device data transmission through Carelink system
DEVICEIn office standard visit
Patients start or maintain in office standard visits
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patient Satisfied or Very Satisfied With Carelink | 12 months visit | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings | 12 months visit | Through the semi-quantitative evaluation of physician satisfaction with CareLink System. Used rating: Very Satisfied; Satisfied; neither satisfied nor dissatisfied; dissatisfied and very dissatisfied |
| Health Care Consumed Resources Between Groups Relative to Unscheduled Visits | 12 months visit | Number of in office unscheduled visits will be calculated per arm and compared with each other |
| Number of Device Related Adverse Events | 12 months visit | compare number of Device-related Adverse Events |
| Improvement in Quality of Life | 12 months visit | 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. |
| Number of Unanticipated Serious Adverse Device Effects (USADE) Rate | 12 months visit | 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 |
| Compare Patient Consumed Resources Between Groups | Baseline | 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 |
Countries
Portugal
Participant flow
Recruitment details
Recruitment start - 01 Apr 2012 Recruitment end - 30 Apr 2015 Location - In Hospital
Pre-assignment details
There were 7 screening failures;
Participants by arm
| Arm | Count |
|---|---|
| In Office Standard Visit-New Patients with new implants who do not perform device data transmission through Carelink system
In office standard visit: Patients start or maintain in office standard visits | 37 |
| In Office Standard Visit-Previous Patients with previous implants who do not perform device data transmission through Carelink system
In office standard visit: Patients start or maintain in office standard visits | 28 |
| Carelink - New Implants Patients with new implants who perform device data transmission through Carelink system
Carelink System: Patients start to perform device data transmission through Carelink system | 35 |
| Carelink - Previous Implants Patients with previous implants who perform device data transmission through Carelink system
Carelink System: Patients start to perform device data transmission through Carelink system | 34 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Follow-up | Death | 1 | 2 | 1 | 2 |
| Follow-up | Lost to Follow-up | 1 | 4 | 3 | 1 |
| Randomization | screening failure | 1 | 4 | 2 | 0 |
Baseline characteristics
| Characteristic | In Office Standard Visit-Previous | Carelink - New Implants | In Office Standard Visit-New | Carelink - Previous Implants | Total |
|---|---|---|---|---|---|
| Age, Continuous | 62.0 years STANDARD_DEVIATION 15.2 | 56.5 years STANDARD_DEVIATION 13.7 | 57.9 years STANDARD_DEVIATION 11.3 | 63.8 years STANDARD_DEVIATION 10.9 | 59.9 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 7 Participants | 4 Participants | 27 Participants |
| Sex: Female, Male Male | 22 Participants | 25 Participants | 30 Participants | 30 Participants | 107 Participants |
| Type of Device Cardiac Resynchronization Therapy Defibrillator | 9 Participants | 8 Participants | 11 Participants | 10 Participants | 38 Participants |
| Type of Device Implantable Cardioverter Defibrillator | 19 Participants | 27 Participants | 26 Participants | 24 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 37 | 2 / 28 | 1 / 35 | 2 / 34 |
| other Total, other adverse events | 1 / 37 | 2 / 28 | 0 / 35 | 1 / 34 |
| serious Total, serious adverse events | 1 / 37 | 2 / 28 | 1 / 35 | 2 / 34 |
Outcome results
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
Time frame: 12 months visit
Population: Only applicable for Carelink arms
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carelink - New Implants | Number of Patient Satisfied or Very Satisfied With Carelink | 34 Participants |
| Carelink - Previous Implants | Number of Patient Satisfied or Very Satisfied With Carelink | 34 Participants |
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
Time frame: Baseline
Population: It was pre-specified to combine In Office Standard Visit-New and In Office Standard Visit-Previous Arms/Groups and Carelink - New Implants and Carelink - Previous Implants Arms/Groups for this analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carelink - New Implants | Compare Patient Consumed Resources Between Groups | More than 15€ | 20 Participants |
| Carelink - New Implants | Compare Patient Consumed Resources Between Groups | Up to 5 € | 23 Participants |
| Carelink - New Implants | Compare Patient Consumed Resources Between Groups | 5 - 15 € | 21 Participants |
| Carelink - Previous Implants | Compare Patient Consumed Resources Between Groups | Up to 5 € | 23 Participants |
| Carelink - Previous Implants | Compare Patient Consumed Resources Between Groups | 5 - 15 € | 26 Participants |
| Carelink - Previous Implants | Compare Patient Consumed Resources Between Groups | More than 15€ | 20 Participants |
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
Time frame: Baseline
Population: It was pre-specified to combine In Office Standard Visit-New and In Office Standard Visit-Previous Arms/Groups and Carelink - New Implants and Carelink - Previous Implants Arms/Groups for this analysis
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Carelink - New Implants | Compare Patient Consumed Resources Between Groups | Travel time | 30 Minutes |
| Carelink - New Implants | Compare Patient Consumed Resources Between Groups | Time at the hospital | 80 Minutes |
| Carelink - Previous Implants | Compare Patient Consumed Resources Between Groups | Travel time | 30 Minutes |
| Carelink - Previous Implants | Compare Patient Consumed Resources Between Groups | Time at the hospital | 95 Minutes |
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
Time frame: 12 months visit
Population: It was pre-specified to combine In Office Standard Visit-New and In Office Standard Visit-Previous Arms/Groups and Carelink - New Implants and Carelink - Previous Implants Arms/Groups for this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carelink - New Implants | Health Care Consumed Resources Between Groups Relative to Unscheduled Visits | 1.1 visits | Standard Deviation 0.9 |
| Carelink - Previous Implants | Health Care Consumed Resources Between Groups Relative to Unscheduled Visits | 0.4 visits | Standard Deviation 0.6 |
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.
Time frame: 12 months visit
Population: It was pre-specified to combine In Office Standard Visit-New and In Office Standard Visit-Previous Arms/Groups and Carelink - New Implants and Carelink - Previous Implants Arms/Groups for this analysis~Within each group, nonparametric Wilcoxon rank-sum test for paired samples was used to determine the statistical significance of changes on anxiety, depression and SF-12 scores. Changes in HADS anxiety and depression scores, SF-12 were evaluated by analysis of covariance (ANCOVA) models
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Carelink - New Implants | Improvement in Quality of Life | SF12 physical component | -1.1 score change |
| Carelink - New Implants | Improvement in Quality of Life | SF12 mental component | 0.4 score change |
| Carelink - New Implants | Improvement in Quality of Life | HADS anxiety | 0 score change |
| Carelink - New Implants | Improvement in Quality of Life | HADS depression | 0 score change |
| Carelink - Previous Implants | Improvement in Quality of Life | HADS depression | 0 score change |
| Carelink - Previous Implants | Improvement in Quality of Life | HADS anxiety | 0 score change |
| Carelink - Previous Implants | Improvement in Quality of Life | SF12 mental component | 0.0 score change |
| Carelink - Previous Implants | Improvement in Quality of Life | SF12 physical component | 0.0 score change |
Secondary
Number of Device Related Adverse Events
compare number of Device-related Adverse Events
Time frame: 12 months visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carelink - New Implants | Number of Device Related Adverse Events | 0 Participants |
| Carelink - Previous Implants | Number of Device Related Adverse Events | 0 Participants |
| Carelink - New Implants | Number of Device Related Adverse Events | 0 Participants |
| Carelink - Previous Implants | Number of Device Related Adverse Events | 0 Participants |
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
Time frame: 12 months visit
Population: It was pre-specified to combine In Office Standard Visit-New and In Office Standard Visit-Previous Arms/Groups and Carelink - New Implants and Carelink - Previous Implants Arms/Groups for this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carelink - New Implants | Number of Unanticipated Serious Adverse Device Effects (USADE) Rate | 6 adverse event |
| Carelink - Previous Implants | Number of Unanticipated Serious Adverse Device Effects (USADE) Rate | 4 adverse event |
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
Time frame: 12 months visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carelink - New Implants | Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings | satisfied | 25 satisfaction at each transmission |
| Carelink - New Implants | Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings | dissatisfied | 0 satisfaction at each transmission |
| Carelink - New Implants | Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings | neither satisfied nor dissatisfied | 0 satisfaction at each transmission |
| Carelink - New Implants | Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings | Neither satisfied nor dissatisfied | 0 satisfaction at each transmission |
| Carelink - New Implants | Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings | very satisfied | 98 satisfaction at each transmission |
| Carelink - Previous Implants | Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings | Neither satisfied nor dissatisfied | 0 satisfaction at each transmission |
| Carelink - Previous Implants | Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings | very satisfied | 80 satisfaction at each transmission |
| Carelink - Previous Implants | Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings | satisfied | 47 satisfaction at each transmission |
| Carelink - Previous Implants | Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings | neither satisfied nor dissatisfied | 0 satisfaction at each transmission |
| Carelink - Previous Implants | Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings | dissatisfied | 0 satisfaction at each transmission |